Release Merged

CONTROLLED
COPY
nano : ' ;'{ ;' \ ':)' {
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}:: i’\
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{-:{:}#;K;;
Document No Department:
Title: Quality Format for Bacterial Endotoxin Test of finished product ! Quality Control
QF/acM 003
Microbiology
Product Name \
a a
Batch No. / Lot No of Testing
Date of Report Ana:ysis Report No rl

• 06
F= Kr> B
Manufacturing Date Expiry Date
r e (S a
Sample Identification No. ®6BTi3 a BBB
a
Reagent Details:
r--––-'–--
i a€ag:at V:fG ./ Lot No. Exp ItV Cate Reh7dration/Opening Date }
tAL Reagent
J.
; CSI
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:\'l ; xi : T-: I. iT" \,/B ! : :: :I ' : = ' . : = ; >. = 0.8 /- 0.125 : 5.4 > -: = = = 3 J /2 : 3.2
:-:--- .et =, E.L-=:nCetox in Li'i-it. c.= =':; EU/':evic€?. N= NG of De\-i=e , :Y = To::i: volume. >,= : TSS :e 5£rr'„ T
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CSE (Pi} LAL Reagent (+!} ; ,-;b$ervatien !
e 50 {4 \)
30 ,,MVD 2)
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Abbre','; 3tion Se! TC rllja t.iGn, :' --" . No Sci Formal !: : ' N -vv C" bbB ter Coat f 3 :
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A:Eat; /e Product Control, 'P'tVC": Oosji Ive V,’3ter control, “PPC": >ss;::\,e Product
:cn Irc:. "\_=:Cq" \ LAL Reagent Water, CSE": Control Starlcard £ndo toxIn, ''EJ'' : :rc::to.'in J
Limit: 20EU//Device /
Resul{: The bacteriai endotoxin test of given sample cob'pites / does not comply with the ,t,suIt as per in-house
test method QTh.4/C}CMFPOC3
Analysis By Reviewed By: e \at el

Sign Sign
nb pc+a
Date Date
! q - c)[ m-.
Revision No.: 03 Effective Date: 0142-2022 Page: 1 of 1

f"'i i:i !-l LI
CONTROLLED
COPY N3/\$"!- 1ii Cfl){:>'I
a Document No Titje: Qua;itV Form it for Certificate of Arla!:/sis for Residual Ethylene Dep3rtn lent:
QF/QCOIS Oxide, Residual Fthylene Gtvcnl and Residua! Ethylene Chlorohvdriae Quality Control
PrQduct Name: allO/ih,Inr Flu+i ' rl
Analysis Report No.: /UrAl \a& l__IA.

Batch No.: Qaa Zoo
Received Date: Analysis Date
C - OJ - ROZ-Q-– IQ-as- Q.aeR
Sampling (By„:
Q_l_@E_. _ Sample ?_y:_©Q.£QQM=_A23 C A .WIUg
Me. Date: o$.o£-QDq{ _EjPT_ _t=: OM£dg_+A_.
l
Test/
S Ncb Specification Result
i Parameter
i
I Residual Ethylene Oxide = =Fruit N. IU T 25 pprn
No+
! Residual
Residual Ethylene Glytol ; LImIt N.M. T 250 pom
• I ETO Tube No t !!>e4cc+.
Jade
I
! Residual Ethylene Chtorohvdrine = Limit N.M. T 25 ppm
\//
Inspection Result. - Batch passes/dose not passes as per inspectIon
Rr?fi’.'tlnce: C)1 M/FP0-l2
; PI'c!}Jar cd By Revi. Apprf.,vcd By

L #7
! SiRtl : Sign SiD!'I
i
Date . Date
F6 -as>4 bl
\:::::I___..X=!_,_2a _ I _ 2-D 27_
nIne n+ n+ nOMenaea++nn anneH,n nbOnHUq+HH#nVVW# PVa ++an=nu=+nnHnHUnHnHBnan+ FeBHIKe+anIbHa VaPe • P nn• wenun+oHnnB•UB•bn• +'ann U+n• • U U+•+•'O•• W +H+• B ++++••O•n••+++T++•
unanHn ema=u•amu•W •H•B+ • O ' no B•lb•UbW UUbOPeep n==+=MS-H
Revisit.+n Nap ' OZ Effect iTC T)atc: (•l-lO'20;iQ Page: 1. o! I

KONARK RESEARCH FOUNDATION
TESTING & CALIBRATION LABORATORY
Plot No 338/1 . Behind Patel Cricket Ground,Kachigam, Daman & Diu, 396210
Regd.Office:333, Adhyaru Industrial Estate,Sunmill Compound, Lower Parel,
Mumbai (MH) 4000013
,DH,INDIA
4&':;FAto< saleskrf@konarkgroup.com
Testing & CalibratIon Laboratory
CERTIFICATE OF ANALYSIS
CERTIFICATE NO. : KRFR/2782/22-23
Certificate Issued To : NANO THERAPEUTICS Pvr.LTD

D-54/2,Hojiwala Industrial Estate„Sachin
SURAT,GJ,394230
1. Name Of Sample : Sirolimus Eluting Coronary Stent System 2. Batch No : 22080016
3. Date Of Manufacture : 09-05-2022 4. Date Of Expiry : 2024-05-08
: 01 NOS 6. Batch Size : NM

5. Sample Quantity
7. Reference No.(Party) : NM 8. Sample Received On : 11/05/2022
Analysis Results
Tests Parameters
I Result
Residual Solvent (By H.S.G.C.}
Ethylene Oxide Not Detected
Ethylene Glycol Not Detected
Ethylene Chlorohydrine Not Detected
'-' END OF REPORT 'm
Note : Party asked for above tests only.

Analyst Sign. : NP Date : 12/05/2022 Authorj
!:qi1:Lt
Note : 1. Sample not drawn by us.
2. Sample will be destroyed after testing. •?:l:}I

3. This report cannot be used as an evidence in the court of law or any media without prior permission.
Page 1 Of 1
KONARK RESEARCH FOUNDATION-DAMAN
y
KRFR / 2782 / 22-23
i)–j;;i8ri[i;EQU/INS/483
Analysed: 12-05-2022 12:12
Sample ID: Blank
Analysis type: UnkNown
Chromatogram filename: C:\TRACEGC\Residul ETO 0225.dat
1500 A
1185
e
870
(mVolt)
555
240
-75 -
0.0 4.0 7.999 (min) 1 1 .999 15.999 19.998
Numb e r Retention Time Area Area % Component Name

(min ) ( . 1 + uV+ sec ) (%)
9.528 206431900 100.000 Di 1 ue nt
206431900
Warning Chroma to gram has been subjected to manual integration
Analysed By:- $$DUO Checked By:

KRFR / 2782 / 22-23
Operator ID:EQU/INS/483
Analysed: 12-05-2022 12:37
Sample ID: Std 01
W
1500 A a
1185
e
870 -
(mVolt)
555
=
C)
nI
(D
240 ED
L II
-75 '
0.0 4.0 7.999 (min) 1 1 .999 15.999 19.998
Numb e r Retention Time Area Area % Component Name

(min ) ( . 1 + uV+ sec ) ( %)
2.278 2116 0.001 E TO

6.483 3983893 1.651 EG
6.740 7109624 2.946 ECH
9.528 230264800 95.403 Dil trent
24i3i640i
Warning Chroma tog ram has been subjected to manual integration .
SICn
DATE
Analysed By:- bJtAi0 Checked By: ),r–

KRFR / 2782 / 22-23
Analysed: 12-05-2022 13:15
Sample ID: Std 02
1500 A
1185
870
(mVolt)
555
E
C)
rTI
240 !gl
gEl
Ah
-75 -
0.0 7.999 (min) 1 1 .999 15.999 19.998
Peak Number Retention Time Area Area % Component Name

) (min) ( . 1 + uV+ sec ) (%)
2.275 2211 0.001 E TO
2 6.477 3860823 1.825 EG
3 6.733 6669233 3.152 ECH
4 9.528 201072700 95.023 Di lu ent
}iiioiioo
Warning Chroma tog ram has been subjected to manual integration
Analysed By:- KOgAn\3 Checked By:

(r)'F-
@
KONARK RESEARCH FOUNDATION-DAMA
KRFR / 2782 / 22-23
'Sample Name: Sirolimus Eluting Coronary Stent System
Analysed: 12-05-2022 14:30
,Sample Serial No: 22050086-003
Sample ID: 2782
[Batch No : 22080016 Channel A
;Chromatogram filename: C:\TRACEGC\Residul ETO 0229.dat
1500 A +
-a
1185
e
870
(mVolt)
555
240 -
-75 ----–------'--'-T---'--–-
0.0 4.0 7.999 (min) 11 .999 15.999 19.998
Number Retention Time Area Area % Component Name

(min ) ( . Ie uV+ sec ) (%)
9.637 233836800 100.000 Diluen t
}3iiiiio6
Warning Chroma tog ram has been subjected to manual integration
Analysed WU\al) Checked By:

q)a’–
ria rio
CQNTRO'' TO COPY MASTI COP
Document No
QF/QC012
mMopiF=igTe-i;;l;;r-sl=>limus
.:uting hrorla ’Stent System
M Quality Control
Date: Analysis Report No: : (9( -IMP - Do gOO 16 -- 6 o )

CiS--to 22-
mmme: - 6\€oltrr\qS t=\u ++n 3 can 6 ten+ Aj3t cwI
Batch No ao go. Ie
Sample CIty nam F1 e
Sample S No, 920XOO 3G .-o\r1 SVXZ
Std. Drug Lot No Std. Drug CIty
a' Tav\ / U /.q6/Dt –P\
Mfg. Da-te: -
Xlme;' Og -0 )-_2026
Observation: .
A. Observation Table 1: -
e Weight of
Stent Before Weight of Stent
After Drug
Coating
Weight
Total
Theoretical
Drug Amount
Sample Drug C03ting Loading
S No.
Coating (mg} !mg}
Limit
hg)
tmg>
tKg)
(B-A) (B-A) x 0 3642
x IOOO
9:z05D03 6 -dS-} 2 ll . go S 25–. 203 O.',02 1339-413 i t'tG.3.66
Weight of Stent Difference in Amoun: of Drug Drug Loading

After-Sterile& Weight After €xpand Limit
Sample Expand (alg) { mg I t Kgl tBg>
S No
(C.A) X 0.3642
(B-C)
xl000
220rDO gd -art 2 g. \'tS– 1'l3.',I'IS II? - IS-O
B. Observation Table ::
r
hTf. After erIca in
! Sample S No. Initial Wt. (alg)
Analysis (ing) Weight (lng)
L
228 fo036 -Os-1 24 () 2’I . Vh O.04 z cleqE
C. Observation Table 3: •
Actual Loading HPI,C Result Drug Uvit
I
Sanip£e S No.
i:l8} tBg} tRgi
220W'36 -oi-1 ]!! e . 4 gB_5 FaI . 6, lz3 -1
Revision No.: Q2 Effeclive Date: 01-10-2020 Page : 1 of 3

It Piano
CONTRa’,
’ CD COPY q+ + Hr n =r n% A
MASTER COPy
Document No Title: Quality Format for Drug Irnpurity Testing Report for Sirolimus I Department
QF/Qc012 Eluting Coronaw Stent/Stent System Quality Control
D. Observation Table 4: -
Total impurities
Sirolimuslsomer I Sirolimus lsomer Sirolimus (excluding
Sample S No. A 1 B lsomer C Sirolimus lsomer
(%i I c%) (%) A & Sirolimus
lsomer C) (%)
220£oo.3( –on (') \OS- q6.\l o.13

Limit NMT 0.5 % NLT 95.0 % NMT 1.0 %
E. Observation Table 5: .
Standard Are
Drug Standard No
(Volt)
Sirolimus Standard No. 1
4ZoS130
4 lr63 1 2
/I )FIg}/1
2, 1852%I
Sirotimus Standard No. 5 d/I11601 )
Average /t18$qz3 . go
Standard Deviation I 't 2+b–. 6 G
%RSD (Limit: Not More Than 2.0 %) o . 36
E._C31£_ulatjgr!! -
Mean Std. Area = St + N b +• ,td,N

5
Me'In 6+d . #7eq At051 innaTE+ 74 +41€£i

S
e M''“) 6+d 1\X eq ZI 1 %%923 LO
Mean Std. PPM = Std.No.1+ Std.No.2+ Std.No.3+ Std.No.4+ Std.No.S

5
2 +–lol .q T + mJF+lm
\vI eq“I 6+d F PIVI
5
t~lean 6+ct . PPM = IOI. 31
Drug in ppm = Sample Area Y Mean Standard PPM
Mean Standard Area
DGu3 -IV) Perf) - \ A'IS veg X 302.33

zI \T%123 . 2o
JX£'48 t.. Erpt = 31. zI \
Revision No.: 02 Effective Date: 01.10-2020 Page : 2 of 3

=' !_ n d ncl
CONTROI' ED er)PY + n Map = r =
MASTER. COPy
Drug in Fg = Drug in ppm X Quantity of ACN (mI)
Ii)'ug in JIg
,a/-
Conclusion: - The sample complies/does not comply as per specification.
Reference: . QTM/FP003
Analysis By Reviewed BY: J) el Approved By: b

bq
at
Sign SIgn: j D/>C/1 Sign
Date Date
Date: FI- OS- >ALL I l'CS-hoW
e Abbreviation :
Micro gram
Miili Grarll
Parts Per Mliiir),I
Seri31 Number
Standard
Relative ane
Acetonitrile
Revision No.: 02 Effective Date: 01-10-2020 Page: 3 of 3

NAN O THERAPEif TICS PVT,LTD ,
System ConfiguraHon
<<Instrument>>
Instrument Name : QC-H PLC-002
Sample Information
Acquired by ; Mittal Patel
Project Name : RM & FP Analysis
Sample Name : Blank ACN-
Sample ID : Blank
Data File : Blank ACN-11-05-2022-01.lcd
Batch File : May-2022-001.lcb
Tray# 4
Vial# 1
Injection Volume : 20
Method File : Nano-3(Sirolimus Impurity).Icm
Date Acquired : 5/11/2022 2:06:30 PM
Chromalograln
I Detector A 277n
e
0.0
\
Jo
0.0 2.5 5.0 7.5 10.0 12,5 15.0 1 7.5 20.0 22.5 25.0 27.5 30.0
min
Chromatogram
uV
1 Detector A 277nI
2500
Il
+J"–- \
L-
\
e 0.0 2.5 5.0 7.5 1 G.0 1 2.5 1 5.0 1 7.5 20.0 22.5 25.0 27.5 30.0
min
Peak Table Blank ACN-11-05-2022-01.lcd

etector A 277nm
-Peak#
Tota ll
_NarM BPW Mr Area nBl Ur a
Analysis By: Mittal Patel Reviewed By;Deepak Patel
Sign : ')Dp4el
Date:11-05-2022 Date:11-05-2022
NANO THERAPEUTICS PVT,LTD ,
System Configuration
<<Instrument>>
Instrument Name : CIC-HPLC-002
Sample Information
Acquired by : Mittal Patel
Sample Name : Blank ACN-
Sample ID : Blank
Data File : Blank ACN-11-05-2022-02.lcd
Tray# :4
Vial# 1
Date Acquired : 5/11/2022 2:36:49 PM
Chromatogram
mV
I Detector A 277n
e 2.5
0.0–
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
mIn
Chromatogram
uV
1 Detector A 277n
250
e 0.0 2.5 5.0 7.5 10.0 12.5 1 5.0 1 7.5 20.0 22.5 25.0 27.5 30.0
min
Peak Table Blank ACN-11-05-2022-02.lcd

Detector A 27,7nm
Peak# [ Name Ret. Time Area 1 Area% i Cortc. Unit } Tailing Factor ITheoretical Plates/meterlUSP
Total
Analysis By: Mittal Patel Reviewed By:Deepak Patel
Sign: 3)bP del

Date: 11-05-2022 P Date: 11-05-2022
NANO THERAPEX:JTICS PVT.LTD .
<<Instrument>>
Instrument Name : QC-HPLC-002
Sample Information
Sample Name : Sirolimus Std. 100 ppm-
Sample ID : Sirolimus Drug-
Data File : Sirolimus Std. 100 ppm-11-05-2022-01.lcd
Batch File ; May-2022-001.lcb
Tray# 4
Vial# 2
Date Acquired : 5/11/2022 3:07:08 PM
Chromatogram
1 Detector A 277
e
r–r–-–
25.0 27.5 30.0
rnln
1 Detector A 277
e 10.0 12.5 7.5 20.0 27.5 30.0

min
Peak Table Sirolimus Std. 100 ppm-11-05-2022-01.lcd
Peak# Name Ret. Time Area Area% Conc Unit a 'meter{USP

1 Unknown 10.71 2442 0.05 2.45 lm 0.94 T01887
2 Unknown 11.17 2408 0.05 1.32 1.07 112171
3 Unknown 14.32 4797 0.11 0.38 Im 0.97 205744
4 Unknown 14.85 10352 0.23 0.48 m 1.05 188073
5 Sirolimus A-lsomer 15.52 a7 34 1.06 0.44 rn 0.96 103543
6 Sirolimus B-lsomer 17.70 4205130 94.29 102.79 m 1.09 89375
7 Sirolimus C-lsomer 19.09 184363 4.13 0.34 0.96 239343
8 Unknown 19.98 3000 0.07 0.18 m 0.97 233946
Tota 4459825 100.00 108.36
Sign: ]bbp4&IL
Date: 11-05-2022 Date:11-05-2022
NANO THERAPEUTICS PVT.LTD .
<<Instrument>>
Sample Information
Sample Name ; Sirolimus Std. 100 ppm-
Data File : Sirotimus Std. 100 ppm-11-05-2022-02.lcd
Tray# 4
Vial# 2
Date Acquired : 5/11/2022 3:37:26 PM
Chromatogram
1 Detector A 277
Detector A 277n
e 0.0 2.5 10.0 12.5 15.0 7.5 20.0 22.5 25.0 27.5 30.0
min
Peak# Name Ret. Time Area Area% Conc. r leoretical Platl Fmeter( USP
r 10.70 2204 0.05 2.21 Fm 0.97 108571
r 11.16 2475 0.06 1.35 m 0.99 106306
r 14.31 5214 0.12 0.42 m 1.04 194113
r 14.84 10233 0.23 0.47 m 1.06 189230
1 15.52 46845 1.05 0.43 m 0.97 104301
iSrbhmus B-lsomer 17.69 4196312 94.29 102.57 m 1.09 89933
mI ia-no ir 19.09 184176 4.14 0.33 m 0.96 238120
8 Unknown 19.97 2819 0.06 0.17 m 0.99 237224
Total 4450279 100.00 107.95
Sign: Wp4ol
Date:11-05-2022 Date:11-05-2022
NANO THERAPEUTICS PVT.LTD. J
<<Instrument>>
Sample Information
Tray# 4
Vial# 2
Date Acquired : 5/11/2022 4:07:46 PM
Chromatogram
mV
1 Detector A 277
e
10.0 12.5
Chromatogram
uV
1 Detector A 277
e 0.0 2.5 5.0 7.5 10.0 12.5 15.0 1 7.5 20.0 22.5 25.0 27.5 30.0
Peak# Name Ret. Time Area Area% Conc. Unit a ’meter(USP

1 Unknown 10.71 2239 0.05 2.24 Im 0.98 103296
2 Unknown 11.16 2469 0.06 1.35 Im 0.99 108622
3 Unknown 14.33 4824 0.11 0.39 Im 0.95 207849
4 Unknown 14.85 9859 0.22 0.45 Im 1.09 195201
5 Sirolimus A-lsomer 15.53 47158 1.07 0.44 0.96 103309
6 Sirolimus B-lsomer 17.71 4171874 94.29 101.97 1.09 89905
7 Sirolimus C-lsomer 19.10 183199 4.14 0.33 m 0.96 239269
8 Unknown 19.97 2669 0.06 0.16 Fm 0.98 256778
Tota 4424291 100.00 107.33
Analysis By: Mittat Patel Reviewed By:Deepak Patel
Sign: ')t>pet el
Date:11-05-2022 Date:11-05-2022
<<Instrument>>
Instrument Name ; CIC-HPLC-002
Sample Information
Sample Name : SECS Impurity Testing-
Sample ID Sirolimus Drug-
Data File : 22050036-051-Impurity Testing-.lcd
Tray# 4
Vial# 6
Date Acquired : 5/11/2022 6:09:06 PM
Chromatogram
mV
T) 8 1 Detector A 277n
E E
a 0
6 5a
E
gi
an d
3
E
E=
NO
a b I
Dt;5 ;:A
0.0 T
2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
Chromatogram
uV
1 Detectom
5000
250a
-i:
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
Peak Table 22050036-051-ImpurityTesting-.lcd

Detect
Peak# Name Ret. Time Area Area% Conc Unit Factor leoretical Pr @
1 Unknown 14.90 2046 0.14 0.09 m 1.01 135542
2 Sirolimus A-lsomer 15.60 790 0.05 0.01 rn 1.11 144496
3 Sirolimus B-lsoM 17.74 1448865 96.12 35.41 m 1.07 89675
To 1507378 100.00 35.62
Sign: DDR'L
Date:11-05-2022 Date: 11-05-2022
<<Instrument>>
Sample Information
Tray# 4
Vial# 2
Date Acquired : 5/11/2022 6:39:25 PM
Chromatogram
mV
1 Detector A 277n
e
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
min
Chromatogram
uV
1 Detector A 277n
e 0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
min

E
Peak# Name Ret. Time Area Area% Conc. Unit Tailin Factor eoretical Plates/meter( USP
1 Unknown 10.77 2303 0.05 2.31 r11 0.96 T07980
2 Unknown 11.22 2429 0.05 1.33 rT1 0.96 113552
3 Unknown 14.38 4628 0.10 0.37 Fm 0.91 218686
4 Unknown 14.91 10217 0.23 0.47 m 1.07 194577
5 Sirolimus A-lsomer 15.58 47417 1.07 0.44 m 0.97 104540
7 Sirolimus C-lsomer 19.15 184421 4.14 0.34 Fm 0.96 244598
8 Unknown 20.02 2628 0.06 0.16 Fm 1.08 263451
Tota 4449331 100.00 107.95
Sign: 32)Pd&e
Date:11-05-2022 Date:11-05-2022
NANO THEIIAPEtJTICS PVT,LTD ,
<<Instrument>>
Sample Information
Sample Name ; Sirolimus Std. 100 ppm-
Tray# 4
Vial# 2
Date Acquired : 5/11/2022 7:09:45 PM
Chromatogram
mV
1 Detector A 277
e
0.0 2.5 5.0 7.5 10.0 12.5 15.0 7.5 1 20.0 22.5 25.0 27.5 30.0
min
Chromatogram
uV
1 Detector A 277n
e 0.0 2.5 5.0 7.5 10.0 12.5 1 5.0 17.5 20.0 22.5 25.0 27.5 30.0
Peak# Name let. Time Area Area% Conc Unit a

1 Unknown 10.77 2458 0.06 2.46 m 0.93 ro1113
2 Unknown 11.22 2450 0.06 1.34 rn 1.00 110578
3 Unknown 14.39 4507 0.10 0.36 m 0.90 226305
4 Unknown 14.91 10234 0.23 0.47 m 1.06 191925
5 Sirolimus A-lsomer 15.59 47416 1.07 0.44 m 0.96 103909
8 Unknown 20.02 2873 0.06 0.17 m 1.04 243928
Tota 4429272 100.00 107.65
Sign: )Dp4bl
Date:11-05-2022 Date:11-05-2022
ria rio
CQNTRO'' TO COPY MASTI COP
Document No
QF/QC012
mMopiF=igTe-i;;l;;r-sl=>limus
.:uting hrorla ’Stent System
M Quality Control
Date: Analysis Report No: : (9( -IMP - Do gOO 16 -- 6 o )

CiS--to 22-
mmme: - 6\€oltrr\qS t=\u ++n 3 can 6 ten+ Aj3t cwI
Batch No ao go. Ie
Sample CIty nam F1 e
Sample S No, 920XOO 3G .-o\r1 SVXZ
Std. Drug Lot No Std. Drug CIty
a' Tav\ / U /.q6/Dt –P\
Mfg. Da-te: -
Xlme;' Og -0 )-_2026
Observation: .
A. Observation Table 1: -
e Weight of
Stent Before Weight of Stent
After Drug
Coating
Weight
Total
Theoretical
Drug Amount
Sample Drug C03ting Loading
S No.
Coating (mg} !mg}
Limit
hg)
tmg>
tKg)
(B-A) (B-A) x 0 3642
x IOOO
9:z05D03 6 -dS-} 2 ll . go S 25–. 203 O.',02 1339-413 i t'tG.3.66
Weight of Stent Difference in Amoun: of Drug Drug Loading

After-Sterile& Weight After €xpand Limit
Sample Expand (alg) { mg I t Kgl tBg>
S No
(C.A) X 0.3642
(B-C)
xl000
220rDO gd -art 2 g. \'tS– 1'l3.',I'IS II? - IS-O
B. Observation Table ::
r
hTf. After erIca in
! Sample S No. Initial Wt. (alg)
Analysis (ing) Weight (lng)
L
228 fo036 -Os-1 24 () 2’I . Vh O.04 z cleqE
C. Observation Table 3: •
Actual Loading HPI,C Result Drug Uvit
I
Sanip£e S No.
i:l8} tBg} tRgi
220W'36 -oi-1 ]!! e . 4 gB_5 FaI . 6, lz3 -1
Revision No.: Q2 Effeclive Date: 01-10-2020 Page : 1 of 3

It Piano
CONTRa’,
’ CD COPY q+ + Hr n =r n% A
MASTER COPy
Document No Title: Quality Format for Drug Irnpurity Testing Report for Sirolimus I Department
QF/Qc012 Eluting Coronaw Stent/Stent System Quality Control
Total impurities
Sirolimuslsomer I Sirolimus lsomer Sirolimus (excluding
Sample S No. A 1 B lsomer C Sirolimus lsomer
(%i I c%) (%) A & Sirolimus
lsomer C) (%)
220£oo.3( –on (') \OS- q6.\l o.13

Limit NMT 0.5 % NLT 95.0 % NMT 1.0 %
E. Observation Table 5: .
Standard Are
Drug Standard No
(Volt)
4ZoS130
4 lr63 1 2
/I )FIg}/1
2, 1852%I
Sirotimus Standard No. 5 d/I11601 )
Average /t18$qz3 . go
Standard Deviation I 't 2+b–. 6 G
%RSD (Limit: Not More Than 2.0 %) o . 36
E._C31£_ulatjgr!! -
Mean Std. Area = St + N b +• ,td,N

5
Me'In 6+d . #7eq At051 innaTE+ 74 +41€£i

S
e M''“) 6+d 1\X eq ZI 1 %%923 LO
Mean Std. PPM = Std.No.1+ Std.No.2+ Std.No.3+ Std.No.4+ Std.No.S

5
2 +–lol .q T + mJF+lm
\vI eq“I 6+d F PIVI
5
t~lean 6+ct . PPM = IOI. 31
Drug in ppm = Sample Area Y Mean Standard PPM
Mean Standard Area
DGu3 -IV) Perf) - \ A'IS veg X 302.33

zI \T%123 . 2o
JX£'48 t.. Erpt = 31. zI \
Revision No.: 02 Effective Date: 01.10-2020 Page : 2 of 3

=' !_ n d ncl
CONTROI' ED er)PY + n Map = r =
MASTER. COPy
Drug in Fg = Drug in ppm X Quantity of ACN (mI)
Ii)'ug in JIg
,a/-
Analysis By Reviewed BY: J) el Approved By: b

bq
at
Sign SIgn: j D/>C/1 Sign
Date Date
Date: FI- OS- >ALL I l'CS-hoW
e Abbreviation :
Micro gram
Miili Grarll
Parts Per Mliiir),I
Seri31 Number
Standard
Relative ane
Acetonitrile

-) I
T L,} E J ip,a il. J: ,\ IA- 1’'\"' '!' +' ,.., +.T, ,94.
COPY /
CONTROL„I..ED anH f11Pad irBPP

I L ; 8'h' p C L+ : + #U„ Xy} ; if i
Document No. : i
Department:
i
U••HP
QF/QCOIO :
I
Tit ie
J QupInY Con:raI
IO -OS - 2022 Analysis Report No: -ac _ LO D _ 220 'goo t 6 _oo I
Product NaraO ) i m US
Cb®nq\] Stem t 635 nrr)
Gm.: - 12c) goc>16 Sample CIty o \ SampIE
Sample S No.
r. 22'Dc:16 d - oo I (g .OOXsa)
2
i
i
Std, Drug Lot No.: -dlc/('>Lt4/L5 / o'Ie /O t +) Std. -Drug CIty. 1+ 8am
L+-
M'i:- n'!?: ' al - OF- 202L ExpirY Date: . o6 - o3– Lai;i
Observation : „
e A. Observation Table i: .
WeiBht af
Weight of Stent Coating Theoretical
Stent Before Total
After Drug Weight Drug Amount
Sample Drug Coating
S No. (mB)
Coating (mg) (mg)
Loading
Limit I CnD
I B €}'8)
i (B-A) (B-A) x O.3642
x ltlOO
f
i}- 220
I
3–o066 - oo t
-– . --..- ---.. .-.-.–.-
S2 . x 7 g' 1 53.285–
g'}ji--tErTjLj:B)
I
b’/ri.':! it of Stent
DiNer,or, ii'-- [- –XK=,FJ-ai,T----i"=;ff;;;; a--!
i Anal St:File &! Weight : Af\or iIiJar, d i Lilrlit
Sample
S No.
! Expand jmg) i (mIB) i jpg} } (Pg)
i
e
i
i
(BO jC-A) X 0.3642 xIDOg
220JD OC C -oo)
Li----I O , ooh 2Ft . 6746 937 - 2qo
B. Observ’,tion Table 2: -
I –-
I Wt, After
Sample InItial \\t\. !
;
I Analvsis
S No, ('rl g) : Diff"eT:= W'i$ht ; SuNace
=•nibH +U ' ,Van n nUnn nv
(mg)
I
22D nIa C6 – OO t
i SQ.IVE €2 . s \3 (n \ eq
_.. +J, .
H=HdHqnHH
n#gBU’+n=hBnubv+n4r nrHPVbIP adl•PnnpU nnW•
3={='JiSif)iI ?Ifi; Gi eff:':'IN.: Date: Gi„:la-2020 PaBe: 1 of 1

). r'J .S
CONTRQt: :D CCPY -=3,._IIi::i
IiI + O PP t ; A• • + I
fab
;hh = • •• :r
=H
')
Hient:
De{IDF:
I ; ::o::: No •t : 11 H T i I• !: :: e a :i t v Fo r m a t f o r D r ug Load iag Analysis Qua;itV Controt
Results: -
Sample AcldaI Drl'g Loading HPLC Result Drug LimIt

S No jFg) hg) €bg)
220FooCd –ooI 261.131'I 2 S? . o o 23}-21 o
C, Observation Table 3: -
Drug Standard No Standard Area (Volt)
6} aol Ifr,’'IS 6++'n ct'led NOs I cM

a aol )mHS Sh *ldq FJO_ 2 d1 3bH
3faol i rugS €&4ndq£d fao dll q3–II
\
6 i Eal ; m-IS 6+4 Ttdq Cd t\jO. 21 (g\q26gy
14/it ;rrtu ShY\ d'I &l NO. i Cl &H
Average
Gt 3 qq al . oo
Standard Deviation
91 +1', . or
%RSD {Limit: Not More Than 2.0 %}
O. 'Is
D. CaiculatSc;R : +
Meail Sti! . Area = Std.No.1+ Std.No.?+ Std.No. 3+ Std.No.4+ Std.No.5

5
tH eaRn 6+d , BIte,q : 6,186 '') 1 t £t30 632-t- d-'%tab-+Z-ta-aiRT diAl- b–

e- q:
Mean 6+d. AVe'I = £J3'112-q+ oo
e i Mean Std. PPM = Std.No.1+ Std.No.2+ SId,ryo.3+ Std,No,q+ Std.No.5
M :q n 6 N . ppM : 1 q:%–+-T–-i&il–AT+–-i-'b–-I–'–6 S'+--l-d-'S:-G=FIX jT-n–---––I

S
MCq“I Ota . eeM : IOt-t)
Drug in pplr = Sample Area X Me:i: 5tand3rd PPM

Mean Standard Area
pPm = 3;::jl2q.ol X l02' }
tDeus i'r\ PPm= 6zr ' aS
Revision Flu. : C:\: it-II Li *:t\ hJa ! :: : C I. "'I :jn ,>'1iT :i',Li PagE = = c:
CONTReit. ED COPY
i: { i"-') gO q i:';!;!\$-FE:::i. <:<::3i-)V
Document No Department
Title: QuaIIty Format for Drug Loading Analysis
QF/QCOIO quality Control
Drug in pg = Drug in ppm X aa i
D.£y3 IT) liS
X-/
Analysis By: Reviewed BY: j>eebc>f. Approved By a .& go

Sign
Date
a/
& Date: /O _ aS_>4 } ==
Sign
Date
.H&agI
Abbreviation
Pg mjra r,i
mg Milli Gram
PPM Parts Per Million
S No Serial Number
St& Standard
RSD Relative Standard DeviatiJR
PPM Parts Per Million
MeoH Methanol

<<Instrument>>
Instrument Name ; QC-HPLC-002
Sample Information
Sample Name : Blank MeoH-
Sample ID : Blank
Data File : Blank MeoH-10-05-2022-01.lcd
Batch File : Loading & Release .lcb
Tray# 3
Vial# I
Injection Volume ; 20
Method File : Nano-1(Sirolimus Loading & Release).Icm
Date Acquired : 5/10/2022 9:51:08 AM
Chromatogram
mV
1 Detector A 276n
A
e 0.75
0.5
0.25
0.01
J\+ V -\ r
If
-', \I
-0.25
0.0 5.0 7.5 1 0.0 12,5 15.0 17.5 20.0
min
Peak Table Blank MeoH-10-05-2022-01.lcd

)etect
Peak# Ret. Time Area%
e mr a
Tata
Sign:
_-)bF4el
Date:10-05-2022 Date: 10-05-2022
1 /1
yANO THERAPEUTICS PVT.LTD .
<<Instrument>>
Instrument Name : C}C-HPLC-002
Sample Information
Sample ID : Blank
Tray# 3
Vial# 1
Date Acquired : 5/10/2022 10:11:27 AM
Chromatogram
mV
1 Detector A 276n
I
e 0.75
0.50
0.25
0.0
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min
Peak# Name Ret. Time Area% r nFr

e Tata
3,bp del
Sign:
Date:10-05-2022 Date : 10-05-2022
1/ 1
NANO THERAPEUTICS_ PVT.LTD
<<Instrument>>
Sample Information
Sample Name : Sirolimus Std. 10C)ppm-
Data File : Sirolimus Std. 100ppm-10-05-2022-01.lcd
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 10:37:47 AM
1 Detector A 276
Peak Table Sirolimus Std. 100ppm-10-05-2022-01.lcd

B IS
P'e;Ii# Name Area Area% r a
e
Conc.
I 6186099 9 rn 1.11 14708
I 257346 3.99 0.00 m 1.04 31860
Tota 6443445 mrim
Sign:
J)Pd eC
Date:10-05-2022 Date: 10-05-2022
1/ 1
<<Instrument>>
Instrument Name ; QC-HP LC-002
Sample Information
Sample Name : Sirolimus Std. 100ppm-
Data File : Sirolimus Std. 10C)ppm-10-05-2022-02.lcd
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 10:58:06 AM
Chromatogram
mV
1 Detector A 27
n•
15.0
Pda 1:# Name Area Area% Conc. r eoretical Plat Fmeter(USP

e I
I
6130836
255501
mm1
4.00 0.00
Im
Im
1.11
1.03
14657
32201
no 6386337 afoldia
Sign:
a)Dpael
Date:10-05-2022 Date:10-05-2022
1/ 1
NANO THERAPEUTICS PVT ,LTD ,
<<Instrument>>
Sample Information
Sample Name : Sirolimus Std. lac)ppm-
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 11:18:24 AM
Chromatogram
mV
1 Detector A 27
min
Peak Table Sirol imus Std. 100ppm-10-05-2022-03.lcd
feat:# Name Ret. Time Area Area% Conc. r a Fmete ISP

I 12.38 6114599 mm1 rn 1.12 14605
I 15.63 254219 3.99 0.00 m 1.03 32188
Tota 6368819 mm1
,,.,Dj, pdal
Date:10-05-2022 Date : 10-05-2022
1/ 1
NANO THERAPEUTI_C)_PVT.LTD .
<<Instrument>>
Sample Information
Sample Name : SECS Loading Sample-
Data File : 22050066-001-Loading-.lcd
Tray# 3
Vial# 6
Method File ; Nano-1(Sirolimus Loading & Release).Icm
Date Acquired : 5/10/2022 12:39:38 PM
Chromatogram
1 Detector A 276nr
;B
1 \6
e /:\i
/ tg
i IE
/E
if
/\
5a \- \
I U
I I F
e
I [
25- /
C)
I \
B
I \ E
\
E
tB
0-
\
\- q,
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17,5 20.0

min
Peak Table 22050066-001-Loading-.lcd

Detect
Peak# Name Area Area% Conc Unit Tailin a aaa 'meter(USF
HIM a1Bma 3863663 96.55 64.25 bm 1.12 14760
£Bir8hmus C-lsom& 137956 3.45 0.00 Im 1.03 32047
Tota 4001619 100.00 64.26
Sign : DE,pd'L
Date:10-05-2022 Date: 10-05-2022
L
,aPP-

<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Method File : Nano-l(Sirolimus Loading & Release).Icm
Date Acquired : 5/10/2022 8:37:06 PM
1 Detector A 27

Detectl :6
Peak# Name Area Area% Conc r torettcal P FmeterfUSP
@ TMsbA; 6142638 bmlm rn 1.13 14960
1 oZ 254520 3.98 0.00 rn 1.02 32364
To' 6397159 MMbITom
Sign:
'bb Ntl
Date:10-05-2022 Date: 10-05-2022
1/ 1
\l

<<Instrument>>
Sample Information
Batch File ; Loading & Release .lcb
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 8:57:24 PM
Chromatogram
1 Detector A 276n
Peak Table Sirolimus Std. 100ppm-lO-05-2022-05.lcd

2Z6
Fe; k# Name Ret. TirrTe Area Area% Conc r
m9 m
lretical Plates/meter(USP
I 12.17 6125473 rn 1.13 14918
mIO 15.33 254878 3.99 0.00 Im 1.03 32762
6380351 mal

D
;“: CD „g': ,)V#£
Date:10-05-2022 Date:10-05-2022
1/ 1
iRt
I
!’- i Hall
CONTRO!* ED COP' MASTeR, COPY
14 i Dccufnerit No, : -Tmmit7F I);;,'I-a lit;iii it; R;ie;ii Report for Sirolimus Eluting Department
#
i qF/clcall CoronarY Stent/Stent System Quality Control
' ' - )
T.:.--.JZ_-a£=/a7z Analy;is Report No: - Or a.

Product Name: -3/2 d\irnU£
F luM j+tnt viI
mI Sample S No,
'aS aaB H L
s= =U g = / / 1EF$11;aSf)g
tw N£15 / ab ad. Drug (Itv.
I .Oa rg
HiB-CD Conc
MTg' Vale: ' dJ -aS -aZ

(}bserv?tion: -
A. Observation Table 3 : -
Weight of
Weight of Sjgn Coating Theoretical
Stent Before Total
e E
i
Sarnpl£:
S lea
Drul, Coating
in
After Drug
Coating (mg)
Weight
(mg)
Loading
Limit
Drug Amount
{Kg>
A (B-A) (Bg I (B.A) x

0.3642 x IOOt)
22g50 a3 A - OdZI gHZ, ad } la5.7ja

Weight of Stent i Difference in } Araourt of Drug ) Drug Loa jing– ]
i
I After Sterile & : Weight : Aaer ExpanJ i UnIit !
SanIpl q
I
i S Ido,
i etrpond (mB) ! {nIE} ! (1,g) : jpg) :
i
F
ig-c> fC-Ajf;i';842 i
+- t
:22d5oo3P ' #97 i Jg.mg E

I
_L
\ )ga . If)2
_.,___
\
.. Ii
R Oh:.?Fw=tiol! Table !: -
i Stint i NL::": \ j2–'jiJ£b :' iiI

Analysis TotatCumulutive I HPLC Res Actual Result Cumulative i Cumulative
Date Hour } {ppm) (Kg I Amount (pg) } %
Tr__,__.___[_2_.JJ\._b.U_SS_ – IIla_.as __
??. iEa:
[Jg_:__„3rZ„Z t_.III__.
_.___,___I_/jg_ !__Za„'_..I_/_ I__.M,
LIL :LWZ
:._/g = @.g// ]. ,. J.g..dg f/_4_ 1 4%Sd
\] e _' _@ -Zg2g
_lo. - aS_- yg22 I i. _a, J g
b ,IZ
O. bio_
ix7,/73
\. .#_4_
a3
V3 _at_
2/: }'Irs
}„I. reS 'Z?ZZ
39i-Irs
1.o ._aL_ _.;_.ZIg_ ]{ .3.1
I
! o.o t _.j_g.g +{ __L{{'as
; \ 2' aS -2o22 '";'::::':;,:;:::“'"6.%? DI2 ! Jo). //
J
Revision No.: Q3 Effective Date: 01-07.2021 Page: 1 of 7

::" il 8 rl iI
coNIReL_iD COPY vB
A Document No.: Tide: QualitY Format for I>rue Release Report for S3rolirnus aut:rIg } Department: i
1QF/Qca 11 Coron&ry Stent/Stent System
q••mInI
! Quality Controt
=uh•FaFnd
!
C. Observation Table 3: .
Wt. After Difference in

Sample S No. Initial Surface
Analysis (mg) Weight (mg)
22oSo03H -o%+ Iq lg .2/g a_okd Clea2
Total i Total Total Total

Total Drug
Release Release Release Release
Sample S No. Recovery
after 1 hr after 2 hrs after 3 hrs after 6 hrs
(%)
(%) (%) (%) (%)
, 2203003 U, Vg IF 61.ny +t.Sg q3 , g/ ge-Co

Li nI it NLT 30% NLT 45% NLT 60% &LT 7-iii NLT 96%
e E. Acceptable Criteria: Specification/Acceptance Criteria for all size as weI! as vessel size as follows:
• Drug Release ntu',t be NLT 30% after 1 hour
• Drug Release must be NL 1 45% after 2 hours
• DruG Retea se must be NI.I GO% after 3 hours
• Drug Release nlust be NH 70% after 6 hours
• The Total Drug Recovery must be NLT 90% after 48 hourb
F. Calculation
-f
Standard Area {Volt) Standard Area {Volt) ! Standard Area (Volt) !
! Drug Standard No.
Day 01 Day 02 1 Day 83
{ SilO:InIt::. Standard No. 1
l__a
aaa &am/J__ _,_. j__.',£zu#_
Sil'f 1:InIt IS Standal rJ F"Jo. 2
I S irc? lirr\IIb Star Id;lrd

\ 6130£3£ _.____\
__61.g3YB2._ ._a2_Jag_e
No 3
"'=_
.._/1_asIa
e i Slrolimus Standard No. 4
i
i Sirolirrlus Standard No. 5
\ b2(3g.
__\___GraM_q
__6\23nt3_,,__,_.
_ __I_Jv_afs
_Z_'tU12___
i Average
ZI.:yah@
___}__£U3JZI.._ag____.___j_ 6L6.Zr_2£lIIg_
: -Sia-iIiiaTi-b;Cia-doi
Ht),pa__j,. .au;_I_n_ ££{4L Ha
[iiiIS-li iIi iThh-hmMT©
_] ___Z_ r/
Standard PPM Standard PPM Standard PPM
i Drug Standard No. Day 01 Day 02 Day 03
[ Siloi:i;luJi£aidiFaM
I Sirolimus Standard No. 2
U
[Slrolirrtt15 Standard No. 3

+UIP•HHln Id ):/3
\ c)I_II __
Sirotlrrtus Starldard No. S
IP],g4_ _ Jo
Average
\_q2=LJ I. £g
Standard Deviation
a, vd YI 1.
m r Ge Than 2.0 %)
__.J
na=•h,•nbqnn••=n ++++
Revision No.: 83 Effective Date: 01.07.202] Page: 2 of 7
a COPY {],:Jrl[]
CONTROI.LED <a p : { :nlI}}J I:
a
Document No.: Xiii–diii;; il FiFA ioTJFi-i-ia;;i;iT;;J;iTifaFai=;"iT;;iii-g-–"-}--i;'&;;iii;I
! aF/QC011 f.,fIna,y }tent/Stent System _ ..„„ !C!„elity Control ,,i
':' For 30 Minute Sample: .

i Drug in ppm = Sample Area X Me,;n SToLdrd PPM
Mean Standard Area

-'----'I
\
:,______.__
__.___
,_ _73432 1 _ Y )aZ.))
. .__613_ga„.Z!!Jq!
_:.__._
i
; :/ /) , gS
i Drug in Pg (Actual Result (Pg)) at 30 rr in.= Drug in ppm X Quantity of(methanoi + HP)
A,gS xl
F
'- lin.sg
Cumulative Alnount for 30 rnin. = Drug in HE (Actual Result {pg)) at 30 min.
., PH, Kg
e Si Cumulative for 30 min. = CumulatIve Amount for 30 rnin X 1(Jfi
Theoretic,at Drug Amollr,t (Pg)
I- /tR,si )\03,2538 X /da

;/ HZ'33
For 1 Hour Sample: -
Drug in op in - Sample Area K Mean Standara PPM
Standard Arc,a
b.nearI
J)3 )Hag _ X/d/ J)

£133973.g e_
/
2.32
Drug in FIg {At ttl01 R=’suit {pC}} at ! tlr, OlliE iI> i IF:n X Quantity of {me:hatlo! + HP)
, z.sat q
e Za. 1/
Cul;tIiati vc A!'. ;’_ tlr it ii>-{ h ;;' ;'C:'ruE in-;1;; { Art';ai Af.;suit {FC)} a{ ’ii i;ii i:, I b6 irl }:g { A': \ual Rest;It !' bill-;i-1- A;
' PP
PH.43 + 2d. v
,, £D. 4\
; i Cliilu:£tiJe for ] Hr: i CLlriili it iCe A1 TtaJi’. frir ]'lir J -X-1 dJ
TheoretIcal Drug Amount (pg}
!, ;/ 2d}:L 3 : ;T: y /I a
I
!
'/ dI.H'/

JP f-icS;FIO
F„ef= {::'1-{": :" r.( IP\{
TROL!„ED COPY
I Document No.: 1 Title: Quality Format for Drug Release Report for Sirolimus Eluting -bib;;;iT;;---']
BF/QCOI:1 : Coronary Stent/Stent System Quality Control
':' For 2 Hour Sample: .

: Drug in ppm = Sample ABa X Mean Standard PPM
Mean Standard Area
_)33H4{ _ X jaI,. )I
f_13_lg_23..o’ ' -- '
L
' 2. ZS
; Drug in pg (Actual Result (pg)) at 2 Hr.; Drug in ppm X Quantity of (methanol + HP)
i
i
r
//3X g'
> 1g. o'
' ___
_..I
!-i bTilIJiii-X-iii dil-+;i} iii: :fu it;ul£{i; An-iii-, it -}if i hr --} bri;i IFt big liE;LaT ie-i ui;-i-L;)}- iI-}. --AI:
e ;- q2. //
dH. 4) + \qr a'
•n••n=n=••p + r•r = =Un•p=U•p =n=n••neHrU n •= = =n•r•nn = +=nUnn = •==• = n • r • • • r Urn rn• mn • = =+ n r=+P nP P pPP ren nrr HaHnHarT ==+ = n UPPer= r==n nUnn=n
nP=rr neHIU=rUn ==FqHF= S= n == W an
' % Cllmulative for 2Hr. = Cumulative Amount for 2Hr X 100

Theoretical DI ug Amount (pg
a
/’ X Ida
ii
r
(
-lz7#;'
lg.32
For 3 Hour Sample?-
Di ug in ppm = Sali}pIQ . Area i Mean Sia;ii-a-I J bPM
Mean Standard Area
[
++P
rJ;TL,; X )OZ )J
d. 3g
e } Drug in Pg (Actual Result (Pg)) at 3 Hr.= Dr'IR in ppm X Quantity of (methanol + HP)
:- O.3g I i
) n. la
Cumul£t i \;e A;riJii7aF–3–AT, ; Ed; C--E{i;iibibtTFfi GiliF.-- i-ii-it;£'G--iii- A&l ILI ifisu Il(iii)} it i Hr .
PP
'12.+1+ A112
> g4. IV
% Cumulative for 3Hr. ; Cumulative Amount for 3Hr. X ] 00
i
Theoretical Drug Amount {Hg) .J
):p r:Tg I? X )r L d
g3.d+
Revision No.: 03 Effective Date: 01-07-202 1 Page: 4 of 7

JP
CONTROL-L=DCOPY [lana re :. T'?"r --: C.o'::':

hub hunan
b Document No.: 1 Title: quality Format for Drug Reiease Report for Sirolimus Eluting ! Department: i
QF/QC011 1 Coronary Stent/Stent Sysn,m , ,, I Qua!!entd
+:+ For 6 Hour Sample: -
Sample Area X Mean Standard PPM
i Drug in ppm -
Mean Standard Area
B
,/
//20
'zn,„, x 1'7' Ii
ft++
0. 10
Diug’ in [i'd-
TAEhiTFGs-ilaibij-;i-E-HI.;-i)Tubi- iF;-r-i -I-i;-ii}BiT;iIL;iii -; -FiFj
’- o. \' i IJ
'- O. no
Cumulative Amount for 6 Hr. ; Cumulative Amount for 3 Hr, t Drug it1 Pg (ActuatResutt-k-a-E–j} -iii aT
', Vt.}+3 + o-no

e aPH-
%4 . Kg
% Cumulative far iN i.-:(: J'i;-Lili;it/i-ii;iII-r+; -Fir--dNI.-'- i {bci
Theoretical Drug Amount (pg)
/ ={11: :a ? Y /a a
pr
73 . IU
':' For 24 Hour Sample: -
Dr liE in pprn = $lrp de 'Arpa X Mean Standa-ra' iP-$
Mean Standard Area
I Y/a-a
o. aZ
e Diug irl IIi-{X;tL£l ki;lit–(iii ji-it -b;fIIF- I-bFi;b i-i-j;pFil-I-dJ:;-iii&-a };iIihi-iII Ill-FI
"'„/ t d
zZ, 6/ g
Currlularive Amount for 24 Hr. = Curnuiative Amount for 6 Hr. + Drug in Hg iActu'-,I Result (pg}} at 24 Hr
i
, (4.gjl–„'. t
;- v4.g I
} -k-C-C;;it; F£'iiJ;'t;i-2ahT:-;-iJ;+iili£lic&’IFr;;;[IF,ifi;i }aHl: -- I !fail
Theoretical Drug Amount (pg)
===–'
/23
XJro
/
Id5.g53Y
% 3 .gz
a•n•n•un•HIHa•Pbn•l•lf
anFnJi=n•RIn
Revision No.: 03 Effective Date: 01-07-2021 Page: 5 nf 7

CONTROL.LED COPY - plano y I /F-iV+
;.qI-[; '-., ,„ 'I..f-$ {'-1,V
L... , ' . ';;ppd pF 7
I
i Document No. :
QF/QCOll
Title: Quality Format lor Drug Release Report for Sirolimus Eluting
$oronary Stent/Stent System
j Department:
! quality Control
':' For 48 Hour Sample: -

Drug in ppm = Sample Area X Mean Standard PPM
Mean Standard Area
+
n=1+
Pa
aX lo2' ;B I
o, a I i
-1
Drug in pg (Actual Result (Pg)) at 48 Hr. = Drug in ppm X Quantity of (methanol + HP)
[-
i
d, el })
I
'/ d, aH
: CumuiaTivc Amount fo:- 48 Hr. = Curl,ulative Amount for 24 Hr. + Drug in pg {A£hi3–1-iii-iia- iii} i it- aB–iF
I
e g+ .3 1 # b.a-A
,_ 44, Lg
'iI-dJ rr;ii£iiJ-i- iiiIiHF: : tiM-Cli-a'ii:'–e-X;;;iii;i-+;;-i iii i XI '.)0
{heoretical Drug- Am-tIC,Tit–(1:i)
i
,gl,33 _ X 1,,
) dS. 253 (
f3 .32
For Total Drug Recovery after 48 hr. Sample: -
! Drug in pp)nl ' 5arUpIp ra eq X F/ie3nScdr'Jald PPM
Mean Standard Area
})12H3 d
dPP+ --––---–---n X / d/ }Lg
i) 62Y2 f. no
;- /1 rd
e (Actual Result (Pg)} Drug in pg at T'o taI Drug Hero\'er\; afTer 48 hrs.= Drug in ppm X Quantity of {metharIO}}
I
6.td x
'- 13 12
in m Jtati \;e Al noc nt far lot-ai- Drug Hero'S'oF\,- :Ihl i4£ }:r;-I- ; CL;nlCi;;-;:., ;' iI;I: Ill;-t f-or-l8- H /–-i-licIt::I ; hL;Iii; i-'Iii]]
!:>!'uR in Pg al -Fatal Drug Recovery ;-) it' r 48 hrs.
,+PP gT,as + \3, 42
'- lol.84
!% Cumulative for Total DrUg Recovery after 48 hr. = gLUIUL biNg Amount&T£Lat Drug Recovery afte[ 48 hrs, X 100
[heoretlcal Drug Amount (pg)
I
'\lf-,{La.X lao
i AC. ro I
Revision No.: 03 Effective Date: al-07-2021 Page: 6 of 7

COPY rii3rID
CONTRGL:..ED T ) t; f +:: ::++\:
f f r/\ {'- {) i::t\
p
'n-"''l
+
Document No.: i Title: Quality Format for Drug Release Report for Sirotimus Eluting [Departrtent :
I
1QF/QCOll Coronary Stent/Stent System i Quality Control l••M•,al
!
Conclusion: - The sample coFhplies / does not corrIpl,/ 83 per ,ppc;fication
Reference: - QTM/FP002
Analysis By: ReviewedBY. ) eq) ot< Approved By
Sign Sign: ;) I) J ’+ SIgn
Date
D,:.: I >-tK- M22- Date
Abbreviation: -
Micro gram
Milli Gram
MeoH
hr,
Methanol
HOUr
I
Parts Per Million No Number
Serial Number min Minute
6 Standard
Not Less Than

HP-P-CD
RSD
<2-Hydroxy Propyl)- E - Cyclo'dextr}ne
Relative Sta;ld3rd Deaa;Foi
=n•gInnq•rUM=n+ ===den==••• =
Revision No.: 03 Effective Date: 01-07-2021 Page, 7 of 7

1+
NANO THERAPEUTICS PVT.LTD

System ConfiguratIon
<<Instrument>>
Sample Information
Sample Name ; Blank MeoH-
Sample ID : Blank
Tray# 3
Vial# l
Method File : Nano-1(Sirolimus Loading & Release).tcm
Date Acquired : 5/10/2022 9:51:08 AM
Chromatogram
mV
I Detector A 276
5.0 7.5 10.0 12.5 5.0 17.5 20.0

min
Peak Table Blank MeoH-lO-05-2022-01.lcd
Si,n: _>pdd
Date:10-05-2022 Date:10-05-2022
1/ 1
<<Instrument>>
Sample Information
Sample ID : Blank
Batch File : Loading & Release .tcb
Tray# 3
Vial# 1
Date Acquired : 5/10/2022 10:11:27 AM
Chromatogram
mV
1 Detector A 27
0.0 5.0 10.0 12.5 15.0 17.5 20.0

min
ma Hr
e Peak# Name Ret. Time Area Area% Conc. mr
Tota
Sign:
_D) pct el
Date: 10-05-2022 Date: 10-05-2022
1/ 1
+
<<Instrument>>
Sample Information
Sample Name ; Sirolimus Std. 10C)ppm-
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 10:37:47 AM
Chromatogram
mV
1 Detector A 276n
E
151
I
E
125-
i
g
100-
\
75-
/
g
6
5a /
\
d
/
3
E
25]
/
/
\
I
tE
0
/'\
0.0 2.5 5.0 7.5 1 0.0 12.5 15.0 17.5 20.0

min
e Peak#
1
Name
Sirolimus B-lsomer
2 Sirolimus C-lsomer
Ret. Time
12.25
15.44
Area
6186099
257346
Area%
mm1
3.99
Conc.
0.00
r
Im
Im
a
1.11
1.04
i4708
31860
Tota 6443445 mmI
„,., )DFtel
Date:10-05-2022 Date: 10-05-2022
1/1
<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Method File ; Nano-l(Sirolimus Loading & Release).Icm
Date Acquired : 5/10/2022 10:58:06 AM
Chromatogram
mV
1 Detector A 27
rrllrl
Peak Table Sirolimus Std. 10C)ppm-10-05-2022-02.lcd
e P e;k#
1
2
Name
Sirolimus B-lsomer
Sirolimus C-lsomer
Ret. Time
12.31
15.54
Area
6130836
255501
Area% Conc. Unit
96.00 101.96
4.00 0.00
Fm
m
leoretical Pla' ’meter(USP
14657
32201
Tota 6386337 100.00 101.96
Analysis By: Mittal Patel Reviewed By:Deepak Pate
Si,n: Dbp4al
Date:10-05-2022 Date: 10-05-2022
1 /1
<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Injection Volume 20
Date Acquired : 5/10/2022 11:18:24 AM
1 Detector A 276n

Dete
e Peak#
1
I
Name
=
Ret. Time
12.38
15.63
6114599
254219
Area% Conc
96.01 101.69
3.99 0.00
Unit
rn
Im
lretical Plates/meter(USP
14605
32188
Tota 6368819 100.00 101.69
Sign:
y>)> p#4C
Date: 10-05-2022 Date: 10-05-2022
1/ 1
<<Instrument>>
Sample Information
Sample Name : Blank MeoH + HP-
Sample ID : Blank
Data File : Blank MeoH + HP-10-05-2022-01.lcd
Tray# 3
Vial# 7
Date Acquired : 5/10/2022 12:59:56 PM
Chromatogram
mV
1 Detector A 276nr
e 3
a
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0
Peak Table Blank MeoH + HP-10-05-2022-01.lcd
e Fe;k# Ret. Time Area Area% Conc r a 'meter{USP
Si,n: )bp'tel
Date:10-05-2022 Date:10-05-2022
1 /1
+
a
I
<<Instrument>>
Sample Information
Sample ID : Blank
Tray# 3
Vial# 7
Injection Volume 20
Date Acquired : 5/10/2022 1:20:14 PM
1 Detector A 276n
Sign
Si,n: ,i)V p+el
Date:10-05-2022 Date:10-05-2022
1/ 1
IS
q
X
<<Instrument>>
Sample Information
Sample Name : SECS Release Sample-
Data File : 22050034-087-10RPM-30 min-.lcd
Tray# 3
Vial# 11
Date Acquired : 5/10/2022 2:41:30 PM
Chronlatogranr
uV
1 Detector A 276n
e 7500
5000
2500
a
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0
min
Peak Table 22050034-087-10RPM-30 min-.lcd

Detector 27611
Peak# Nam8 Ret. Time Area Cmrl leoretical Plat 'meter{USP
I I slMm& 12.32 297521 93.96 4.95 m 1.13 16664
i[$iolibhmm 15.50 19130 6.04 0.00 rn 1.00 37892
Tota 316651 loo.o6 4.96
Sign: a,>p'tel
Date:10-05-2022 Date:10-05-2022
X
<<Instrument>>
Instrument Name ; C}C-HPLC-002
Sample Information
Data File : 22050034-087-10RPM-1 Hr-.lcd
Tray# 3
Vial# : 15
Date Acquired : 5/10/2022 4:05:22 PM
Chromatogram
mV
1 Detector A 276n
4-
e I
31
It
2- 11 C)
\
E
a
I
d
1-
P S
E
I
tB
+-J T
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0
min
Peak Table 22050034-087-10 RPM-1 Hr-.lcd

[
Fe££# Name Ret. Time Area Area% Conc. r a

I 12.31 151408 94.25 2.52 bm 1.13 i6659
mI 15.45 9243 5.75 0.00 Im 1.07 38102
Tota 160651 100.00 2.52
Sign: Dl,path
Date: 10-05-2022 Date: 10-05-2022
IB
<<Instrument>>
Sample Information
Sample ID ; Sirolimus Drug-
Data File : 22050034-087-10 RPM-2 Hr-.lcd
Tray# 3
Vial# ; 19
Date Acquired : 5/10/2022 5:34:28 PM
Chromatogram
mV
1 Detector A 276n
e 3
0.0 2.5 5-0 7.5 10.0 12.5 15.0 17.5 20.0

min
Peak Table 22050034-087-10RPM-2 Hr-.lcd
fe;kI
e I
I
Name Ret. Time
12.37
15.57
Area
135497
9442
Area% Conc. r
93.49
6.51
2.25
0.00
rrl
Im
1.13
0.98
eoretical Plates/meter(USP
i6956
37761
Tota 144939 100.00 2.25
S„n:-3DP44Z
Date:10-05-2022 Date: 10-05-2022
&
\ Be

<<Instrument>>
Sample Information
Tray# 3
Vial# 23
Date Acquired : 5/10/2022 6:55:38 PM
1 Detector A 276n
20.0
rnlri
b; k# Name Ret. Time r

e I
I
12.30
15.48
Area
35308
3618
Area%
90.71
9.29
Conc.
0.59
0.00
Im
Im
1.15
1.07
leoretical Plat Fmeter(USP
16638
38967
Tota 38926 100.00 0.59
Sign: at>pdel
Date:10-05-2022 Date:10-05-2022
V
<<Instrument>>
Sample Information
Sample Name ; SECS Release Sample-
Tray# 3
Vial# 27
Date Acquired : 5/10/2022 8:16:49 PM
Chronratogram
in V
I Detector A 276
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0
Fbi:# Name Ret. Time Area Area% Conc Dr Rl Facta

nsMlb Pa
12.31 612d 91.79 0, 10 Im 0.98 17476
I 15.43 547 8.21 0.00 Im 1.00 105204
Tota 6667 100.00 0.10
nalysis By: Mittal Patel Reviewed By:Deepak Patel
Sign: 31,pd'L
'Date: 10-05-2022 Date: 10-05-2022
NANO THERAPEUTICS PVT.LTD.
k<Instrument>>
Sample Information
FAcquired by ; Mittal Patel
;Sample Name : Sirolimus Std. 100ppm-
Tray# 3
Vial# 2
Method File : Nano-1(Sirolirhus Loading & Release).Icm
Date Acquired : 5/10/2022 8:37:06 PM
Chromatogram
mV
1 Detector A 27
rnlrl

Detect
r
e Pdak# Name
Sirolimus B-lsomer
2 Sirolimus C-lsomer
Ret. Time
12.18
15.34
19
2
a
3
ml
Unit a
bm
m
1.13
1.02
r(USP
i4960
32364
Tata mal m1
lysis By: Mittal Patel Reviewed By:Deepak Patel
Sign :
I)DP'tcl
e:10-05-2022 Date: 10-05-2022
b

<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Date Acquired : 5/10/2022 8:57:24 PM
Chromatogram
mV
1 Detector A 276
min

a A ?7f;nm
P8akt NaM ire Unit a
e Ret. Time eo
Sirolimus B-lsomer 12.17 mq9 nl 1.13 1

Sirolimus C-lsomer 15.33 2 3 1
Total monD1
nalysis By: Mittal Patel Reviewed By:Deepak Patel
;*„-.nP#'
ate: 10-05-2022 Date: 10-05-2022
1/ 1
'3

V
:<Instrument>>
Sample Information
Sample ID : Blank
Tray# 3
Vial# 1
Date Acquired : 5/11/2022 7:29:39 AM
Chromatogram
mV
1 Detector A 276n
e 0.75–
0.5
0.25
0.00–
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min
eA
pe+ect9
NarAi Ret. TiM Area Area% Conc. m ilini ma eorc USP
,nalysis By: Mittal Patel Reviewed By:Deepak Patel
Sign:
J,I,pet cl
ate:11-05-2022 Date:11-05-2022
1 /1
\1

<<Instrument>>
Sample Information
Sample ID ; Blank
Tray# 3
Vial# 1
Date Acquired : 5/11/2022 7:49:58 AM
Chromatogram
mV
1 Detector A 276n
a 0.75
I
0.50
0.25
0.
–––-__
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0

min

[
nr
e Peak#
Tata
Ret. Time r WI o
'„: a&pq&l
Date:11-05-2022 Date:11-05-2022
1/1
NIL

<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Date Acquired : 5/11/2022 8:10:17 AM
Chromatogram
mV
1 Detector A 276n
a ]5a n g
125-
/
f
g
10
75-
I
50-
/
25
0-
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0

min

Det! In
e Peak#
I
I
Name Ret. Time
12.17
15.32
Area
6239894
256991
Area%
9
3.96
Conc
0.00
r
Im
Im
1.13
1.02
leoretical Plat 'meter{USP
14943
32972
Tota 6496884 mnolM%
Sign:
DE,pd(L
Date:11-05-2022 Date:11-05-2022
1/ 1
<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Date Acquired : 5/11/2022 8:30:35 AM
Detector A 276n

Detect
mailing Facto
e Peak#
1
2
Nar;Ii
Sirolimus B-lsomer
Sirolimus C-lsomer
Ret. Time
11.84
14.87
Area
6199842
259706
Area%
mil-m
4.02 0.00
Conc.
m
m
1.13
1.02
’meter(USP
14889
31945
Tota 6459548 mnoldib
Sign Sign :
aDVaac
Date:11-05-2022 Date: 11-05-2022
1 /1
++
+
<<Instrument>>
Instrument Name : QC-HP LC-002
Sample Information
Project Name ; RM & FP Analysis
Tray# 3
Vial# 2
Date Acquired : 5/11/2022 8:50:53 AM
Chromatogram
mV
1 Detector A 27
rnln
Peak Table Siroltmus Std. 100ppm-11-05-2022-03.lcd

Detect 2
Ret. Time r
e Peak# Name Area Area% Conc. eoretical Plates/meter(USP
I 11.62 6185855 mal 0.00
Im
m
1.14
1.04
14410
31339
l 14.61 264832 4.11
Tota 6450687 mo m1
Sign:
D>rtel
Date:11-05-2022 Date:11-05-2022
1/ 1
-q
+
<<Instrument>>
Sample Information
Sample ID : Blank
TraY# 3
Vial# 7
Date Acquired : 5/11/2022 9:11:11 AM
Chromatogram
mV
1 Detector A 276n
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min
Feak# Ret. Time Area Area% Conc r retical Plat1 'meterfUSP

Tota
*"W
Date:11-05-2022
Sign:
I,bp+'L
Date: 11-05-2022
1/ 1
lqr
<<Instrument>>
Sample Information
Sample ID ; Blank
TraY# 3
Vial# 7
Date Acquired : 5/11/2022 9:31:29 AM
Chromatogram
mV
1 Detector A 276n
3 I
2.5
2.0–
1.5
\
1.0-
0.5-
0.0-
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min
Name Ret. Time r a
Sign Sign:
)b p+d
Date: 11-05-2022 Date: 11-05-2022
1 /1
hI

\r
<<Instrument>>
Sample Information
Tray# 3
Vial# : 31
Date Acquired : 5/11/2022 10:52:40 AM
Chromatogram
1 Detector A 276
Fe£k# Name Ret. Time Area Area% O rl leoretical Pl 'meter(USP

I 11.77 1342 100.00 0.02 rn 1.09 16859
Tota 1342 100.00 0.02
Sign: ni,FF'L
Date:11-05-2022 Date:11-05-2022
<<Instrument>>
Sample Information
Sample Name : Sirolimus Std. IOC)ppm-
Tray# 3
Vial# 2
Date Acquired : 5/11/2022 11:12:58 AM
Chromatogram
mV
1 Detector A 276n
0.0 2.5 5.0 7.5 1 0.0 12.5 15.0 17.5 20.0

min

Detect. n
Peak# Name Ret. Time Area Area% o retica I Plates/meter(USP
B-Foi 11.67 6119785 96.07 Blm); 14569
–2]EMiim-riei 14.68 250l31 3.93 0.00 Im 32187
Tota 6369920 100.00 101.78
”,„,JDp4&
Date:11-05-2022 Date: 11-05-2022
1/ 1
'q
IF
<<Instrument>>
Sample InformatIon
Data File ; Sirolimus Std. 10C}ppm-11-05-2022-05.lcd
Tray# 3
Vial# 2
Date Acquired : 5/11/2022 11:33:16 AM
1 Detector A 276n
Peak Table Sirolimus Std. 10C)ppm-11-05-2022-05.lcd

B
Fe;k# Name Ret. Time Area Area% Conc. Unit Tailin a ’meter(USP
e I
-2ls
11.68
14.69
6116450
251724
96.05 101.72
3.95 0.00
Im
Pm
1.14
1.03
14560
31983
Tota 6368173 Tootoo 101.72
;-': -bhp't 'L

Date:11-05-2022 Date: 11-05-2022
1/ 1
<<Instrument>>
Sample Information
Sample ID : Blank
Batch File ; Loading & Release .lcb
Tray# 3
Vial# 1
Date Acquired : 5/12/2022 7:30:12 AM
Chromatogram
mV
1 Detector A 276nr
I
e 0.75
O.5a
0.25
0.00–
-0.25-
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0
min

Detector A276nm
Peak# Name Ret. Time Area% Dr Wo
e Tota
Sign: =BF4tl
Date:12-05-2022 Date:12-05-2022
t:.
V
V
<<Instrument>>
Sample Information
Sample ID : Blank
Tray# 3
Vial# 1
Date Acquired : 5/12/2022 7:50:31 AM
Chromatogram
mV
1 Detector A 276n
h
e 0.75
0.50
0.25
0.0 a
\–––,_-,--
-0.25-
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min

E
Pea Fa Name Ret. Time r mr al I leoretical Plates/meter(USP
e Tota
Sign: JD/446
Date: 12-05-2022 Date: 12-05-2022
q

$
<<Instrument>>
Sample Information
Sample Name : Sirolimus Std. IOC)ppm-
Tray# 3
Vial# 2
Date Acquired : 5/12/2022 8:10:49 AM
Detector A 276n

cia
Peak# Name Area Area% Conc r eoretical Plates/meterf USP
I 6213542 nHl Im 1.13 i5273
I 254970 3.94 0.00 Inl 1.02 33497
mo 6468512 l
DDp4&c
*":#
Date: 12-05-2022
Sign:
Date: 12-05-2022
S
i
lb
<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Injection Volume 20
Date Acquired : 5/12/2022 8:31:08 AM
Chromatogram
mV
T) I Detector A 276n
l
150-
e 125
75
50
/\
I
/\
25
/
\-
/
hI- in
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0
Pe; k# Name Ret. Time Area Conc. r ’meterfUSP

8
Area'> a
1 Sirolimus B-lsomer 12.38 6216970 9 Im 1.13 14810

2 Sirolimus C-lsomer 15.58 261669 4.04 0.00 Im 1.05 32467
Tota 6478639 mm1
Sign Sign: ?))pda

Date:12-05-2022 Date:12-05-2022
IP
<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Date Acquired : 5/12/2022 8:51:26 AM
Chromatogram
mV
1 Detector A 276nr
150–
e 125
100
75
25
0.0 2.5 5.0 7.5 10.0 1 2.5 15.0 17.5 20.0

min
o rm
8
Peak# Name Ret. Time Area Area% a ’meter(USP
1 1Sirolimus B-lsomer 12.31 6210556 9 Im 1.13 14795
I 15.48 255402 3.95 0.00 IIla 1.02 32610
Tota 6465957 mm1
Sign : DDP4el
Date:12-05-2022 Date:12-05-2022
A
b1ra+
NANO THERAPEUTICS PVT.LTD . J
<<Instrument>>
Sample Information
Sample Name ; Blank MeoH + HP-
Sample ID : Blank
Tray# 3
Viat# 7
Injection Volume 20
Date Acquired : 5/12/2022 9:11:44 AM
Chromatogram
mV
3
1 Detector A 276nr
2.5
11
2.0
1 .5
1 .0
\\h
0.5-
0.a
0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0

min
Feat;it Name Ret. Time Area% mrmI Mr no

@ Total
Sign: MP(+d_
Date:12-05-2022 Date: 12-05-2022
T)
Ye
<<Instrument>>
Sample Information
Sample Name ; Blank MeoH + HP-
Sample ID : Blank
Tray# 3
Vial# 7
Date Acquired : 5/12/2022 9:32:02 AM
mV
Detector A 276n
@ 4
====n
0.0 7.5 10.0 2.5 5.0 7.5 20.0

ct
Peak# Area Area% mr WI
8
Conc. o
Tot;
Sign Sign: DDp4LL

Date:12-05-2022 Date: 12-05-2022
<<Instrument>>
Instrument 'Name : QC-HPLC-002
Sample Information
Data File : 22050034-087-10 RPM-48 Hr-.lcd
Tray# 3
Vial# 35
Date Acquired : 5/12/2022 10:53:12 AM
Chromatogram
1 Detector A 276n

netect
Peak# Ret. Time Area Area% Conc mr a
@ I
Tota
12.18 457
457
100.00
100.00
0.01
0.01
Im 0.88 32741
Sign: 3,Dpqcl
Date:12-05-2022 Date:12-05-2022
IP
<<Instrument>>
Sample Information
Data File : 22050034-087-Dissolve-.lcd
Tray# 3
Vial# : 39
Date Acquired : 5/12/2022 12:14:25 PM
1 Detector A 276n
Peak Table 22050034-087-Dissolve-.lcd
Peak# Name Ret. Time Area Area% Conc eoretical Plates/meter(USP

6 1
2
Sirolimus B-lsomer
Sirolimus C-lsomer
11.99
15.05
412430
15227
96.44
3.56
6.86
0.00
15181
32509
Tota 427657 100.00 6.86
Sign: )bp4LL
Date: 12-05-2022 Date:12-05-2022
<<Instrument>>
Sample Information
Project Name ; RM & FP Analysis
Tray# 3
Vial# 2
Date Acquired : 5/12/2022 12:34:42 PM
Chromatogram
mV
1 Detector A 276n
min
Peak Table Sirolirnus Std. 100ppm-12-05-2022-04.lcd

IIin
P'eak# Name Ret. Time Area Area% Conc r a ’meter{USP
nlo 12.01 6091472 9 m 1.12 14942
I 15.08 251284 3.96 0.00 Im 1.04 32844
6342756 mmI
S\En..DP+&
Date:12-05-2022 Date:12-05-2022
44

<<Instrument>>
Sample Information
Tray# 3
Vial# 2
Date Acquired : 5/12/2022 12:55:01 PM
Chromatogram
mV
1 Detector A 276
F–-–
15.0
min
Peak Table Sirolimus Std. 100ppm-12-05-2022-OS.lcd
e
Peak it Name Ret. Time Area Area% O leoretical Plates/meter(USP
I 12.02 6081592 96.04 101.14 14892
I 15.11 250588 3.96 0.00 Im 32704
Tota 6332180 100.00 101.14
Sign: ')brt d
Date:12-05-2022 Date:12-05-2022
8 8 g 8
PbAn#iLUn CP/,
PIano
CONTROLLEDCOPY M;\ ST== COPY
Document No Department
QF/QCMO02 Title: Quality Format for sterility testing of finished product Quality Control
Microbiology
Product Name
Ma tI r
Batch No. / Lot No ie of Testing
a }a
Date of Report: Analysis Report No.
b PC'6' C
Q-> at f-o
Manufacturing Date Expiry Date la
Media detail
Media Name & Lot No Incubation Condition incubator I.D. No Reference Culture
R
Pch.B6£D- oo
e Observation:
Product Identification No.
Date 3G>n F ()
Signature
Positive Negative FTGM Positive Negative SCDM
Control Control Growth Control Control Growth
yI
KG
C
;
r 7pFg
Z IJ
a,2 PZ
:+
+'
$$
6 a
Abbreviation: “-Ve": No Growth, “+Ve": Growth, “-": Negative Control, “+”: Positive Control, “H": Holiday,
FTGM: Fluid Thioglycollate Medium, SCDM: Soybean Casein Digest Medium
I
Result: The test of sterility corrfblies / does not comply with the test result as per the in-house test method
QTM/QCMFPO02.
Analysis By: Reviewed By

t\\, a>eq>op- 4>chet
Sign
Date
Sign
Date
S)nl
DV-crJ'-->d &2--

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CONTROLLED

Date of Report Ana:ysis Report No rl

BaD 'q3 lILQB_=Zda

:asa tC Se'’is,tiT 7: -.'

I. a' 3+.O'G =,HI

CSE (Pi} LAL Reagent (+!} ; ,-;b$ervatien !

Analysis By Reviewed By: e \at el

Revision No.: 03 Effective Date: 0142-2022 Page: 1 of 1

PrQduct Name: allO/ih,Inr Flu+i ' rl

Analysis Report No.: /UrAl \a& l__IA.

! Residual Ethylene Chtorohvdrine = Limit N.M. T 25 ppm

; PI'c!}Jar cd By Revi. Apprf.,vcd By

Revisit.+n Nap ' OZ Effect iTC T)atc: (•l-lO'20;iQ Page: 1. o! I

Certificate Issued To : NANO THERAPEUTICS Pvr.LTD

1. Name Of Sample : Sirolimus Eluting Coronary Stent System 2. Batch No : 22080016

3. Date Of Manufacture : 09-05-2022 4. Date Of Expiry : 2024-05-08

: 01 NOS 6. Batch Size : NM

Ethylene Glycol Not Detected

Ethylene Chlorohydrine Not Detected

'-' END OF REPORT 'm

Note : Party asked for above tests only.

Note : 1. Sample not drawn by us.

2. Sample will be destroyed after testing. •?:l:}I

0.0 4.0 7.999 (min) 1 1 .999 15.999 19.998

Numb e r Retention Time Area Area % Component Name

9.528 206431900 100.000 Di 1 ue nt

Analysed By:- $$DUO Checked By:

Numb e r Retention Time Area Area % Component Name

2.278 2116 0.001 E TO

Analysed By:- bJtAi0 Checked By: ),r–

0.0 7.999 (min) 1 1 .999 15.999 19.998

Peak Number Retention Time Area Area % Component Name

Analysed By:- KOgAn\3 Checked By:

0.0 4.0 7.999 (min) 11 .999 15.999 19.998

Number Retention Time Area Area % Component Name

9.637 233836800 100.000 Diluen t

Analysed WU\al) Checked By:

Date: Analysis Report No: : (9( -IMP - Do gOO 16 -- 6 o )

9:z05D03 6 -dS-} 2 ll . go S 25–. 203 O.',02 1339-413 i t'tG.3.66

Weight of Stent Difference in Amoun: of Drug Drug Loading

220rDO gd -art 2 g. \'tS– 1'l3.',I'IS II? - IS-O

Actual Loading HPI,C Result Drug Uvit

220W'36 -oi-1 ]!! e . 4 gB_5 FaI . 6, lz3 -1

Revision No.: Q2 Effeclive Date: 01-10-2020 Page : 1 of 3

220£oo.3( –on (') \OS- q6.\l o.13

Mean Std. Area = St + N b +• ,td,N

Me'In 6+d . #7eq At051 innaTE+ 74 +41€£i

Mean Std. PPM = Std.No.1+ Std.No.2+ Std.No.3+ Std.No.4+ Std.No.S

DGu3 -IV) Perf) - \ A'IS veg X 302.33

JX£'48 t.. Erpt = 31. zI \

Revision No.: 02 Effective Date: 01.10-2020 Page : 2 of 3

Drug in Fg = Drug in ppm X Quantity of ACN (mI)

Analysis By Reviewed BY: J) el Approved By: b

Revision No.: 02 Effective Date: 01-10-2020 Page: 3 of 3

Peak Table Blank ACN-11-05-2022-01.lcd

Analysis By: Mittal Patel Reviewed By;Deepak Patel

Peak Table Blank ACN-11-05-2022-02.lcd

Analysis By: Mittal Patel Reviewed By:Deepak Patel

Sign: 3)bP del

e 10.0 12.5 7.5 20.0 27.5 30.0

Peak Table Sirolimus Std. 100 ppm-11-05-2022-01.lcd

Peak# Name Ret. Time Area Area% Conc Unit a 'meter{USP

Analysis By: Mittal Patel Reviewed By:Deepak Patel

Peak Table Sirolimus Std. 100 ppm-11-05-2022-02.lcd