Scribd Logo
Upload

Welcome to Scribd!

  • 30 views

    Ilovepdf Merged

    Uploaded by

    Andri aryanata

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content

    You might also like

    Ilovepdf Merged

    Uploaded by

    Andri aryanata
    30 views135 pages

    Original Title

    ilovepdf_merged (92) (1)

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    30 views135 pages

    Ilovepdf Merged

    Uploaded by

    Andri aryanata

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 135
    (nano CONTROLLED COPY : MASTER COPY E aFfaceas Sirolimus Drug, Everolimus Drug & Pactitaxe! Drug aes Olax 2022 SS He 6R-.eebal- 22 ree, Greeny aoe 2 Shag zs avalye Sean Dales oy ps oe [nats twa ates 5 lee [MEO dept. Zoge [PONG gee > Duct case | [ae] Test/Parameter ‘Specification [ Resuh | The Retgation Umea! sivakious/ tverotimus /Poctaxel peak in be assay chromatogram of sample should macch with | (amplr'€s ‘that oftaborstoresstandords Drug Assay Testy | Soimua Orage | Le Limit: 98.0 wr — 102.0% 0/0 a Palio dog Lim: 97.0% - 102.0% wiv Trolins Org Drug impuriiy Test by HP felons oes ee ee feriomeene care \one “10% 13 | DrugeTin test a Inspection Result bat pasces/des not pas. as per Speciation Reference: 6/2008, 5/RMO08 & OS/RINOA0, seem) Le) fag le a RAE S __ |B 0F- 10-303 Radian Nos 62 es Titective bate 1302088 “Paget $ Biocon incon United vn 98 oss Rud econ Cr ‘seein 560 00 Pa 5: 6 2008 708 ronso pese3an2 CERTIFICATE OF ANALYSIS QUALITY ASSURANCE sr ne ct Name: SIROLIMUS _ = Page No. ip te ee jo. __: BS22003723. = Manuficturing Date + September 2022 Quuntity ——0.300kg Date 2 August 2025 AR.No. _:40000366830_ a | Batch retease date = 12/09/2022 In-house Spesification: aes i i a ‘TESTS [ dion Solubility A white 16 offewhite powder. [Freely soluble in Chloraform, Acetone in Acetonitrile. Insoluble in Water. ia C arp Identification — jethanol(on anhydrous basis) 8. By IR Absorption Complies [a The Infrared absorption spectra of the sample } should be concordant with that of standard, b. By HPLC Complies 'b. The retention time of Sirolimus peak in the | Assay chromatogram of sample should matct | with that of standard. c. By Xsray diffraction | Complies c X-ray diffractogram pattern of the simple should complies with characteristic 2 thet: — mk =} == 16.2°, 200°, 20.4° fie optical rotation [a}o"™, in Bataan ash ancl ee ‘ater content (hy KF titration) Residue on ignition Not more than 1.00% wiw [Not more than 100% wie Related substances (by HPLC) | Content of Iscmners Prepared by : (0! Dare: deloalacaa | Nsomer CE NMT5.0% eenet A di tuomer ©). NMT 10% Isomer Pe: NLT 93. Betwwnen 98.0% w/w and 102.0% wi Appreved by BR wh Date: = (ne (Quality Assurance) 9” $ Biocon ocon Limited 2 Homa oad Pec hy Snes 6 10 ke 1a 20028 CERTIFICATE OF ANALYSIS nk ‘QUALITY ASSURANCE vom tom im __| Manufacturing Date :§ 2022 x | Retest H 2025 AR.No. + 40000366830 Batch release date In-house Specification: - ine TESTS ATO Limits detection level | Diethyl ether = NMT 500 ppm Below deteetion level | Acetone NMT 500 ppm Residual solvents (by GC) Below detection level =NMT 50 ppm : Below detection level - NM 50 ppm %. Below detection level + NMT 1000 ppm | 7Mierobial limits ‘Total Acrubic Micrabial count Less than 100 efw/s | Not more than] 000 efit | Total Yeast and Mould count Less than 10 cfug | Not more than100 efuig Escherichia ca Absent Should be absent in ig Salmonella spp Absent Should be absent in |g Staphylococcus aureus Absent Should be absent in Ig Pseudomonas aeruginosn Absent Should be absent in 1g Candida albicans | Abscat Should he absent in |g Clostridinmn spp Absent Should he absent in Ig a fol ar negative bacteria | Absent | Should be absent in |p mg | Not more than 1 EU/mg = sample complies with the ubove tests as per In-house specification. Prepared by: @ Date: Jolog}aoan Approved by : a Date: A (Quality Assurance) lene CONTROLLED copy MASTER COPY a raat iso Se oe SE on ee —— | Mean Std. aren = + Sid Node 5 [et td: Aer TEA PLEO TOTNTF ESET WTO EPR METAS Iman AH freah WARNES Yo (Mean Ste PP sete testa Node Sa Na Sanam SINE _ + Pi | 54. | pencerm 54. porns. 192914 195.204 14, 79 TE SEF BS | | {heen Std Pm > 199. ho Druginpem= Sample ga Mean Stendard PPh Mean Standard Arex 12 Foas HTB )N9.S F2 Diy” ppm 2p 205 60 NI9S Jo Bag 1 ppm Assayin’ = AsiaySample Aiea X Sid Cone ppm) Drug abel Claim Standard) Mean Ste. Ares Mean Sample Cone. ppm) _ MAS, 145.10 Rosy int Tanase * Jes ase thd 1 ATAH X O.9AMSX LB im jolg 7. Xbid Revision Nos 02 Effective Date: 01-10-2020 Pagerietz coNTROLLED COPY «=» SIS MASTER COPY Name of Grog ‘Batch No. I Drug Assay (%) Limit i RS 29003129 M34. 49, 4 =l02. 0 7. Total impurities tomer A, tsomer 8 isomer € (excluding Isomor A be 6) a 5) Btsomer ¢} 6) Srolirie Dea oan | 4v.at | 12? 0.13 Timi Wat 05 % wareson | _AwTsom TMT 50% ar See ie = me : es) i) sine e } See aa Conclusion: ~The sample complies / daes nat cory as pe specification Reference: QS/RM008, QS/RMD09. ‘Analysis By; | Reel [Revewed or Decpor pope ‘Approved 8 Fray duh Coun Sen Sex _Ampyel Sgn Cater 07. )e- 99.27. Date: 07 -40-2422- OF~\be 2882 Revision Wo.-02 Effective Date: 01-10-2020 Page: 20t2 NANO THERAPEUTICS PVT.LTD. System Configuration Instrument Marne Qc HPLC-O02 Sample information ‘Acquired by tal Patel Project Name sarle Name nk CN Data File nk ACN-07-10-2022-01 led Batch File Sirolimus Drug. (8522003723) tea mt ‘viaht Injection Volume ‘Method File lano-3{Sirosimus Impurity. Jem | Date Acauired 10-2022 13:22:37 Ceomogan 02s} =; ‘ae, | Sees on Pameey wo Mo as a ats 300 a w aoe = Toesar AT | so as ess a Hs son = Peale Table Blank ACN-07.20-2022.01 led Detector A 2770m = z= Peakd Nore ie. Time Tiling Factor me] — Area [Area [ cone. [Unit Date:07-10-2022 ‘Reviewed Gy-Deepak Patel ser: popdek ‘Date-07-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration -> Instrument Name = QC-HPLC OG Sample information Acquired by littal Patel, Project Name IM BFP Anahi Sample Name rank ACN Somple iD Blank Data File . Hank ACN-O7-10-2022-02.ted Batch File slimus Drug (B522003723).lcd ‘oe Volt Injection Volume Method File (ano-3(Siralimis Impurity).em Date Acauired 10-2022 14:52:57 oo 25D oo Gs 0 os Ma ms” 250 Peak Table Blank ACN-O7-10-2022-02.ked Ret. Time| area | areas Cone. jee T Analysic By: Metta Patel Reviewed By:Deepak Patel sox: san: poppe Hct cae _ NANO THERAPEUTICS PVT.LTD. system Configuration > Instrument Name =: OC-HPLE-D02 Sample information ‘Acquired by 1 Mita Pate Project Name RM FP Anahyis Sample Narse ! Sirolimus Std. 100 ppen- Sample + Shralimus Drug ata File + Sirolimus S16, 100 ppm-07-10-2027-01 led Batch File + Sirolimus. Drug {8822003723} led Tray 3 Viale uz Injection volume 120 Method Fle + Nano:3{Siofimus Impurity lem Date Acauired 07-30-2022 14:23:18 | oo 35 30S) SS ‘Anabysis By: Mittal Patel Reviewed By: Deepak Patel sex (oy son: popa et ‘Date07-10-2022, Date-07-10-2022 NANO THERAPEUTICS PVT.LTD. < Instrument Name Acquired by Project Name Sample Name ‘Sample 10 Data File Batch File Trey Vial Injection Wolume Method File Date Acquired ‘System Configuration = QCHPLE-002 Sample information Mita ate : RM FP Analysis: # Sirolimus Std. 199 ppm- Sirolimus Orug- Sirolimus Std. 100 ppen-07-10-2072-02.led + Sirolimus Orug (8522003723) ex) a 2 120. + Nano-3{Sirolimus impurity.Jem 7-10-2022 14:53: av 25 sos We 2s se, 30 3 "wo in w a i T TBeicion A Ea Date-07-10-2022 Date-07-10-2022 NANO THERAPEUTICS PVT.LTD. ‘System Configuration Instrument Name 2: O¢HeLC-a02 Sample information ‘Acquired by (Mittal Patel Project Name 1 RM & FP Anais ‘Sample Name i Sirolimus Std, 100 ppm- ‘Sample 10 : # Sirolimus Orv Data File Sirolimus St, 100 pprn-07-10-2022-03 ted Batch File : Sirolimus Orug (8522003723) ed Tray 1B Vial a Injection Volume 120 Method File ! Nano-3lSirolimus impurity). Date Acquired 07-10-2022 15:23:58 | mv t = VDeicior A Fan o Was ns mo ns ea 80 ‘ain Ww 00 : ~ ToeasarA Tia 2 3 4|Unknown '5| Unknown 6 Sirolimus Asem Sirolimus 8-tsomer Siralimus C-isomer 7 8 Total ‘Analysis By: Mital Patel Reviewed By:Deepak Patel Sian: w sen: DOPT et Date-07-10:2022 Date:07-10-2022 ‘System Configuration < Instrument Name Qc HPLe-a02 Sample information Acquired by ‘Mittal Patel : Project Name RM & FP Analysis Sample Narse + p822003723 Sample 10 Sirolimus Deug- Data Fle Sirolimus Drug impurity Testing- es Baten File + Sirolimus Drug (8522003723).icd Tray 8 Viale a Injection volume 20 od Fle no-3(Sitolimus Impurity). Oste Acquired 10-2022 15:54:21 j i AT a al j i i a an 3s ia mo sO SD ‘ain v a — i 000 a0 sone ] } | an a as So us 30 Hs ae i i Peak Table Sirolimus Orug impurity Testing led Detector A272am__ ee ee: - Peak Name et Time] Area | Areas | Conc. | Unit |Taling Factor [Theoret t/a “| Son 23,000) 000) a 2 Unknown, salsa, oe 003 pom tot 3 670,011.54 ppm cer) 4 1.08 5 1.06 9) Laz 35 ‘Analysis By: Mital Patel, ‘Roviewed y Deepak Patel ox (iy san DEPT Date:07-10-2022 ‘ \Date-07-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration ‘eersinenant Instrument Name sacHLc-o02 Sample information ‘eauired by : Atal Patel Project Name ‘RM & FP Analysis: Sample Name ‘Sirolimus Std. 100 pam- Spe Seirus rug Ou ie Sirolimus Std 100 porm07.10-2022-08 Jed Batch File Sirolimus Orug (B522003723).leo it ; va Injection Volume ‘Method File Date Acquired v { ~V Bitecuar A 277m to; | a as se Fs me - i ae = a i Tee A a if i 1] |] At \S\ ds _ CO a a ae = ‘Peak Table Sirolimus Std. 100 ppm-07-10-2022-04 fed Peake Name Ret. Trae Tait [Tlng Focor Theoretical Plates/enete{USR, ae aa Feces cmt 2 Unknawr Toss ee O78) ae 4 tase ta ine a rr Lp ae al 18.32 ippm ar 92664 17.45 {PPM 5883 8) Sirolimus C-isomer 18.88 ippm 224681, ‘Analysis By: Mita Patel freviewed 8y:Deepak Patel sox ( seme DOPF cued 030 oaeorsoa07 NANO THERAPEUTICS PVT.LTD. if fH ul System Configuration - Instrument Name ac-Hpic-o0 Sample Information Acquired by + Mittal Patel Project Name: RM 8c FP Analysis: ‘Sample Name ‘Sirolimus Std. 100 ppm- Sample IO Sirolimus Orug- Data File Sitolienus Std. 100 1-O7-10-2022405.hcd ‘Batch File ‘Sirolimus Orug (8: 1372 3)ted Tray a Viala 2 on Woluere 20 Fite ‘Nano-3(Siralimus:Impurity)..em Date Acquired 10710-2072 16:55:08 av eee j Tose il | | ee = a aso aos OOS MOSS ‘nia w Rimcoeen baat ] | T Beier 7h Bo” Hs” 300 - ia Peak Table Sirolimus Std, 109 ppm-07-10-2022-05.led Aen | Cane. | Unit| [alice Factor. #75555 52621, 90357 l | Analysis By: Meal Patel ot ate:07-10-2022 Datesa7-10-2022 _ NANO THERAPEUTICS PVT.LTD. -- Instrument Name Acquired by Project Name Sample Name Sampie 1D Data Fle Bateh File Tray Viale Injection Volume Method File Date Acquired ‘System Configuration Blank MeoH-06-10-2022-01.led Sirolimus Crug (8522003723). ted a 1 20 Nano-1( Sirolimus Loading & Release} lem 06-10-2022 17:16:25 romp ‘Analysis By: Mittal Patel Date-06-10-2022 Reviewed By:Oeepak Patel sien, pppgel Datei06-10-2022 T Beech Dies _ NANO THERAPEUTICS PVT.LTD. System Configuration | instrument Name sQeHPLC O02 | Sample Information ‘acquired by + Mita Patel Project Name RM BFP Analysis Sample Name Blané MeoH- ‘Sample 1D Blank Data File Blank MeoH-06:10:2022-02 ed Batch Fite ‘Sirolimus Drug (8522003723)-led Tay 3 Vial a Injection Volume 70 Method File :Nano-l{Siolimustoading & Release) Jem Date Acquired 306-210-2022 12:36:47 Chroma 2 ict | oo a so 3 ia 5 180 178 20 ‘Analysis By: Mittal Patel Reviewed By:Deepak Patel Date:06-10-2022 Date:06-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration tnerlnane inde ment Home acspicosa Sample Information ‘Acquired by «Mittal Patel Poles Nate TEMA PP anal Saree Rare Stns 900 pie Stns : Sonus rue Beate "Slims Su 00 pp 06-10-2022.01 ed Batch Fle {Sfots Sroy (8880000725 ed Tot : Viale 2 Metin Volume do ctrod le !Rano-(Stolims oadng& Release Lem Date Aceied ‘ein 2008 135708 _ renee {— =e = 1 Beicctor A278 my 1 2} i = | 9) wo! | é » j ‘ , é By 5 ob i we da ‘Peak Table Seollmus 5. 200 ppm-06-10-2022-01.e8 a aa cia FeTTo [| one [ig Feo Pr ro Skcln Bkcrir | AT T3| 17008) S081| 88 il pem 1000 2/ sirolimus Cosomer | 14.23/ —14i902 aaa: eal [ee See t ‘Analysis By: Mittal Patel Reviewed By Deepak Patel Date:06-10-2022 Date:06-10-2022 ‘System Configuration — ee seiowe sls a ‘cali iit! Project Name AIM & FP Analysis Sample Name + Sirolimus Std. 200 ppm- eee eee Faye perce reer Batch File + Sirolimus Brug (B522003723) ied - : us Z Injection Volume :20 reo Bo iia abliinieadn le as carne s f— | T Daisey A 2 va Ml ew | ia lf “ | | i } | S | $0: | | ; ee a | ow as 30, os ce as do ws mao | ef a eae Ret Time) Area | Area¥ | Conc. | Unit Taling Factor{Theorstical Plaies/meter(USP][ Resolution] USP] i a Sa ee ree a a aoe ea a | a) ae ee “Analysis By: Mital Patel Reviewed By:Cleepak Patel Daves 10-2022 (ate:06-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration instrument» Instrument Name sac-PLc on Sample infarration ‘Acquited by ‘ Mittal Patel Project Name LBM B FP Analysis Sample Name Sirolimus Si, 200 ppm Sample iD Siolimus Orug- Data File Sirolimus Std. 200 ppm-06-10-2022-08 led Batch File Sirolimus Drug (8522003723).ted Tey 3 Yala 2 Injection Volume 20 Method File ‘Nano-1(Siolimus Laading & Release.Jcm Date Acauired 36-10-2022 13:37:52 nw ae f = ae Tae 00} 9 Bid! 5 5 | ‘Sirol inet zs so 15 ioe ms 130 Peak Table Sirolimus Std. 200 ppmm-06-10-2022-03 le Come._[ uni Tatng Factor|heorasealPlates/meter[USP)/Rescluson( US 194.78 ppm | 136) 12736, 4 jure) 08 27776 aw) 100,00, 194-78) T- - ‘Analysis By: Mittal Patel Yevewal BpDsepan patel on OP Sie DEPF Diate:06-10-2022 Date-as-10-2022 Instrument Name Acquired by Project Name Sample Name Sample 1D Data File Batch File NANO THERAPEUTICS PVT.LTD. System Configuration + 0¢-HPLC-002 Sample Information + Mittal Patel ERM & FP Analysis 58522003723, Sirolimus Orug- SE aoe mponee Eons 3 120. :Nano-1(Sirolimus Loading & Relezse}.iem 06-10-2022 13:58:13 x0 rs v0 I i Z 4 be Scene pope ed 0 is 1s 100 us bo vis wo | et Time Peale Table Sirolimus Assay Sample-200 pple a ® fea | ieeai | Gone [ Unt ating Feo Theoret 3] ReivvontUS] 4 Swimus sama | 13s ~aasee083| 9a 79 G0Se8|ppm as ter = Seca Cuamer |14ci]—asteze| —izilaaolggm | i Saar aoa __|__ | 32817569{ "300.00; 208.65) a = - ‘Araiss Oy: Mita Pavel Reviewed By Deepak Pate Daate:06-10-2022 ___ NANO THERAPEUTICS PVT.LTD. System Caotigueation -ccinstrumento> Instroment Nome + QCHPLC-002 Sample information Acquired by ital Patel Project Name IM & FP Analysis Sample Name ‘Sirolimus Std. 200 ppm: Sample 1D "Sirolimus Beuge Data File s Siolimus Std. 200 ppen-06-10-2022-04 led Batch Fle + Sirolimus Drug (8522003723). Trays Viale Injection Volume Method File lano-1(Srofimus Loading & Release).lem Date Acauired 06-10-2072 14:18:37 av ae = TOaear a Taj 0° @) » 20 10 f i an a 30 1s a ds vo sa e r i ae Desk Table Stren St 200 pom -06-10-2072-08 ed [Theoretical Pistes/meter| Us Resolanan(UuSP), 17936, a 3056, ‘System Configuration | <> Instrument Name: += QC-HPLC-002 Sample Information Acquired by + ral Pat Project Name AM & FP Analysis Sample Name Sirolimus Std. 200 pom. ‘Sample ID Sirolimus Orug- Osta Fle Sirolimus St 200 ppry06-10-2022-05 ed Batch File Sirolimus Drug (B522003723).led Tray 3 via 2 Injection Volume: 20 Method File Nane-1{Sirlimos Loading & Release} lem Date Acauired i 06-10-2002 1435.00, av = xo] ee) x! 2x al 100 x} ° 80 as Peak Table Solimus St. 200 ppm-06-10-2022-05 ea 260m. soe es ne — = [feast] Name ot @ |v cctimus mer om eet ‘Analysis fy: Mittal Patel Reviewed By:Deenak Pate! san(y? signs DPT ele Date:06-10-2022 Date:06-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration -> Instrument Name HQCHPLEC-002 Sample infarmation ‘Acquired by Mittal Patel Project Name ERM & FP Analysis ‘Sample Name Blank ACN Sample ID: lank Data File lank ACN-O7-40-2022-01-ed Batch File * Everolimus Drug (B522002284).tcb Tray 3 vial sit Injection Volume 20 Methad File dano-3{Sirolirwus Impurity.Jem Date Acquired £O7-10-2022 13:22:37 ee (Chrarsgeam = Tee ATTA ee fo~ ~~. “=| \/ V so 1S OSS ea oars” soo 20 4) SSD ia Peak Table Blank ACN-07-10-2022-01 led Ne Tine__bes _ Aue Core Tal ‘Talling Factor Theoretical Plates/meter{USP [anti ntl atl anol ‘Date-07-10-2027 |ANO THERAPEUTICS PVT.LTD. ‘System Configuration elnstrument>> Instrument Name + QCHPLE-002 ‘ Sample information ‘acquired by = ital Patel Project Name RM & FP Analysis Sample Name Blank ACN Sample ID Blank DataFile Blank ACN-07-10-2022.02 led Bateh Fle Everolimuis Drug (8522002284) Ieby Traytt 3 Vials nu Injection Volume 20 Method File Nano-3{Sirolienus inpurity) lem Date Acauired 07-10-2022 13:52:57 Chromaogram Teor = r a ; “ | V a as sos SSCS BEL ‘Peak Table Blank ACN-07-10-2022-02 ted Fe eee Ya ‘Analysis By; Mittat Patel Reviewed By:Deepak Patel se (P sox wppgel (Date:07-10-2022 Date-07-10-2022 NANO THERAPEUTICS PVT.LTD. | <> Instrument Name ‘Acquired by Project Nam Sample Name Sample ID Data File Batch File 1 Vial Injection Volume Method File Date Acauired System Configuration Sample Information : Mittal Patel RM & FP Analysis Sirolimus Std, 100 ppm- 2 Sirolimus Drugs Sirolimus Std. 100 ppit07-10-2022-01.ted : Everolimus Drug (8522002284) /eb H #20 +: Nang-3{Sirolimus Impurity).lem, 07-10-2022 14:23:18 nw - = SSeS 3 OOS STS 30. mn Petector A27Inm, Peaks Peak Table Sirolimus Std, 100:ppm-07-10-2022-01.led Name [Ret Time| Area ‘Cone. | Unit | Taiing Factor [Theoretical Platex/meter{USP) 431 0.34) ‘Unknown ‘Unknown. 1.08) ern 1.03) Sirolimus Alsomer O58 Sirolimus B-lsomer 411) Sirolimus C-lsamer 0.95 ‘Analysis By: Mittal Patel oF Date-07-10-2022 aan ear sn DOPE Date:07-10-2022 neh NANO THERAPEUTICS PVT.LTD. System Configuration » Instrument Name =, @C-HPLE-002 ‘Sample Information Acquired by ‘Mital Patel Project Name M&F Analysts ‘Sample Name Sirolimus Std. 100 poe Sampie 10 Solis Drug Dota File + Sirolimus Std. 100 ppm-07-10-2022-60 led Batch File Everolimus Drug (8522002284) cb Tae Vale Injection Volume 30 Method re anol Impurity) em Date Acouires 10-2022 1455:38 ww en | ; | f ] j Tacs A eo” ; iti 1h Wi ° ani = = ———— 0 SCS os mo so as m0 | a - = i Tose AE 0004 li py dei Peak Table Sirolimus Ste. 100 pper-07-10-2022-02 led 325713 125736, 173875, 175789 92309) 8624 eae NANO THERAPEUTICS PVT.LTD. _ System Configuration “> instrument Name sacHPLc-o02 ale information Acquired by > Mittal ae Project Name FAM 8 FP Analysis Sample Name alimus St, 100 ppm- Sample iD alms Brag: Osta Fle olin S100 ppm-07-10:2022.03 ed Batch File Everotimus Drug (8522002284) lets Tray Viale 2 Icon Volare a ‘Method File ‘Nano-3(Sirolimus lmpurity).ien Date Acquired 17-10-2022 18:23:59 ow ey ive] eg area Unknown Sila eae “Systm ‘Secu Ba sos ado 30 ITS a” sa9 ia lw =, 7 soon an Area__| Area | Cone. a 0.01 ood Analysis By: Mittal Patel «Of Date:07-10-2022 Date:07-10-2022 al NANO THERAPEUTICS PVT.LTD. | System Configuration | | instrument Name QC-HPLC-002 Sorption Acquired by ‘Mittal Patel Prajet Note AAC EP Sats | Sample Name 8522003723, ‘Sample ID iratirnas Orug- Data File Sirolimus Grug Impurity Te ted Batch File Everotimus Drug (8S22002284}.leb Taye val er ala 2 siroliru impurity fathod Fle F309 impunty dm Bote Acad trdoani 387 a. Sram tl Ta | #4 lk 2 a 1 yb | = g_jt 3 = oo assesses ake sees ow Cerise a 7 Teese AD Tan | Date-07-10-2022 Date07-10-2022 NANO THERAPEUTICS PVT.LTD. ‘Sirolimus Std. 100 ppen-07-10-2022-04.led verolimus Drug (BS22002224).Icb ia #Nano-3(Sirolimus impurity). lem 10710-2022 16:26:41 7% MOOS OTS wes Bo ats ano vin “ 4 4 whe TieiesorA Ban Analysis By: Mittal Patel =O Date:07-10-2022 Reviewed By:Oeepak Patel con poppe ate-07-10-2022 NANO THERAPEUTICS PVT.LTD. System Configuration -<> | Testrumnent Maree SQc-HPUC-002 Sample information ‘Acquired by : Mittal Patel Project Name IM GFP Analysis Sample Name alms St, 100 ppm Sample 1D # Srolimus Oruge Gata File £ Sirolimus $14. 100 pprn-07-10-2022-06 ed ‘atch Fle verolimus Drug (8522002264) 1c ian | Mal Injection Volurne 0 Method File ‘ano-3(siolimus impurity em Date Acauired 07-10-2022 16:55:04 my = Tarkan | @ re rn ae a | a i Chromavegram TS eT — - ay | | so] i & i i || | = 1 | \ j j fot \y e At ———— Se OR a ae a Date-07-10-2022 R KONARK RESEARCH FOUNDATION (m4). piper) waa e Plo Ne 398/1. Behind Patel Cc Ground Kachigam, Daman & Di, 286210, Roga Ofice 338, aaryars india Etat, Sune Compe, Lower Pate —_ ‘mara a) ec000% "*rearcn€® aie om ert carat Latarey —— CERTIFICATE OF ANALYSE CERTIGATE WO. knervt2963/2228 [Conca tesuea To NANO THERAPEUTICS PvTLTD D4 Hojwaisnfucte Etat, Sac SURAT Gus64230 1. Marne OF Samal 1 Sins Org 2 Batch No 522009723 3. Date 0 Manufacture Senco 4. Date OF Expy sauazoes Sample Quantity 1023 me 6. Batch Size 2M 2, Reteronce No.Party iNM Sample Recaheed@n 41RD [feaipais Resume 7 i ee i END OF REPORT" [Hote : 1 Samp not crane by 2. Somrpin wil be destroyed wr inating 3. THe robo caarct be uted a an evidence nthe cael ctew or any media witout ice parmisaion Paget OF teietly? anu 2208/01/90 ver ErLeOOTESETON HOLYE'OL] Ad SOLLNSVUSHL ONVATOMUG SreTIOMS SYOnua SNTOMS in wouwie Sa” ONuYO SNWNOUS: a Ani a A x x Nn Oaez Owe OSE nse OEE OOF | (== Se SAuS SNM OBIS | | [ —_ Eye?) SAYG SNWOMS: fe Ehecl AAO PONIEE 82P/SNUNOF “Ol LNSWNELSNI NOLLVGNNOS HOWWaSSY WYYNOM e e ; CONTROLLED COPY Document No. QFfacoa Title: Quality Farmat for Certificate of Analysis of ‘Sivatimus Drug, Ererolimus Drug & Paclitaxel Drug MASTER COPY Department: Quality Controt | Received Bate | AnaiaisRepor tax Received Qty.: ‘Sampling Gty-> arr ag tara ety naa ae ARNE 3, oad fe a2 eRe Ol oh. Jem oy ach. fami Dats = ‘- ; SNo. | Test/Parameter Specification Result | The Retention time of - | Sitolimus/ Everolimus / Paclitaxel peak is the assay eheomatogram of sample should match with Complies e that of laboratories standards. 1, |Srastseetesty | Sotimar oe wae ‘HPLE Limit: - 98.0% w/w ~ 102.05 w/w - | Everolimus Drug Limit: 9.0 55 w/w = 102.0% w/w wa Paclitaxel Drag Limit: «42.0% ~ 107.0% wher WA (Drug impurity Text by HPLC Sirolimus Drug ‘Total lmputities tot Mare Than: - 1.0% | Ererolieas Bra Total impurities Not More Than’: 2.0% 024 WA Dewg FTIA Test a Infrared absorphion spectrum of the drug sample | shouldbe concardant with that of latory standard, Complies Inaecion Rena pA /does no pas 2 pe Speciation. Reference: 5/80, c/ntoe w asain analysis By i Reged Reviewed Sign: Sian. Raproved By ° = cat Soangnt [a] on Zap Date @/-0Y-38a2- Bate O!-O4 2953 Weviion NesOF Effective Date: 01-10-7020 Page: toi CONCORD BIOTECH LIMITED Unit 4, 1482-1406, Tragod Rood, Phot, Dist, Ahmedabad-102225. (india) 2714-222008, COOGGG Fax : +1-2714-222509 Phorice:: 4 CERTIFICATE OF ANALYSIS Prdudt | SiROLIMUS ABNe Ca aa Batch Na, | 1608522008 Mig, Date Mir 3023 Tach sine | RO gw Hetest Date Feb 2035 SN. | Tests ‘Specifications | ‘Observations 7 | Beasipion OAT ke open apelin pom, | OFF wie ena power oar lds 7 | Say ‘Solute ta watiasol wad” Boey sole bn | Sollee ella wad ely soibie : seston, inseetntre 7 | eons (ay By Infrared absoxplion Tiled’ ipecivun of the sample exhibit sabia a the sme wavelengths a8 that of similar preparnon af sivlimus veference unterial working andar. Tatiared spscium of the sample exhib maxine ot the Bie wavelengs 95 dt of sinilar prepantion of sirolimas working salsa pre (oases ae bee phat ich lf ar Sone 6 Fur wiee cel e|"e HmS ree eo i Lome = ti esi ee wai ‘S| Specific optical rotation ‘Between -140° and -E50" 14" Les eee “Se zane ee saa. mes ish foaoen hd cael | Caste of aomers Teomer A oi ere an 030% Tie Former C ot rorethan $1 % 37% | Assay (By HPLC), On dred baaie DOH RO 05% Suao of Tracy Bd Earner) TA [Resa oleate (By GC Hexdsaceh ‘Katia RMT 4000 w ‘tei Nu 10 ppe 1 pee Dist her MT 4000 pe 33 po Bgl aceale SM 4000 pe 15579 Metianat NUT 100 pe Below deteton Lit Petri ether RACE £00. pp Belnw detection Limit Tolanas NMT 1 pe 3 ye Met frmaie HMTI5_jpe Belo dtztion lini [Crt se Foe sfembten Di@9} SI irons TE | ileal enomaraoa a “Tea vise aerobic eo Waar Toor Tas an eT ‘out mld at jest couse MAT 100 oid ss than fi “Tet fc wpeciied coogi cal ‘Shale Abana Aiea Saloeta trp ‘Should be Abst Absent dg S.mureus ‘Shri be Abst Absent Picton acrypoons Showld be Abe forage: Preserve in closed coriaiaers protecied om high sa cold place Q- FC) ‘Remarks: The riers! conipica ut per inhouse wpeeitcat.on no: STMQOIFPVOD-0 Date of Report: Mar, 2002 ‘Compiled By (QC) (KK, VakiF- Manager) a Date: a ‘Checked By (QC) (S. K. Ma M) Date: seb Rogloterad Oitiow : 1ur-1a40, Comporate Orties : 81601-1602, irasad Road, Dhol, 1 ‘Alunedabni!102225, (Irdll9) Citi flo U24220GI1994PL.C007840 Wing, bfondeal Heights, Iskcon Croax Road, 5. 6. Highway, Aimedabad-380 015, Gular -19-88034725 Wohaits : werw.concardblotach.com CONTROL ‘Document Na ‘oFfoctas Toleatiie god MaaheRARe o>. Apia. Ben Mme . eo 7, i Meni Aon tead Biatech Limited NTPL Lot No. ] In-House Lot Na.: ‘Sample Gry: 42 mg I Rea RB 3. Alaa PEPE Mauch. 2ate [OO hauay, 2028 Cseraion Table: Sample Type HPLC Area (vor) Cone. (ppm) e ——e 1212.4311.¥0 remcd ae 12u755)4 2u5 36 lca: Mean Std, Area > Std Nev Sid Node Sid No 3+ Std No 8 Std Nos 3 | poem ert Ase Le2NITE2 F (2213107 + TIT Eee 4 eS AB } ——— esesSsSsssssSsSeSSSSSS— z [Puan etd Mer 2Zd3HI. ¥¢ Mean Std. PPM = Std iio 3+ Std Node Sid hea Je Stang da Std.NOS L al 2 Meen se Pi V4 20). 084 AF. FTF AF SOF A pe A OE RED it ee TRIE = e. Mara ett PPM > 9 6¢ _Man Standard Area . 1H 1SI14 be Ag ft [Drug it ppm in 2530 ‘Assayin® = Assay Sample Area X Std Cone Iopml_ ‘Mean Std. krea__-Mean Sample Conc. ppm) Ipesuy in x. PUTS 4 9-6L vag 90 Lizz Fe 5B: Posey Jat. ). O2K5H Ko, g12IH x94 40 > 49,407. X Drug Label Claim (Standard) Revision Na 02 Effective Date: 01-10-2020 Page: Tat? Some a8 ay | 45.94 336 2. Tt NMI OS ¥ NiT350% tats O% wnat 18% Everolimus isomer | Everolimus isamer | Sirolimus bomer Drug Bie © Bc saad t pee oo i ve Teeroienua Ore a = 2 = Tint NETS maTsax | wMTOSR NuTIO® — Conclusion: «The sample complies / does not comply as per specification. Reference: O5/RM008, O5/RMOO9. ‘Analysis By Sign: [__ [Reewed rs DEEAOL PTE San PH pCrel Sig: Date Fh a3 pate Date F-09005 2 Date: Effective Date: 01-10-2020 Page 2 of? NANO THERAPEUTICS PVT. LTD. Data Filename Blank Moot -3-05.202240 kd Methox! Filename = NAND-Sirolimms) Sem Date Aegoined | + eg0/0022 2:38:24 PM Instrument 1D QCHPLC-001 Chroma Blak Meal. @)F:\QC-HPLE-O0 Dutt 2.March- 202208 tank Meat 209-2022. es av Ss Pe ei ea 1300. 1000 | 500: | Detecine A CHL 2760, 1S Peake FAQQC-TIPLC: 00 Duma 202 29March- 2020 Moot §03-202.0 ted RaportiRepore Ester) NANO THERAPEUTICS PVT. LTD. Spe fafomationn @FSQC-HPLC-O0NDaa2022 Marc 20228lank Mell 3C8-N22-Ot ed Acquired by Sample Name Blank Met Sample 1D Bask Injection Volume = 20. Dias Filename 1 lake Meal-30-03-3002-8 ed ‘Method Fuleume = NANO-(Sirolimus)lem Dive Acquited ‘yao 33:88 PM Taster 1D © OCHPLC-OOL — " ‘ak Maal: @FAQC-HPLC oniustovan fe 2ank Mac 30-83-2007 0d 100: 1000. e su soe) a9 a 1 Det ACht / 23am, Peak Table @FAQC-HPLC-O01WData3I22.March-2022Btane MoH 30-08-2022 Sod Deiter ACE 276m ReponiFsport Edtor) NANO THERAPEUTICS PVT. LTD. ‘Sample lftrmatonn @\QC-HPLC-001\DenatS27\March:2022 Sins Sl 200 pps WO08-2022-08 ed sta Sarmple Name Siri $d 200 ppe Saunt ID + Srimas Drop Injection Volume 20 ul Data Filenare Sirois Sw 200 ppn-30.3-200-01 ed Mashoa Flame AN Sion Date Acquired 3/90/2022 321228 PM Instn 1D ‘QCsHPLE-01 (1 Ben 240m Peake @ AGC HPLC-U0 NDuistQn22\Wlarcb-20221intinae Si 20 pen bHR-PB22-0 bed Detceaoe ACh! 276m a [Wii ing Factor “Theor Pines” Cees ‘NANO THERAPEUTICS PVT. LTD. ‘Sample informations @FVQC-HPLC-001 Wu 2002Marely 2Sirotimes Std 200 pp-MO4I3-2022N2 ted Acme by Serpe Name Stl Sl 200 pp Single Ib Stn Dap Bueno” | Stn S20 pp 30.53.2033 Netedfiletame —: NANOSaclinah ico Deseret Sanat en PM tte | QPL Chromatogran . ‘Sroimes Sit 200 pp GFAQC:HPLC-00 Daiai2022\M ch 2002S Sul 200 pp 30-03-2020 ed 100000, j o> fr oo a so 7s 1 DeACH! 276m Paki @P9CHPLC-D Dan? Mach 222 Sl 300 py Dest AC DA - a ‘race aT (ois hai es 3 ag — “eso as ‘tat? ton = = 1 rea io? 96.877 ReeportiResort Ector) NANO THERAPEUTICS PVT. LTD. orator f° AGC:ANPL.C-00 IDaatoO72March- 2027S lens Std 2 pp HOAE-2022-073 Jed ees Srv ‘Sirolimus St 200 ae Pm 1D roms Prog Injevtion Volume aL, ‘Data Filename + Simms Std 200 ppm-30-05-2022-03e ‘Metbod Filename; NANO-(Siraliams em. Date Acgsird | 2 HOWE 350636 PM Tsomest FD F QC-HPLC-001 - a Sirlims Si 2 ppm @F:MXC-HPLC-O01 Dau 21March- 202 Sirois Sl 200 pn M-2022-0' ek PeakToble @ QC: FFPL.C-00NDatst2027\Mareh- 2022 Silas Si 208 pp HOA 2022-03 fd Deter AChl 276m Peake] Reapert(Renort Editor) NANO THERAPEUTICS PVT. LTD. Sample Iforratiamn @#F-QC-HPLC.001\DaraS007March-2022 Sirolimus Asay Sample: 300 py led Accuired by Mina ‘Sample ame eoasz2003- ‘Sample ID + Sirois Dwg- Injeion Volume 20. uL. Daa Filename Sicolimus Asay Ssmple-700 ppm ie ‘Method Filename; NANO. |(Siolaas im ‘Date Acquired 802002 4-00-10 Pa ‘nsrameat ED ‘OC HPLC-OD1 {eans22003- @FQC-HPLC-ONNDaistQO27 Marc 2022S Assay Sarple 200 pen Bel 00 25 | Det ACA / 27am Peak ble @F1QC-HPLC-O01\DuntU22March-2022Sitions Assay Sample: 200 panied |, Beara 26am fl ‘Name [abil ol [ses 3076] O.00|ppe TET Ret f NANO THERAPEUTICS PVT. LTD. Acguied by st ‘Sample Name Siculiem Sad 200 ppm ‘Sample 1D + Sioimes Drog- Injection Volume: 20. ‘Dota Flenare Sirolinmn Sid 200 ppm 300%-2002.04 ‘Mesho Filesae —: NANO (Sirolimus em Dae Acquleed 102002 4:77:41 PM Iearumen ID = QC-HPLC-O01 J ie cot E = bo as 1 Det ACH #27%00 Peak Tbe 6 F4QC: HPLC-DoN\Datai2022Mares- 2022s Stl 200 ppm-M5-20022-08 Jet Deecioe ACH! 274m ‘Reportifeport Editor) NANO THERAPEUTICS PVT. LTD. Sample infornaticen @P\QCHPLC-00 NDusk2O2 March 21278 woes S200 ppm: 3009- 2022-05 hod ‘Mita Acguited by F Sample Name + Sima St 200 pp Sample FD Sirolimus Drup- Injection Vaume =: 201. Data Filename + Sirlinss Sid 200 ppm-30-03-2022-05 ‘Method Filename: NANO-1(Siraiimas ee, Dats Acid | + Navona 4:46:15 PM osama ID 2 QC-HPLC-cor Srl Si 20% pen- @F:NQC-HPLC-O0 Wau 2 March» 202Sirolimas Sal 200 ppm MA5-2022-05 tat ; I} 3 | | et a ae | an as so ts ae" 1 DotA Ct / 260m a 1s ones Dec AChi PaporttReport Ester) NANO THERAPEUTICS PVT. LTD. Sas nfo Acseiedby Mit Sarple Name Blank ACN: Sarpe ID Blak ington lume 30 Dai Femme Blok ACNA1G5-30201 264 Mato Femams ——: NANO-1Sirohms parton Date Aces Saunas 100827 AM Crretogren n Blank ACN: FAQC.HPLC-O0 Denes 200DBlnk ACN. 08-309-01 ed " 2300" ol IDAtAGa Detetor ACAI 27am ‘Blank ACK: @FAQC HPLC-0 Daler 202k ACSI 08-3020 bd Peake @FAQC-HPLC-00 Data? 2AM M}2NBlank ACN315-3002-01 tod PagscrtiFeport sitar? NANO THERAPEUTICS PVT. LTD. Sample Information | ewe ed SanpletD = Blank | Injesion Volame au Fienane Blank ACN-1-03-2022-0 ed Method Filename NANO-1Sialims npr em Date Acq FMBV022 1033 AM —— —_—_——_ = 1 Blank ACN: QC-HFLC-01 Dasara 2022ink ACN-ABA-202240 ed “ |; 7 \ 2500 l\ tS ode . . | aac @ ° 3 is 2 3s nn 1 Daan F277 < ‘Blank ACN. FAQC-HPLC-G0NNDeai227)March-2022\Biank ACN-31-03-2022-02 bea ig ee ee — | | | I\ | oak Table FAC: HPLC WDeea0020Mare-2022%Blank ACN-31-03-2002-00 ed 1 DeLACHL/ 27am etetoe ACSI 277m NANO THERAPEUTICS PVT. LTD. Samp inormaton Assi by _ Mina Some Nae Sirol Suit 10 pp Sample ID :Siaims Drag Injctioe Volume: aa Dau Flenare Sica Si 100 pp 31-08-2022.08 Methad Blenane | NANOS Ipurity erm ate Acguires MaLi3022 150839 AM 7 Sims Si 400 ppn- @FAQC:HPLC-OoNDuaOEDMerh 2022Stoet 10 ppn31-03-2002-01 e 20000} : ] Hd ‘Chrceumgrans Sirolimus Su 100 ppm @F:\QC-MFLC-O01 Waun2U22 March: 2022Siralions Sl LOD ppen31-03-2022-01. fe [Raport(Report Editor) NANO THERAPEUTICS PVT. LTD | ‘Spl laf Aes iy 2 Mita Sample Name = Sialimas Sad 100 ppen= | Sample 1D Sirolimus Hrug- Injection Volume: 20 ol Dota Plcaame Siraraa Sa E00 ppe31-03-3022.400 et Mets! Flenwme — NANO-3Sirlinss lng lem Date Acquired BUR? 1a042 AN Seti St 10 port 6 FQC-HPLC-01 Dutst022 arc 2027S linus Si 10 pen 4.20022 ed 1 DetAOHL 277m 1DeeAChI Stim Se 60 pp @FQC-.C20 tO Oe 2027S 09 ppn 31-0202 2d - 1 De ACh / 277m Peak Tible @FAQC: HPLC. \esib027March-200Sindimns Std 100 ppm 03-2002. fed 105] eeACM Iam = Nae Tale | ae [alia ry tags 417 sia NANO THERAPEUTICS PVT. LTD. Pe Sample formate Acie by Mead Sectice : Seti Sd 1009p + Sirois Drag Injection Volume: 201ul. sa Filename ‘Sizlinus Sud 100 pnw’ 405-2002-08 ed Method Fiename IANO Sirol Input em Date Acid MAMBO 1231-06 FM Chromatogr ' Siclimnss Sud (06 ppar @AQC-HPLC-001 aus 7March-2007Sirlimas Se 100 ppm 31-03-2022-03 et H la no | | i @ = —— = J, ts ap oF Sots Bea ie ; 12500-] i ied a ite! i | i e|* j H) j BL ve oan poy ae ma, 1 DetAChI (277m ‘Peak Table @FAQC-HPLC-OON\Dyea 2022S 2022Sirlinds Sid 100 pp SE-03-2022.1 ed ACAI 2TI0m : Ta 1 tine == — ea ‘anton jug tad! — ast oa Takioew ThE 1 Uninos 1057 aaa Studies ALoomar i Cian] 000] ‘0 19.84 Aaportteport Estar) NANO THERAPEUTICS PVT. LTD. ‘Sarple Information Acute by Mina Sample Name 1eORS2200%- Same 1D Sirolimus Deug- Injection Volume: 20.uL- Dau Filename Sirolimus Deg Testing Jad Date Acie ‘SAL2022 1241-39 PM ‘608822003. FRAQC-HPLC-A0i \DataSOrF Mah 2022Giralinas Dr Lnpariey Testing 1 De ACChn /27 Tam ss {eans2203- FAQ HPLC OOS 222i Dr lnpry Teg = | 64) ba t {esti yoo) RapertiRepert Exiter) NANO THERAPEUTICS PVT. LTD. Sample Information Acie by Mina Sample Ne Situs Sd 100 pps Samp Sesima Des Injection Volume: 30 DenFicaame "Sars Sl 0 py31-09:222.04d ~ Media Flctame —; NANO-XSirands npn Dae Acquired ‘Ma o022 1242 PM Ww 00000 o90-| ——— L e o 5 10 6 20 EL 1 e.Acha (277m “Chromatogr Srolinaes Sed 100 pp: @FAQC-HPLC 0D 27 March 2002 Sinsimas Sud 100 pM -05-2022408 Jd eee 1 | ‘ 1 Daca 27 akfibe @PAQCAHPLC-Oat2027\Mach AIS Sl 10 pn] O22. a hee Secrest lg ee | eee Usk asa] — “ass atola cA {gt — ase eet — at —t Wikre 1ao| — seal — 8d — hg i ida] |-—3at|\— 36) } SO pe a 4 12H Ae) i 18 the Bet at eae 13 ai] Hass] 3100] 007) 00) sa 081 Se1 1000 \RaparttReport Editor! me NANO THERAPEUTICS PVT. LTD. Sample aration | Aci by Mina | Sept Nene Sram Sl 100 pp Sap ID : Sirona: Orage Injection Volare 20uL. Data Filename irl 10 pe 31-03-2022. ed Mebod Fienare NANO. Soli tnpuriyem Date Acquired ¥81/2002213:26 Pat Wy. “oxo = ADsLAChI ‘Sems Stl 100 ppm SEF QC-HPLC-0O1NDuta027 Mare 2022Strolirmus Si 1 ppm-8 | -03-2002.05 Je 5000 —— - isa oom 1 Det Chl 1277 am Pea Table @F\QC-HPLC-001\Data\2022%March-202'Sirlions Sia 100 pr-31-03-2002-05 ed Tins | Ae La Taio igre | Tole ae TOs, sone 1 othe ior bal alae | Sas That 1983 KONARK RESEARCH FOUNDATION i - id TESTING A CALIBRATION LABORATORY 5 Plat No 398/1, Behind Pate! Cricket Ground Kacnigam, Oaman 4 Ou, 396210. ees ie ‘Regt Often 33, Adyar uninal Enotes, Syren Compound, Lowes Para, ‘turbot MH} 800083, Penean seen ian mene SERIWIERTE GF UAL cennncaTe no

    You might also like