CED
a
CERTIFICATE OF ANALYSIS
Rie HR AG
No.:COA-S170305002-01
[Product Name
Solesbu Code ae
PahBEs | ema fe =
ts. he. YAKBu-EM201703201 ee xing 2017.03.04
Test No. Tesi Metnod TWEYAKE 00
bee Prone iii, ‘SPC-YAKB 00
Bee Date | naizo19.02.28 a 119.80kg
Packing Size 7TE.G0kg/package rodueed by ‘Synthesis Plant IT
| eae. fe PsbeMs eri = I)
‘Test lems ‘Acceplanca Criteria Resulis Conglusion
Pr RS ‘ae eae
‘Appearance White or off.white powder. Wile paver Conforms
teak EL. OR3 FT Bik Bx owe
“The TR spectrum of the sample | The IR spectrum of the sample le
ix | Should be concordant with hat of | concordant with that of the | Conforms
the Reference Standard. ‘Standard, SE
254 Be sXe ALi He
|| Thetetenton time of the major [Te retenion tne of the major
Identification peak in the Test Solution should | peak in the Test Solution is
Hi be concordant with that in the | concordant with that in the
Hetc | Standard Solution as obtained in | Standard Solution as obtained in | Conforms
Assay. Assay. eRe
ARNT, GMI | em, GR Hy
SR ATG LICE AGRA | RAT. a A EA
dB siete.
Claiity of Solution Solution should be clear Clear Conforms
eG Aaa Bt bg erie
Water 0.5% 0.05% Conforms.
ASP : : awe
Tpurity A ane Not detected Conforms
A Ft th Heme
Img 8 Conforms:
on 50.10% <0.05% coum
Tmpuriy & Not detected Conforms
"HG ont et Feu
ee 30.10% Not detected Conforms:
Related substances meg we ees
AROK Tine 50.10% I a athe
impurity jat detected forms
Ene Ss et Hawe
Unspectied
: Not detected Conforms
Impurities 50.10% ae eae
Total impurities Conforms
iy ss S1.0% 0.05% HOME
98. 0%-102.0%
fom {on the ani basis) 100.2% oo
iba! oan tao (Heat bai mw
‘Optical Rotation conforms
eee +37,0°441,0° +387" aawe
‘Ada. Xiaba Development Zone, RuyuanGounty, Shaoguan City, Guangdong
hk: RAMAN AMAR LARA RAAMM PSIERE, Me, 542721
(+86)0751 5286508, Faxc(+86)0751-5296521
Dec.No./SCFFS : AN-SPC-YAKBA Ver. NaH : 00
Page 1 of
vinee,$12721, ChinaResidual
Solvents
aR
ee
$1000ppm
Elemental
impurities.
THRABA
Crystal form*
ate
+
‘There should be characteristic peaks |
BH CAS): $1.5ppm
(Cd): = 0.5ppm
3% (Hg): $ 3.0ppm
[___® ePby S0.8ppm
#8 (Co): $5,0ppm
L
4 (ND: <20ppm
8 CV): 10pm
#8 (Sn); <600ppm
#8 (Mg). $1000ppm
at6.0420.2", 8.1320.2°, 10.3320.2°,
12.6520.2", 20.09%0.2", 20.7720.2°,
and The XRD spectrum of the sample
correspand to that of crystal form VI.
HORA HE 6.0420.2°, 8.1320.2°,
10.3340.2", 12.6810.2", 20.0940.2",
20.7740.2°sb ERE, 15 VIE
XRD fit —
Thare are characteristic peaks at
6.11", 8.22%, 10.40", 12.73", 20.16°,
20.83", and The XRD spectrum of the
‘sample correspond to that of crystal
form VI.
‘PRREMTE 6.11", 8.22", 10.40°, 12.73",
20.16", 20.837 SHEN, 5a,
XRD Hg
‘Conforms
Ae ie
‘Add.: Xiaba Development Zono,R
luyuanCounty, Shaeguan City, Guangdong Provines,512721, China
SAR A AL HAAR AA FS
Tol.(+86)0751-8208508; Fax-(*86)0751-52868:
sis 812724
24
Doc.No/t hit: AN-SPC-YAKBA Ver, Nouba : 00
Page 2 of 3ED
No.:COA-S170305002-01
Batch No,
Bess YAK
Test ema Conclusion
Le] Sms it
Dio: 1.84um
Pso Intormatively =
ne Oe a
Buk density Informatively =
er sien —
Tapped density Informat
Ai A ae cat
TAMG Orch me —
Microbiological Sanam =
Examination, $10?cfulg = -
SE ME Be
EMA Ae Escherichia coli (ig) -
ASAE MA 19 KE Agta =
Note: lanes thatthe testitem may not be conducied on every batch, bu oniy onthe Tat ree batches in
every year. “signify outsourced test
Ste: PAWEL, teh he Tate. fir ossFete OH
Conclusion: The results of the above items meet the in-house specification
Reported by/Date
IE AVA: fhiret
Reviewed by/Date
ERNE ME: Hat
Soy
‘Approved by/Date
‘mE AVE: aee"L
‘Add: Xiaba Development Zone,RuyuanCounty, Shaoguan City, Guangdong Province,512721, China
AARNE
Saks RA ERT Re HA
FRA, Wel, $12724
Tel.:(+86)0751-5286508, Fax:(+86)0751-5286521
Doc.No./ 4H: AN-SPC-YAKBA Ver. NoJICE : 00
Page 3 0f3