㊨DSM

VC Ascorbic Acid regu看ar, 25KG BAL

CER7THCA TE OF ANALySIS

P「oductcode     : 501 5838368 Batch Size     : 15,000KG

Lot No.       : HPB2012163 Manufacturing Date : 22.12.2020
Analysis No.   : 75708764 Best use before  : 22.12.2023
Report Date       29.1 2.2020

Test Result Limits/Specification Dimension/Units

*Appeara nce Correspond White or aImost white, CryStai or
CryStaI冊e powder
SoIubitity Co「respond F「eeIy solubie in water, S=ghtiy
SOIuble in ethano口nsoluble in
ether o「 chloroform

ldentification A Positive Positive

ヂミIdentification B Cor「espond lR
*MeIting Point 191 190- 192
*Specific Opticai 20.9 20.5-21.5
タダ

Rotatio n
’CIarity and CoIor of
Correspond CIear, nOt mOre intensely than BY7
Solution
*pH(2%, WN〉 2.5               2,4 - 2.8
*pH(5%, WN〉 2.3               2.2-2,5
Loss oれDrying <0.1             <=0.1 %
Residue on Ignition <0.1             <=0.1 %
Arsenic(as As) <1.0              <=1.O ppm
Heavy Metals Co「respond  <=0.OOO3%
Lead < 0.5             <=0.5 PPm
Mercu ry < 0,5              <=0.5 PPm
l「on <2               <=2 PPm
Copper <3               <こ3 ppm
Oxalic Acid Correspond  <=0.2%
ResiduaI SoIvents(as < 250             <こ250 PPm
methanoi〉
★Assay %
99.8 99.0- 100.5
Tota看PIate Counts < 1000 <= 1000 CFU/g
Yeasts & Moulds <100 <= 100 CFUlg
Escherichia.CoIi Correspond Absence in lg
SaImonelIa Correspond Absence in 25g
Staphylococcus Aureus Correspond Absence in 25g
impurity C <0.15 <=0.15 %
看mpurity D <0.15 <=0.15 %
Unspecified Iimpurities <0.10 <こ0.10 %
Tota=mpu「ities other <0.2 <= 0.2 %
thanC&D
Cadmium <0.5 <こ0.5 PPm

Conclusion: The product with this batch number meets a= 「equirements when tested according to the monograph of
USP/FCC/BPIEP/E300 in cu「「ent version,
Test items marked with ★ are based on routine batch anaiysis. Others are tested at 「egular intervals.
This is an eIectronic COA. The data from batch anaiysis are in accord with the actuaI test data, Which are true, COrreCt and
COntrOIled・ The data from periodic anaIysis are contro=ed at reguia「 intervaIs as part of our assu「ance program.

QC Manager Qua=ty Manager

DSivi Jiangshan Pha「maceuticaI (Jiangsu) Co. Ltd.

No 61,Jlan了1Shan Road J間鴨j証l鉦、南冊・こ。 2昭500, PRC