杭州东瑞医药科技有限公司

HANGZHOU DAWN RAY PHARMACEUTICAL CO.,LTD.

CERTIFICATE OF ANALYSIS

Cyanocobalamin (vitamin B12)

Batch No.: DR20131013 Piece: 27kg
Manufacture Date: 2013.10.13 Expiry Date: 2018.10.12
TESTS:

Items Specification Results

Characteristics Dark-red crystalline powder or crystals Conforms
Solubility Sparingly soluble in water and Conforms
ethanol(96%),practically insoluble in acetone.
Identification Ratio of optical density
A361/A550nm: 3.15~3.40 3.26
A361/A278nm: 1.7~1.88 1.86
TLC: Conforms Conforms
Chemical:Positive Positive
HPLC：the retention time of major peak of the Conforms
sample solution corresponds to that of the correspond
standard solution
Pseudo cyanocobalamin USP(separator) Conforms
Related substances
Total impurities ≤3.0% 2.0%
Single impurity 7β，8β-lactocyanocobalamin≤1.0% 0.3%
50-carboxycyanocobalamin≤0.5% ND
34-methylcyanocobalamin≤2.0% 0.7%
32-carboxycyanocobalamin≤1.0% ND
8-epi-cyanocobalamin≤1.0% ND
Any other unidentified impurity≤0.5% 0.4%
Loss on drying ≤12.0% 1.8%
Assay on dried basis 96.0%~102.0% 98.6%
Residual solvents Acetone: ≤ 1000ppm 24ppm
Ethanol: ≤ 1000ppm 73ppm
Total plate count(CFU/g) ≤ 100 50
Yeast and Mould(CFU/g) ≤10 < 10
Enterobacteriae Negative ND
Staphylococcus aureus Negative ND
Pseudomonas aeruginosa Negative ND
Endotoxin ＜0.35EU/µg Conforms

Add:1018 Guangyin Building No.42 E. Fengqi Road,Hangzhou,310012 China

Tel:+86-571- 85335020 Fax: +86-571- 86948329
E-mail: agnes@dawnraypharma.com Website: http://www.dawnraypharma.com/
 杭州东瑞医药科技有限公司
HANGZHOU DAWN RAY PHARMACEUTICAL CO.,LTD.
Storage: Store in airtight container and at 15-30℃，protected from light.

Conclusion: The results conform with USP 36/ EP7.0.

Analyst: Joe Yu Checker: Agnes Zhong QA.Manager: Sun Wenhu

Add:1018 Guangyin Building No.42 E. Fengqi Road,Hangzhou,310012 China

Tel:+86-571- 85335020 Fax: +86-571- 86948329
E-mail: agnes@dawnraypharma.com Website: http://www.dawnraypharma.com/