Vitamin D2

Product Name

Vitamin D2

Batch Number

120601

Potency

40,000,000IU/ g

Analysis Date

20,06,2012

Report Date

25,06, 2012

Analysis Based on

USP 29/BP2000

Product Manufactured by

Sichuan Yuxin Pharmaceutical Co., Ltd .

Product Provided by

Sichuan Yuxin Pharmaceutical Co., Ltd .

Product Quantity

500kg

Manufactured Date

18,06, 2012

Expiry

17, 06,2014

Standard

Analyzed Results

Properties

Should be a white needle-shape crystal or white crystallized powder ; give out no smell , no taste ; be easy to lose activity in air or light .

White crystallized powder without any smell or taste .

Identification

1. Dissolve about 0.5mg of vitamin D2 into 5ml chloroform, add 0.3ml acetic anhydride and 0.1ml sulfuric acid, shake and mix vigorously. The mixture is initially produced bright red color , and then rapidly changes violet and finally blue to green .

Positive reaction

2. The infrared absorption spectroscopy should be in according with spectrum of comparison

The infrared absorption spectrum of the sample is in according with the standard

Examination

Dissolve 10mg of vitamin D2 into 2ml of 90% ethanol, add 2ml solution of digitalis saponin and incubate for 18 hours. No precipitation or cloud should be observed.

Passed

Melting Range

Between 115°C and 119°C

115.1°C

Specific Rotation

Between +103 and +106

+104.6

Reducing Substances

Light absorption of sample<Light absorption of standard sample

Complies

Ergosterol

None

None

Solubility

Freely soluble in alcohol

Complies

Organic Volatile Impurities

Benzenenot more than2 p p m

None

Content

Between 97 % and 103 %

100.05%

Total Microbacterial Count

Not more than 1000CFU/g

20CFU/g

Total Yeast & Mould

Not more than 100CFU/g

5CFU/g

Escherichia Coli Presence

Absent

Absent

Store Condition

below 10°C

Conclusion

The sample is in accordance with USP29/BP2000