| Items | Standard | Analyzed Results |
| Description |
Should be a white needle-shape crystal or white
crystal powder ; give out no smell , no taste ;
be easy to lose activity in air or light . |
White crystal 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 ºC and 119 ºC | 115.4 ºC |
| Specific Rotation | Between + 103 and + 106 | + 103.58 |
|
Solubility |
Freely soluble in alcohol |
Complies |
|
Reducing Substances |
<20ppm |
Complies |
| OrganicVolatilityImpurities | Corresponding using method IV(467) | Conforms |
| Assay | Between 97 % and 103 % | 98.78% |
| Store Condition |
Store in airtight container ,under nitrogen,protected from light,At a temperature
between 2 ºC -8 ºC |
|
| Conclusion | The sample is in accordance with USP40 | |