| Function: | Vitamins and Minerals Deficiency Drug |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
| Type: | Analysis reagent |
| State: | Solid |
| Volatile: | Not Volatile |
| Customization: |
|---|
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Audited Supplier | 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 115ºC and 119ºC | 115.4ºC |
| 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 2ºC-8ºC |
|
| Conclusion | The sample is in accordance with USP40 | |
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