Items | Standard |
Appearance | Yellowish -green,Crystalline powder, hygroscopic |
Identification | A. IR B. Examine the chromatograms obtained in the test of composition. |
Solubility: in water in ethanol (96 per cent) in methylene chloride |
Soluble freely Soluble slightly Practically insoluble |
Principal peak | ≥80.0% |
One peak | ≤10.0% |
Other each peak | ≤5.0% |
Ethylene oxide | ≤1.0ppm |
Heavy metals | ≤20ppm |
Arsenic | ≤1.0ppm |
Mercury | ≤0.1ppm |
Cadmium | ≤1.0ppm |
Lead | ≤3.0ppm |
Sulphated Ash | ≤0.4% |
Loss on drying | ≤5.0% |
Assay(Dried substance) | 95.0% -105.0% |
Microbiological test: | |
Total aerobic microbial count | ≤1000cfu/g |
Total yeasts and moulds count | ≤100cfu/g |
E.Coli | Negative |
Salmonella | Negative |
Coliforms | ≤10cfu/g |
GMO/BSE Status | Not genetically modified organism. Free of BSE. |
Storage | Store in an airtight container,protected from light. |
Sterilization | No Irradiation and ETO. |