CERTIFICATE OF ANALYSIS
|
Product Name:
|
Colchicine
|
Batch Quantity: |
5Kg |
|
Batch Number:
|
160301 |
Manufacture Date: |
Mar.1,2016
|
| ANALYSIS | SPECIFCATION | RESULTS |
| Appearance | Like-white powder | Complies |
| Odor | Characteristic | Complies |
| Assay(Colchicine) | ≥98% | 99.3% |
| Sieve Analysis | 100% pass 80 mesh 100% | Complies |
| Loss on Drying | ≤2.0% | 1.06% |
| Specific rotation | -240°~-250° | -248° |
| Heavy Metal | <20ppm | Complies |
| Arsenic (As) | <0.5ppm | Complies |
| Lead(Pb) | <0.5ppm | Complies |
| Cadmium (Cd) | <0.05ppm | Complies |
| Mercury (Hg) | Not Detected | Complies |
| Microbiology | ||
| Total Plate Count | <1000cfu/g | Complies |
| Yeast & Mold | <100cfu/g | Complies |
| E.Coli | Negative | Complies |
| Salmonella | Negative | Complies |
| Conclusion | Conform with specification up to standard of USP38 | |
| Storage | Store in cool & dry place,Keep away from strong light and heat | |
| Shelf life | 3 years when properly stored | |