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CERTIFICATE OF ANALYSIS
| PRODUCT: Daptomycin (Cubicin or LY146032) |
PRODUCT No.: D168 |
| CAS: 103060-53-3 | LOT No.: D-A101225 |
| MW: 1620.67 | STORE: -20º C |
| FORMULA: C72H101N17O26 | Country of Origin: China |
| Analysis | Specification | Results |
|---|---|---|
| Appearance | Pale Yellow – Yellow Crystalline Powder | Conforms |
| Identification A (IR – USP<197K>) | Conforms to Reference Standard | Conforms |
| Identification B (In-house HPLC) | Retention time on peak corresponds | Conforms |
| Identification C (UV) | Conforms to Reference Standard | Conforms |
| Assay (HPLC calculated on anhydrous & Solv. free) | ≥95.0% | 100.1% |
| Assay (Potency Anhydrous Basis) | ≥900 µg/mg | 970 µg/mg |
| Specific Rotation (EP 2.2.7) | +17⁰ to +25⁰ (calculated on anhydrous & Solv. free) | +21⁰ |
| Water content (USP<921>) | ≤4.0% | 1.1% |
| pH (In-house) | 3.0 to 5.0 | 4.4 |
| Residue on Ignition (USP<281>) | ≤0.5% | 0.1% |
| Total Impurities (3 + 6 + 1 unspecified) | ≤5.0% | 1.4% |
| Solubility | Water, Ethanol, Methanol, | Conforms |
| Stability: | Stable at -20º C for at least 2 years. Store dry and protect from light. |
| QUALITY ASSURANCE: | Verified upon data received from manufacturer: |
FOR RESEARCH or FURTHER PROCESSING – NOT FOR HUMAN or DRUG USE