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CERTIFICATE OF ANALYSIS:
Product name | Tiletamin hydrochloride | |||
CAS No. | 14176-50-2 | Outer Packing | 1kg/bag | |
Production date | 20210402 | Shelf life | 20210421 | |
Standard adopted | EP7.0 | |||
Items of analysis | Specification | Results | ||
Character | Off-white to White Crystalline powder | Off-White Crystalline powder | ||
Solubility | soluble in Ethanol (96%), Almost insoluble in | Complies | ||
Identification | Specific Rotation -67-69.5° (on anhydrate basis) | -67.4 | ||
Identification | (2)IR:Meets the requirement. | Complies | ||
Identification | (3)Optical purity Test | Complies | ||
Identification | (4) Chloride Reaction | Complies | ||
Clarity | Clear,not deeper than Y6. | Complies | ||
PH | 2.8-3.4 | 2.9 | ||
Related Substances | Impurity A≤0.15% | 0.03% | ||
Related Substances | Impurity B≤0.15% | Not detected | ||
Related Substances | Impurity C ≤0.15% | 0.04% | ||
Related Substances | Unknown single impurity ≤0.15% | 0.07% | ||
Related Substances | 0.1% Total Impurity≤0.5% | 0.18% | ||
Impurity D | Impurity D≤0. 5% | 0.05% | ||
Water | 4.5%-6.5% | 5.7% | ||
Heavy metals | ≤10ppm | complies | ||
Sulfate Ash | ≤0.1% | 0.04% | ||
Assay | 99.0%~101.0% | 99.4% | ||
Conclusion | Qualified |