Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Customized |
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SPECIFICATION |
Analysis Items Specifications Analysis Method | |||
1. | Characteristics | White or almost white crystalline powder or colorless crystals |
EP |
2. | Identification | IR:Complies CA:Positive | EP USP |
3. | Melting Point | About 190ºC | ChP |
4. | Specific Rotation | +20.5°~+21.5° | EP |
5. | Acidity(pH) | 2.1~2.6(5% aqueous solution) 2.4~2.8(2% aqueous solution) |
EP In-house |
6. | Assay | 99.0%~100.5% | EP |
7. | Loss on Drying | ≤0.40% | In-house |
8. | *Impurity E(Oxalic Acid) |
≤0.2% | EP |
9. | *Related Substances | Impurity C≤0.15% Impurity D≤0.15% Unspecified Impurities≤0.10% Total Impurities other than C,D≤ 0.2% |
EP |
10. | *Heavy Metals | ≤10ppm | In-house |
11. | Arsenic | ≤3ppm | In-house |
12. | Lead | ≤2ppm | In-house |
13. | Mercury | ≤1ppm | In-house |
14. | *Copper | ≤5ppm | EP |
15. | *Iron | ≤2ppm | EP |
16. | Sulphated Ash | ≤0.1% | EP |
17. | Clarity of Solution | Clear | EP |
18. | Color of Solution | ≤BY7 | EP |
19. | *Residual Solvents | Methanol≤0.3% | In-house |
20. | Particle-Size | ≤30% more than 40 mesh. ≥45% between 40 and 80 mesh. |
In-house |
21. | *The total aerobic microbial count(TAMC) |
≤10³cfu/g | ChP |
22. | *The total combined yeasts and moulds count(TYMC) |
≤10²cfu/g | ChP |
23. | *Escherichia coli | Not detected/g | ChP |
24. | *Staphylococcus aureus | Not detected/g | ChP |
25. | *Salmonella | Not detected/10g | ChP |
APPLICATION |