Powder: | Yes |
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Certification: | GMP, HSE, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | Solid |
Purity: | >99% |
Purity Degree: | 99% |
Customization: |
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Items | Standard | Result |
Appearance | Light yellow or yellow powder or crystals , slightly hygroscopic | Complies |
Solubility | Sparingly soluble in water , slightly soluble in ethanol ( 96 per cent ) , practically insoluble in acetone | Complies |
Identification | A:IR,B:HPLC,C:Apparent chlorination identification reaction Complies |
Complies |
Solution of appearance | Clear Color≤GY2 |
Complies |
PH | 3.9 ~ 4.6(0.10g/50ml water) | 4.3 |
Enantiomer | ≤0.15% | ND |
Water | ≤4.5% | 3.7% |
Sulphate ash | ≤0.1% | 0.01% |
Related substances | A Impurity A≤0.15% B Impurity B≤0.15% D Impurity D≤0.15% E Impurity E≤0.15% F Impurity F≤0.15% Unknown impurity≤0.1% Total impurities≤0.3% |
ND ND ND ND 0.01% 0.004% <0.05% |
(GC) Residual solvent |
Acetonotrile≤0.041% Methylene chloride≤0.06% Toluen≤0.089% N, N-dimethylformamide≤0.088% Triethylamine≤0.5% |
ND ND ND ND ND |
Specific rotation | -125°~ -138°(On anhydrous) | -131.8° |
Assay | 98.0 ~ 102.0%(C21H25CIFN3O4)(On anhydrous) |
99.36% |
Conclusion | Complies with EP10.0 standard |
Items |
Standard |
Result |
Appearance |
White to off-white powder |
White powder |
Assay (W/W dry basis) |
≥98.0% |
99.16 % |
Residue on ignition |
<0.5% |
0.256% |
Water (w/w by KF) |
≤1.0% |
0.420% |
pH Value(1% aq.) |
5~9 |
7.28 |
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