| Customization: | Available |
|---|---|
| Function: | Blood System Agents |
| Certification: | GMP |
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| Tests | Specifications | Results |
| Characters | White or off white crystalline powder | Complies |
| Identification | IR:similar to Reference Standard | Complies |
| Appearance of solution | powder | Complies |
| Specific Rotation | -127°to -132° | -131° |
| Loss on Drying | ≤0.5% | 0.06% |
| Sulphated Ash | ≤0.2% | 0.03% |
| Heavy metals | ≤0.002% | Complies |
| PH | 2.0 - 2.6 | 2.3 |
| Related Compouds | 1. Single Impurity ≤1.0% 2. Sum of Impurity≤2.0% |
Undetected Undetected |
| Assay(Anhydrous) | 98.0% -101.5% | 100.2% |
| Item | Requirements | Test Results |
| Description | White to off- white crystalline powder | Complies |
| Water | ≤0.20% | 0.06% |
| Light absorption(50mg/ml,440nm,4cm) | ≤0.0015 | Complies |
| Total impurities | ≤0.60% | 0.14% |
| Other individual impurity | ≤0.10% | 0.01% |
| Relative retention time at about 0.4 impurity | ≤0.30% | 0.01% |
| Relative retention time at about 0.90 impurity | ≤0.20% | 0.11% |
| Total residual solvents | ≤0.3% | 0.14% |
| Assay(On the anhydrous basis) | 98.0%~102.0% | 99.6% |
| TESTS | Specification | RESULTS |
| Appearance | White or off-white crystalline powder | White crystalline powder |
| Identification | IR absorption spectrum of a potassium bromide dispersion of the sample is concordant with that of a similar preparation of Nevirapine USP RS/working hard | conforms |
| HPLC the retention time of the majir peak of the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard prepartion,as obtained in the assay | conforms | |
| Solubility | Practically insoluble in water,slightly insoluble in ethanol and methanol | conforms |
| water | ≤0.2% w/w | 0.11% |
| Residue on ignition | ≤0.1% | 0.03% |
| Heavy metals | ≤0.001% | <0.001% |
| Nevirapine related compound A | ≤0.2% | 0.01% |
| Nevirapine related compound B | ≤0.2% | 0.01% |
| Nevirapine related compound C | ≤0.2% | 0.004% |
| Another individual unspecified impurity | ≤0.1% | 0.01% |
| Total impurities | ≤0.6% | 0.03% |
| Organic volatile impurities | O-Xylene ≤2170ppm | ND |
| Dimethylformamide≤880ppm | ND | |
| Methanol ≤3000ppm | 9ppm | |
| ethylacetate≤5000ppm | 195ppm | |
| Assay (HPLC) | C15H14N4O 98.0% ~102.0% | 100.3% |
| Conclusion | Comply with the USP31 standard | |
| Item | Requirements | Test Results |
| Description | White to off- white crystalline powder | Complies |
| Light Absorption | Not more than 0.015(440nm,4cm cell, 50mg/ml) | Complies |
| Water | ≤0.20% | 0.06% |
| Light absorption(50mg/ml,440nm,4cm) | ≤0.0015 | Complies |
| Total impurities | ≤0.60% | 0.14% |
| Other individual impurity | ≤0.10% | 0.01% |
| Relative retention time at about 0.4 impurity | ≤0.30% | 0.01% |
| Relative retention time at about 0.90 impurity | ≤0.20% | 0.11% |
| Total residual solvents | ≤0.3% | 0.14% |
| Ethanol | ≤0.20% | 0.14% |
| Assay(On the anhydrous and solvent-free basis) | 98.0%~102.0% | 99.6% |
| ITEMS | SPECIFICATIONS | RESULTS |
| Appearance | White crystalline powder, soluble in water, very slightly soluble in acetone and in alcohol | Conforms |
| Identification | IR | Conforms |
| Appearance of solution | Solution is clear and colorless | Conforms |
| Acidity | To 10ml of solution S1 add 0.1ml of phenolphthalein solution R1,the solution is colourless,not more than 0.7 ml of 0.01M sodium hydroxide is required to change the colour of the indicator to pink |
Conforms |
| PH | 5.0~7.0 | 6.3 |
| Loss on drying | ≤05% | 0.08% |
| Residue on Ignition | ≤0.3% | 0.3% |
| Transmittance | ≥97% | 97.2% |
| Water-insoluble matter | ≤0.5% | 0.21% |
| Limit of 1,1-cyclobutane- dicarboxylic acid |
≤0.5% | N.D |
| Chromatographic purity: Individual impurity: All impurities: |
≤0.25% ≤0.5% |
0.077% 0.19% |
| Platinum content | 52.0% - 53.0% | 52.33% |
| Chlorides | ≤100ppm | Conforms |
| Ammonium | ≤100ppm | Conforms |
| Silver | ≤10ppm | Conforms |
| Soluble barium | ≤10ppm | Conforms |
| Assay | 98.0%-102.0% | 99.2% |
| Conclusiion | This product complied with the standard of USP 32 & EP5 | |
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