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Product Name | GABAPENTIN | Cas No | 60142-96-3 | |
Batch No. | HK11097 | Expiry Date | 26-Jul-23 | |
Manufacturing Date | 26-Jul-20 | Report Date | 30-Jul-20 | |
Quality Standard | EP | Quantuty | 250 kg | |
Analytical Iterms | Specification | Result | ||
Appearance | White or almost white powder | White powder | ||
Solubility | Sparingly soluble in water, very slightly soluble in Methanol,Practically insoluble in heptane | Conforms | ||
Identification | IR | Conforms | ||
HPLC:The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a)for impirity A,B,C. | Conforms | |||
Impurity A,B,C,D | Lactam Impurity ≤0.15% | 0.03% | ||
B-Pregabalin ≤0.15% | 0.04% | |||
Mandelic Acid ≤0.1% | N.D | |||
Lactam Ester ≤0.1% | N.D | |||
Related Substances | Unspecified nonpolar impurity ≤0.1% | 0.036% | ||
Unspecified Polar impurity ≤0.1% | 0.050% | |||
Total Impurities ≤0.5% | 0.118% | |||
Loss on Drying | ≤0.5% | 0.23% | ||
Sulfated Ash | ≤0.1% | 0.03% | ||
Assay By HPLC | 98.0%~102.0% w/w | 99.87% | ||
Conclusion | After inspection the sample meer EP Grade |
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