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Items of Analysis | Standard of Analysis | Test Results | |
Appearance | White to off-white crystalline powder | Conforms | |
Identification | HPLC retention time correspond to WRS under assay item |
Conforms | |
Loss on drying | ≤0.5% | 0.36% | |
Residue on Ignition | ≤0.5% | 0.40% | |
Heavy metals | ≤20ppm | <20ppm | |
Related substances | Any single impurity | ≤0.5% | <0.5% |
Total impurities | ≤1.0% | <1.0% | |
Assay(HPLC) | ≥99.0% | 99.3% | |
Microbial | Aerobic Plate Count | ≤1000cfu/g | Conforms |
Yeast&moulds | ≤100cfu/g | Conforms | |
E.coli | Negative | Conforms | |
Salmonella | Negative | Conforms | |
Conclusion | Conforms to Factory Standard |
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