| Type: | / |
|---|---|
| Appearance: | Powder |
| Transport Package: | Drum |
|
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| Testing specifications | Standard of corporation | |
| Items | Standard | Results |
| Appearance | Off white crystalline powder | Conforms |
| Assay (By HPLC) | ≥99.5% | 99.9% |
| Ignition residuals | ≤0.3% | 0.04% |
| Loss on drying | ≤0.5% | 0.04% |
| Melting point | 186~189ºC | 186~187ºC |
| Testing specifications:USP 43 | ||
| Items | Standard | Results |
| Characters | White or light yellow crystal or crystalline powder without smell | White crystalline powder without smell. |
| Identification | IR should comply with the reference standard spectrum. Solution main peak retention time should be consist with standard solution main peak retention time. |
IR complies with the reference standard spectrum. Solution main peak retention time should be consist with standard solution main peak retention time. |
| Loss on drying | Not more than 0.2% | 0.06% |
| Residue on ignition | Not more than 0.1% | 0.06% |
| Assay | 98.0~102.0% | 99.76% |
| Organic impurities (HPLC) | Nitrobenzoic acid≤0.2% | ND |
| Benzocaine≤0.2% | ND | |
| Any unspecified impurity≤0.1% | 0.01% | |
| Total impurities≤0.5% | 0.01% | |
| Aniline and P-toluidine(GC) | Aniline ≤10ppm | 1.51ppm |
| P-toluidine≤10ppm | ND | |
| Pb | ≤3ppm | 0.00613ppm |
| Cd | ≤1ppm | 0.00025ppm |
| Hg | ≤0.1ppm | 0.00208ppm |
| As | <1ppm | ND |
| Aerobic plate count | Not more than 103cfu/g | <100cfu/g |
| Yeasts & Molds | Not more than 102cfu/g | <10cfu/g |
| E.Coli | Negative | ND |
| Coliforms | Not more than 10cfu/g | <10cfu/g |
| Salmonelia | Negative | ND |
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