Appearance | White to pale yellow powder | |
Identity(IR) USP<197K> | Matches reference spectrum | |
Identity(Retention Time) USP<621> | Matches reference retention time | |
UV specific extinction(E1%1cm at 357 nm in ethanol)Spectrophotometry USP<197U> | 1100 ~ 1180 | |
Melting Point USP<741> | 81.0℃ ~ 86.0℃ | |
Loss on Drying USP<731> | Not more than 0.50% | |
Chromatographic purity GC USP<621> | Single Impurity | Not more than 3.0% |
Total Impurities | Not more than 4.5% | |
Assay GC USP<621> | 95.0% ~ 105.0% | |
Residual Solvents GC USP<467> | Methanol | Not more than 3000 ppm |
Toluene | Not more than 890 ppm | |
Microbiology | Total plate count | Not more than 100 CFU/g |
Yeasts & moulds | Not more than 100 CFU/g |