Customization: | Available |
---|---|
Powder: | Yes |
Customized: | Non-Customized |
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Testing terms | Specifications | Results |
Appearance | A White or almost white crystalline powder,odorless,slight bitterness | Conforms |
Solubility | Sparingly soluble in water,freely soluble in alcohol;very slightly soluble in methylenechloride | Conforms |
Identification | Infra-red spectrum conforms to that of the reference standard. | Conforms |
Melting point | 168-172ºC | 171ºC |
Loss on drying | ≤0.5% | 0.08% |
Related substances | Impurity J:4-Chloroacetanilide≤10ppm Impurity K:4-Amino phe nol≤50ppm Impurity F:4-Nitrophe nol≤0.05% Any other impurity: ≤0.05% Total of other impurity:≤0.1%ppm |
ND 1.7ppm ND 0.012% 0.025% |
Sulfated ash | ≤0.1% | 0.04% |
Heavy metals | ≤20ppm | <10ppm |
Aerobic bacterial | ≤1000CFU/g | <10CFU/g |
Mold and Yeasts | ≤100CFU/g | <10CFU/g |
Escherichia Coli | None | None |
Endotoxin | <0.15EU/mg | <0.15EU/mg |
Assay | 99.0%-101.0% | 99.4% |