Procurar Série Farmacêutica, Material De Vedação De Borracha , Graxa De Silicone no diretório Industry Directory, fabricante / fornecedor / Fábrica confiável a partir de China
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Test items |
Requirements |
Results |
Description |
A White or off-white crystalline powder; odorless; tasted bitter. |
Complies |
Solubility |
Slightly soluble in water, very slightly soluble in dehydrated alcohol, soluble in DMF and very soluble DMSO. |
Complies |
Identification |
|
|
A. IR |
A: Conform to reference standard |
Conforms |
B. Chemical Property |
B: Dissolve 0.1g the sample with 10ml water, add 5ml dinitro-phenyl-hydrazine, should have marron precipitate. |
Positive |
C. HPLC |
C: The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation |
Conforms |
Loss on drying |
≤ 1.0%. |
0.21% |
Residue on ignition |
≤ 0.1%. |
0.07% |
Heavy metals |
≤ 0.002%. |
Complies |
Chloride |
≤ 0.002%. |
Complies |
|
Impurities by HPLC Any impurity(Max) Total impurities |
≤ 0.1%. ≤ 0.3%. |
0.042% 0.08% |
|
Residual solvents Ethyl acetate Alcohol DMSO |
≤ 0.5%. ≤ 0.5%. ≤ 0.5%. |
Complies Complies Complies |
Assay (HPLC) |
98.5%~102.0% |
99.80% |
Grupo de Produto : Série Farmacêutica
