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維達列汀

序號 項目 Item 指標 Specification
1 外觀 Appearance 白色或類白色結晶性粉末
White oralmost white crystalline powder
2 鑒別 Identification IR:  corresponds to the standard
UV:  corresponds to the standard
3 比旋度(º)
Specific optical rotation(º)
1.0% methanol(20ºC), +96~+100
3 含量  Assay (%)(dry bass) 99.0~101.0
4 水分 Water(%) ≤0.5
5 灰分Sulphated ash(%) ≤0.1
6 相關物質(HPLC)(%)
Related substances
impurity  A ≤0.1
impurity  B ≤0.1
impurity  C ≤0.1
Max individual impurity ≤0.1
Total impurities ≤0.5
7 重金屬 Heavy Metals(as Pb)(ppm) ≤20
8 殘留溶劑 Residual solvent(%) 2-butanone ≤0.5
 
 
 
 
 
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