1A03810
USP
RIFAMYCIN O
Pharmaceutical Analytical Impurity (PAI)
别名:
Rifamycin O, (4-O-(Carboxymethyl)-1-deoxy-1,4-dihydro-4-hydroxy-1-oxo-rifamycin gamma-Lactone)
等级
pharmaceutical analytical impurity (PAI)
Agency
USP
制造商/商品名称
USP
应用
pharmaceutical small molecule
包装形式
neat
储存温度
-10 to -25°C
SMILES字符串
N1C2=CC5(OCC(=O)O5)c3c4c(c(c(c3C2=O)O)C)OC(O\C=C/C(C(C(C(C(C(C(C(\C=C/C=C(\C1=O)/C)C)O)C)O)C)OC(=O)C)C)OC)(C4=O)C
InChI
1S/C39H47NO14/c1-17-11-10-12-18(2)37(48)40-24-15-39(51-16-26(42)53-39)29-27(33(24)46)32(45)22(6)35-28(29)36(47)38(8,54-35)50-14-13-25(49-9)19(3)34(52-23(7)41)21(5)31(44)20(4)30(17)43/h10-15,17,19-21,25,30-31,34,43-45H,16H2,1-9H3,(H,40,48)/b11-10-,14-13-,1
InChI key
RAFHKEAPVIWLJC-IQDWRYOJSA-N
一般描述
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Rifaximin
Therapeutic Area: Antibiotics
应用
特点和优势
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.
分析说明
警示用语:
Warning
危险声明
危险分类
Aquatic Acute 1 - Aquatic Chronic 1 - STOT SE 2
靶器官
Liver
储存分类代码
11 - Combustible Solids
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
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