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About This Item
InChI key
RAFHKEAPVIWLJC-IQDWRYOJSA-N
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
SMILES string
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
grade
pharmaceutical analytical impurity (PAI)
agency
USP
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
General description
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
Application
Features and Benefits
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.
Analysis Note
signalword
Warning
hcodes
Hazard Classifications
Aquatic Acute 1 - Aquatic Chronic 1 - STOT SE 2
target_organs
Liver
Storage Class
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Regulatory Information
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