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About This Item
SMILES string
N(CCOc1ccc(cc1)C(=O)c2c3c([o]c2CCCC)cccc3)(CC)CC
InChI
1S/C25H31NO3/c1-4-7-11-23-24(21-10-8-9-12-22(21)29-23)25(27)19-13-15-20(16-14-19)28-18-17-26(5-2)6-3/h8-10,12-16H,4-7,11,17-18H2,1-3H3
InChI key
PNZXBMCTFUFPLR-UHFFFAOYSA-N
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
amiodarone
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
2-8°C
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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: Amiodarone
Therapeutic Area: Cardiovascular
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
Hazard Classifications
Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Skin Irrit. 2 - STOT RE 2 - STOT SE 3
target_organs
Respiratory system
Storage Class
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Regulatory Information
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