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grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
octylamine
manufacturer/tradename
USP
application(s)
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
NC(CC(C)(C)C)(C)C
InChI
1S/C8H19N/c1-7(2,3)6-8(4,5)9/h6,9H2,1-5H3
InChI key
QIJIUJYANDSEKG-UHFFFAOYSA-N
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: Clavulanate Potassium
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
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signalword
Danger
hcodes
Hazard Classifications
Acute Tox. 4 Oral - Aquatic Chronic 2 - Eye Dam. 1 - Flam. Liq. 3 - Met. Corr. 1 - Skin Corr. 1C
Clase de almacenamiento
3 - Flammable liquids
flash_point_f
91.4 °F - closed cup
flash_point_c
33 °C - closed cup
Listados normativos
Los listados normativos se proporcionan para los productos químicos principalmente. Para los productos no químicos sólo se puede proporcionar información limitada. Si no hay ninguna entrada, significa que ninguno de los componentes está en la lista. Es obligación del usuario garantizar el uso seguro y legal del producto.
107-45-9
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