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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
expl. lim.
9.08 %
manufacturer/tradename
USP
refractive index
n20/D 1.4179 (lit.)
bp
120-122 °C (lit.)
mp
−55 °C (lit.)
density
0.775 g/mL at 20 °C (lit.)
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
SMILES string
CN(C)CCN(C)C
InChI
1S/C6H16N2/c1-7(2)5-6-8(3)4/h5-6H2,1-4H3
InChI key
KWYHDKDOAIKMQN-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
1 of 1
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description BioReagent, suitable for electrophoresis, ≥99.0% | description ≥99.5%, purified by redistillation | description ReagentPlus®, 99% |
| manufacturer/tradename USP | manufacturer/tradename - | manufacturer/tradename - | manufacturer/tradename - |
| grade pharmaceutical analytical impurity (PAI) | grade - | grade - | grade - |
| format neat | format - | format - | format - |
| application(s) pharmaceutical small molecule | application(s) - | application(s) - | application(s) - |
| storage temp. -10 to -25°C | storage temp. - | storage temp. - | storage temp. - |
| mp −55 °C (lit.) | mp −55 °C (lit.) | mp −55 °C (lit.) | mp −55 °C (lit.) |
Signalwort
Danger
Gefahrencodes
Hazard Classifications
Acute Tox. 3 Inhalation - Acute Tox. 4 Oral - Eye Dam. 1 - Flam. Liq. 2 - Skin Corr. 1B
Lagerklasse
3 - Flammable liquids
Was ist los?
WGK 1
Flammpunkt (°F)
61.7 °F - closed cup
Flammpunkt (°C)
16.5 °C - closed cup
Zulassungslistungen
Zulassungslistungen werden hauptsächlich für chemische Produkte erstellt. Für nicht-chemische Produkte können hier nur begrenzte Angaben gemacht werden. Kein Eintrag bedeutet, dass keine der Komponenten gelistet ist. Es liegt in der Verantwortung des Benutzers, die sichere und legale Verwendung des Produkts zu gewährleisten.
110-18-9
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