InChI key
KWYHDKDOAIKMQN-UHFFFAOYSA-N
SMILES string
CN(C)CCN(C)C
InChI
1S/C6H16N2/c1-7(2)5-6-8(3)4/h5-6H2,1-4H3
grade
pharmaceutical analytical impurity (PAI)
agency
USP
expl. lim.
9.08 %
manufacturer/tradename
USP
refractive index
n20/D 1.4179 (lit.)
mp
−55 °C (lit.)
density
0.775 g/mL at 20 °C (lit.)
application(s)
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
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General description
Tetramethyl Ethylene Diamine is a USP Pharmaceutical Analytical Impurity (PAI).
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
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
Tetramethyl Ethylene Diamine (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Features and Benefits
USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
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.
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
These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.
signalword
Danger
hcodes
Hazard Classifications
Acute Tox. 3 Inhalation - Acute Tox. 4 Oral - Eye Dam. 1 - Flam. Liq. 2 - Skin Corr. 1B
存储类别
3 - Flammable liquids
wgk
WGK 1
flash_point_f
61.7 °F - closed cup
flash_point_c
16.5 °C - closed cup
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