1A00400
USP
四甲基乙二胺
Pharmaceutical Analytical Impurity (PAI)
别名:
1,2-双(二甲基氨基)乙烷, TEMED, TMEDA
等级
pharmaceutical analytical impurity (PAI)
Agency
USP
expl. lim.
9.08 %
制造商/商品名称
USP
折射率
n20/D 1.4179 (lit.)
沸点
120-122 °C (lit.)
mp
−55 °C (lit.)
密度
0.775 g/mL at 20 °C (lit.)
应用
pharmaceutical small molecule
包装形式
neat
储存温度
-10 to -25°C
SMILES字符串
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
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一般描述
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
应用
Tetramethyl Ethylene Diamine (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
特点和优势
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.
分析说明
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.
警示用语：
Danger
危险分类
Acute Tox. 3 Inhalation - Acute Tox. 4 Oral - Eye Dam. 1 - Flam. Liq. 2 - Skin Corr. 1B
储存分类代码
3 - Flammable liquids
WGK
WGK 1
闪点(°F)
61.7 °F - closed cup
闪点(°C)
16.5 °C - closed cup
法规信息
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