等级
pharmaceutical analytical impurity (PAI)
Agency
USP
蒸汽密度
4.7 (vs air)
蒸汽压
1 mmHg ( 39 °C)
自燃温度
932 °F
expl. lim.
9.5 %
制造商/商品名称
USP
沸点
103-104 °C/15 mmHg (lit.)
mp
32-35 °C (lit.)
应用
pharmaceutical small molecule
包装形式
neat
储存温度
-10 to -25°C
SMILES字符串
COC(=O)c1ccc(C)cc1
InChI
1S/C9H10O2/c1-7-3-5-8(6-4-7)9(10)11-2/h3-6H,1-2H3
InChI key
QSSJZLPUHJDYKF-UHFFFAOYSA-N
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一般描述
Methyl p-toluate 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: Celecoxib
Therapeutic Area: Analgesics
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: Celecoxib
Therapeutic Area: Analgesics
应用
Methyl p-toluate (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：
Warning
危险分类
Eye Irrit. 2 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
靶器官
Respiratory system
储存分类代码
11 - Combustible Solids
WGK
WGK 2
闪点(°F)
No data available
闪点(°C)
No data available
法规信息
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