推荐产品
等级
pharmaceutical analytical impurity (PAI)
Agency
USP
制造商/商品名称
USP
应用
pharmaceutical
包装形式
neat
储存温度
2-8°C
相关类别
一般描述
[6-Methyl-4-phenylchromanol (25 mg) (6-Methyl-4-phenylchroman-2-ol)] - CAS [209747-04-6] (usp.org)6-Methyl-4-Phenylchromanol 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: Tolterodine tartrate.
Therapeutic Area: Renal.
For more information about this PAI, visit here.
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: Tolterodine tartrate.
Therapeutic Area: Renal.
For more information about this PAI, visit here.
应用
6-Methyl-4-Phenylchromanol (USP PAI) is intendedfor use in analytical testing to detect, identify, and measure pharmaceuticalimpurities.
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.
储存分类代码
11 - Combustible Solids
WGK
WGK 3
闪点(°F)
Not applicable
闪点(°C)
Not applicable
法规信息
新产品
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