1A01050
USP
6-Methyl-4-Phenylchromanol
Pharmaceutical Analytical Impurity (PAI)
Synonim(y):
(6-Methyl-4-phenylchroman-2-ol)
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About This Item
Polecane produkty
klasa czystości
pharmaceutical analytical impurity (PAI)
agency
USP
producent / nazwa handlowa
USP
Zastosowanie
pharmaceutical
format
neat
temp. przechowywania
2-8°C
Opis ogólny
[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.
Zastosowanie
6-Methyl-4-Phenylchromanol (USP PAI) is intendedfor use in analytical testing to detect, identify, and measure pharmaceuticalimpurities.
Cechy i korzyści
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.
Kod klasy składowania
11 - Combustible Solids
Klasa zagrożenia wodnego (WGK)
WGK 3
Temperatura zapłonu (°F)
Not applicable
Temperatura zapłonu (°C)
Not applicable
Certyfikaty analizy (CoA)
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