1A03220
USP
(S)-2-AMINO-4-MORPHOLINOBUTANOIC ACID HYDROCHLORIDE
Pharmaceutical Analytical Impurity (PAI)
Synonyme(s) :
(S)-2-amino-4-morpholinobutanoic acid, hydrochloride
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About This Item
Code UNSPSC :
12352106
Nomenclature NACRES :
NA.24
Produits recommandés
Qualité
pharmaceutical analytical impurity (PAI)
Agence
USP
Fabricant/nom de marque
USP
Application(s)
pharmaceutical
Format
neat
Température de stockage
2-8°C
Description générale
(S)-2-AMINO-4-MORPHOLINOBUTANOIC ACID 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.
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.
For more information about this PAI, visit here.
Application
(S)-2-AMINO-4-MORPHOLINOBUTANOIC ACID HYDROCHLORIDE (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.
Caractéristiques et avantages
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.
Remarque sur l'analyse
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.
Autres remarques
Sales restrictions may apply.
Code de la classe de stockage
11 - Combustible Solids
Classe de danger pour l'eau (WGK)
WGK 3
Point d'éclair (°F)
Not applicable
Point d'éclair (°C)
Not applicable
Certificats d'analyse (COA)
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