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Key Documents

1A02470

USP

Aripiprazole Acid Analog

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

(4-((2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy)butanoic acid)

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About This Item

Empirical Formula (Hill Notation):
C13H15NO4
CAS Number:
Molecular Weight:
249.26
UNSPSC Code:
12352106
NACRES:
NA.24

grade

pharmaceutical analytical impurity (PAI)

Agency

USP

API family

aripiprazole

manufacturer/tradename

USP

application(s)

pharmaceutical

format

neat

storage temp.

2-8°C

General description

Aripiprazole Acid Analog 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: Aripiprazole.

For more information about this PAI, visit here.

Application

Aripiprazole Acid Analog (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Features and Benefits

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.

Analysis Note

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.

Other Notes

Sales restrictions may apply.

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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