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Merck

1A00370

USP

R-Levetiracetam Hydroxybutyramide Analog

Pharmaceutical Analytical Impurity (PAI)

Synonim(y):

R-Levetiracetam Hydroxybutyramide Analog, ((R)-N-(1-amino-1-oxobutan-2-yl)-4-hydroxybutanamide)

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Informacje o tej pozycji

Wzór empiryczny (zapis Hilla):
C8H16N2O3
Numer CAS:
Masa cząsteczkowa:
188.22
NACRES:
NA.24
UNSPSC Code:
41116107
eCl@ss:
25140904
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grade

pharmaceutical analytical impurity (PAI)

agency

USP

API family

levetiracetam

manufacturer/tradename

USP

application(s)

pharmaceutical small molecule

format

neat

storage temp.

-10 to -25°C

General description

Find answers to frequently asked questions on USP products in USP FAQs.
R-Levetiracetam Hydroxybutyramide 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: Levetiracetam
Therapeutic Area: Psychiatrics

Application

R-Levetiracetam Hydroxybutyramide 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.
USP issued SDS can be found here
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Klasa składowania

11 - Combustible Solids

Co się dzieje?

WGK 3

Temperatura zapłonu (°F)

Not applicable

Temperatura zapłonu (°C)

Not applicable



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Certyfikaty analizy (CoA)

Lot/Batch Number

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