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Merck
CN

1A03380

USP

5-Hydroxy Lenalidomide

Pharmaceutical Analytical Impurity (PAI)

Synonym(s):

(3-(4-amino-5-hydroxy-1-oxoisoindolin-2-yl)piperidine-2,6-dione)

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About This Item

Empirical Formula (Hill Notation):
C13H13N3O4
CAS Number:
1421593-78-3
Molecular Weight:
275.26
MDL number:
MFCD18782607
UNSPSC Code:
12352200

Key Documents

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grade

pharmaceutical analytical impurity (PAI)

Agency

USP

API family

lenalidomide

manufacturer/tradename

USP

application(s)

pharmaceutical small molecule

format

neat

storage temp.

2-8°C

Related Categories

General description

5-Hydroxy Lenalidomide 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: Lenalidomide


Therapeutic Area: Hematology and Oncology

Application

5-Hydroxy Lenalidomide (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

Pictograms

Health hazardExclamation mark
GHS08,GHS07

Signal Word

Danger

Hazard Statements

H302,H360D,H373

Hazard Classifications

Acute Tox. 4 Oral - Repr. 1B - STOT RE 2

Target Organs

Blood

Storage Class Code

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Regulatory Information

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