1A03380

5-Hydroxy Lenalidomide

Pharmaceutical Analytical Impurity (PAI)

• Synonym(s): (3-(4-amino-5-hydroxy-1-oxoisoindolin-2-yl)piperidine-2,6-dione)
• Empirical Formula (Hill Notation): C₁₃H₁₃N₃O₄
• CAS Number: 1421593-78-3
• Molecular Weight: 275.26
• MDL number: MFCD18782607
• NACRES: NA.24
• UNSPSC Code: 41116107
• eCl@ss: 25140904

Properties

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: lenalidomide
• manufacturer/tradename: USP
• application(s): pharmaceutical; pharmaceutical; pharmaceutical small molecule
• format: neat
• storage temp.: 2-8°C

Description

General description

Find answers to frequently asked questions on USP products in USP FAQs.

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

Safety Information

• Pictograms: GHS08,GHS07
• Signal Word: Danger
• Hazard Codes: H302,H360D,H373
• Precautionary Statements: P202 - P260 - P264 - P280 - P301 + P312 - P308 + P313
• Hazard Classifications: Acute Tox. 4 Oral - Repr. 1B - STOT RE 2
• Target Organs: Blood
• Storage Class: 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