Description

Pomalidomide Impurity 3 is a specified impurity of the active pharmaceutical ingredient Pomalidomide, a critical immunomodulatory drug. This compound is essential for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of pomalidomide-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pomalidomide API and finished dosage forms.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure compliance with stringent pharmacopeial limits (e.g., ICH Q3A/B, USP, EP).
• Stability Studies: Used to track the formation and levels of this impurity during forced degradation and long-term stability testing of drug products.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway of Pomalidomide to minimize impurity formation.

Basic Information

Product Name	Pomalidomide Impurity 3
CAS No.	2635-64-5
Molecular Formula	C13H11N3O4
Molecular Weight	273.25 g/mol
Synonyms	1-Oxo-1,3-dihydro-2H-isoindole-2-carboxylic acid; Phthaloyl glycine; N-Phthaloylglycine; 2-(1,3-Dioxoisoindolin-2-yl)acetic acid; Phthalimidoacetic acid; 2-Phthalimidoglycolic acid; Glycine, N-phthaloyl-; 2635-64-5
EINECS	220-140-5

Quality Control

Our Pomalidomide Impurity 3 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and consistency, meeting the rigorous standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, NMR, and mass spectrometry for structural confirmation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.