Description

Pomalidomide Impurity 2 CAS NO 1001852-15-8 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 quality control and regulatory compliance. It is primarily required by analytical laboratories, quality assurance departments, and manufacturers within the global pharmaceutical industry to ensure drug purity, safety, and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Pomalidomide drug substance and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• 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 synthesis pathway of Pomalidomide to minimize the formation of this impurity.

Basic Information

Item	Detail
Product Name	Pomalidomide Impurity 2
CAS No.	1001852-15-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pomalidomide Related Compound 2; Pomalidomide Impurity B; Pomalidomide EP Impurity B; Pomalidomide USP Related Compound B; 4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione (Potential IUPAC); CC-4047 Impurity 2; Actimid Impurity 2; (S)-3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione
EINECS	Contact for details

Quality Control

Every batch of Pomalidomide Impurity 2 is manufactured and analyzed under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The container should be kept in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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