Description

Pomalidomide Impurity 4 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Pomalidomide. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Pomalidomide-based therapies.

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 & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug product stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Pomalidomide Impurity 4
CAS No.	918314-45-1
Molecular Formula	C13H11N3O4
Molecular Weight	273.24 g/mol
Synonyms	Pomalidomide Related Compound 4; 4-Aminophthalimidoglutarimide; 2-(2,6-Dioxopiperidin-3-yl)-4-aminophthalimidine; 1-Oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline; Pomalidomide Impurity D; Pomalidomide EP Impurity D; CC-4047 Impurity 4
EINECS	Contact for details

Quality Control

Our Pomalidomide Impurity 4 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analysis. We support compliance with ICH guidelines and relevant pharmacopoeial standards for impurity reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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