Description

Pomalidomide Impurity 1 is a specified impurity and degradation product of the active pharmaceutical ingredient Pomalidomide. This compound is critical for analytical reference standards used in pharmaceutical research, development, and quality control processes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Pomalidomide drug substance and finished products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) protocols.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry and process development to understand and control impurity formation during API synthesis.

Basic Information

Product Name	Pomalidomide Impurity 1
CAS No.	1001852-14-7
Molecular Formula	C₁₃H₁₁N₃O₄
Molecular Weight	273.25 g/mol
Synonyms	4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione; 3-(4-Amino-1,3-dioxoisoindolin-2-yl)piperidine-2,6-dione; Pomalidomide Impurity A; Pomalidomide Related Compound A; 4-Aminothalidomide; CC-4047 Impurity 1; UNII-8V6U6S2J8Q
EINECS	Contact for details

Quality Control

Our Pomalidomide Impurity 1 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results, ensuring compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The compound is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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