Description

Pomalidomide Impurity 6 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient, Pomalidomide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and stability studies for the production of high-quality pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Pomalidomide Impurity 6 in drug substance and drug product batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of Pomalidomide.

Basic Information

Product Name	Pomalidomide Impurity 6
CAS No.	1795373-54-4
Molecular Formula	C13H11N3O4
Molecular Weight	273.25 g/mol
Synonyms	4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione; 4-Amino-2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione; Pomalidomide 4-Amino Impurity; Pomalidomide Related Compound 6; 4-Aminopomalidomide; UNII-9H0K8F0W4R; Pomalidomide Impurity F (4-Amino)
EINECS	Contact for details

Quality Control

Our Pomalidomide Impurity 6 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under inert atmosphere.

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)	Individual unknown 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.