Description

Pomalidomide Impurity 10 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) pomalidomide. This high-purity reference material is critical for ensuring the safety and efficacy of pharmaceutical products by enabling accurate identification and quantification of this specific impurity. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes for pomalidomide-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Pomalidomide Impurity 10 in API and finished drug product batches.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of pomalidomide.
• Quality Control & Release Testing: Used in routine QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines to ensure batch-to-batch consistency and compliance.
• Stability Studies: Employed to track the formation of this impurity during forced degradation and long-term stability studies of pomalidomide drug substances and products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of pomalidomide under various stress conditions.

Basic Information

Product Name	Pomalidomide Impurity 10
CAS No.	92792-46-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Aminophthalimidoglutarimide; 4-Amino-2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione; Pomalidomide 4-Amino Impurity; Pomalidomide Related Compound 10; 4-Amino Derivative of Pomalidomide; CC-4047 Impurity 10; Actimid Impurity 10
EINECS	Contact for details

Quality Control

Every batch of Pomalidomide Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. We support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an 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)	≥ 95.0%
Assay	97.0% - 102.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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