Description

Pomalidomide Impurity 10 is a designated impurity reference 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 benchmark in chromatographic and spectroscopic methods. 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: Primary use as a certified impurity standard for HPLC, UPLC, and LC-MS analysis in quality control laboratories.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods for Pomalidomide API and related drug products.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Pomalidomide.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization and control data.
• Research and Development: Aids in the synthesis pathway investigation and impurity profiling during the R&D phase of Pomalidomide and its generic versions.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability and identification marker in routine batch release testing of the API.

Basic Information

Product Name	Pomalidomide Impurity 10
CAS No.	1547162-41-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pomalidomide Related Compound 10; Pomalidomide Impurity; CC-4047 Impurity 10; 4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione derivative (specific isomer); Actimid Impurity; Pomalyst Impurity; (S)-3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione derivative
EINECS	Contact for details

Quality Control

Our Pomalidomide Impurity 10 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual and total limits
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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