Description

Pomalidomide Related Compound 9 Triflate is a high-purity chemical reference standard and synthetic intermediate of significant importance in pharmaceutical research and development. Its primary value lies in its role as a key impurity marker and building block for the synthesis and analytical validation of the active pharmaceutical ingredient, Pomalidomide. This compound is essential for quality control laboratories, analytical chemists, and process development scientists working within the pharmaceutical and biotechnology sectors to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification and quantification of related substances in Pomalidomide drug substance and finished dosage forms, critical for HPLC and LC-MS methods.
• Analytical Method Development & Validation: Used as a system suitability standard and for establishing detection/quantification limits in compliance with ICH Q2(R1) and USP guidelines.
• Process Chemistry Research: Acts as a crucial intermediate or a model compound in route scouting and optimization for the synthesis of Pomalidomide and its analogues.
• Stability Studies: Employed in forced degradation studies to understand the degradation pathways of Pomalidomide and to validate the stability-indicating capability of analytical procedures.
• Regulatory Documentation: Provides essential data for regulatory filings (e.g., FDA, EMA) to define impurity profiles and justify specification limits as per ICH Q3A and Q3B.
• Academic & Contract Research: Utilized in academic institutions and CROs (Contract Research Organizations) for research into immunomodulatory drugs and related chemical biology.

Basic Information

Product Name	Pomalidomide Related Compound 9 Triflate
CAS No.	2093388-21-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-Amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione Triflate; Pomalidomide Triflate Impurity; Pomalidomide Related Substance 9; Pomalidomide Triflate Derivative; CC-4047 Related Compound 9 Triflate; (3-(4-Amino-1,3-dioxoisoindolin-2-yl)piperidine-2,6-dione) Trifluoromethanesulfonate; Pomalidomide Trifluoromethanesulfonate Analog
EINECS	Contact for details

Quality Control

Our Pomalidomide Related Compound 9 Triflate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity analysis, NMR and MS confirmation of structure, and determination of residual solvents and moisture content. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with relevant standards for pharmaceutical reference materials. Our quality commitment supports your needs for reliable and consistent data in regulatory submissions and internal quality assurance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The product may be hygroscopic and/or light-sensitive; handle and store under inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 1.0%
Total Impurities	≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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