Description

Pixantrone Impurity B is a designated impurity standard of the antineoplastic agent Pixantrone. This high-purity reference material is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for analytical method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Pixantrone Impurity B in Pixantrone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure API batches comply with stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Pixantrone to minimize the formation of this impurity.

Basic Information

Product Name	Pixantrone Impurity B
CAS No.	144510-94-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Pixantrone Related Compound B; BBR 2778 Impurity B; 1H-Benz[de]isoquinoline-1,3(2H)-dione, 5-[[2-[2-(2-aminoethyl)aminoethyl]amino]ethyl]amino]-2,2-dimethyl-; 5-[[2-[2-(2-Aminoethyl)aminoethyl]amino]ethyl]amino]-2,2-dimethyl-1H-benz[de]isoquinoline-1,3(2H)-dione
EINECS	Contact for details

Quality Control

Our Pixantrone Impurity B is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via spectroscopic methods (MS, NMR), to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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 COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	Off-white to yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
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.