Description

Doxorubicin Ep Impurity C Hbr is a high-purity chemical reference standard, specifically identified as an impurity of the critical anticancer agent Doxorubicin. This compound is essential for pharmaceutical research and development, serving as a critical marker for ensuring the purity, safety, and efficacy of doxorubicin-based drug substances and products. It is primarily required by analytical laboratories, quality control units, and regulatory affairs departments within the global pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify the Epimer C impurity in Doxorubicin HCl active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies and Forced Degradation: Employed in stability-indicating assay methods to monitor impurity levels during drug substance and product stability testing under various stress conditions.
• Quality Control and Batch Release Testing: Essential for routine quality control testing to ensure that doxorubicin batches meet stringent pharmacopeial specifications (e.g., USP, EP, JP) for impurity limits.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research into Degradation Pathways: Aids in research studies to understand the degradation mechanisms and kinetics of doxorubicin, supporting improved formulation and packaging strategies.

Basic Information

Product Name	Doxorubicin Ep Impurity C Hbr
CAS No.	60873-68-9
Molecular Formula	C27H29NO11 • HBr
Molecular Weight	600.43 g/mol (for free base C27H29NO11)
Synonyms	(8S,10S)-8-Glycoloyl-10-[(2S,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,8,11-trihydroxy-1-methoxy-7,8,9,10-tetrahydrotetracene-5,12-dione Hydrobromide; Doxorubicin EP Impurity C Hydrobromide; Doxorubicin Related Compound C HBr; Adriamycin Impurity C HBr; 14-Hydroxydaunomycin Epimer C Hydrobromide; Doxorubicin HCl Impurity C (HBr Salt); Doxorubicin Hydrochloride Impurity C Hydrobromide
EINECS	Contact for details

Quality Control

Every batch of Doxorubicin Ep Impurity C Hbr is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and related substances. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopeias (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and light-sensitive; prolonged exposure to moisture, heat, or light should be avoided to maintain stability and purity.

Specification

Item	Specification
Appearance	Red to orange-red powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Assay (on dried basis)	95.0% - 105.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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