Description

Daunorubicin Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anticancer drug Daunorubicin by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on oncology drug development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Daunorubicin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels, ensuring every batch of Daunorubicin API meets stringent pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Used to track the formation of degradation products in Daunorubicin under various stress conditions (e.g., heat, light, humidity) as part of ICH stability-indicating studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization of the drug substance.
• Research on Degradation Pathways: Facilitates research into the chemical stability and degradation mechanisms of anthracycline-class chemotherapeutic agents.

Basic Information

Product Name	Daunorubicin Impurity 8
CAS No.	1010447-40-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Daunorubicin Related Compound 8; Daunorubicin EP Impurity H; Daunorubicin USP Impurity; 13-Dihydrodaunorubicin; 7-Deoxydaunorubicinone; Daunomycinone, 7-deoxy-; Daunorubicin Degradant; Daunorubicin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Daunorubicin Impurity 8 (CAS 1010447-40-1) is manufactured under a quality management system and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our products are characterized using advanced techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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 product 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	Red to reddish-brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.