Description

Daunorubicin Impurity 1 CAS NO 51996-45-3 is a specified impurity of the anthracycline antineoplastic drug Daunorubicin. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical chemistry. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method validation, stability studies, and ensuring the purity and safety of the active pharmaceutical ingredient (API).

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Daunorubicin API.
• Essential for analytical method development and validation (HPLC, LC-MS) in pharmaceutical quality control.
• Critical component in stability studies to monitor degradation profiles of Daunorubicin formulations.
• Used in pharmacopeial testing to comply with regulatory standards (e.g., USP, EP, ICH guidelines).
• Supports research and development of Daunorubicin and related anthracycline compounds.
• Employed in regulatory submissions to demonstrate comprehensive impurity profiling.

Basic Information

Product Name	Daunorubicin Impurity 1
CAS No.	51996-45-3
Molecular Formula	C27H29NO10
Molecular Weight	527.52 g/mol
Synonyms	13-Dihydrodaunorubicin; 13-Dihydrodaunomycin; Daunorubicinol; Daunomycinol; (8S,10S)-8-Acetyl-10-[(2S,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,8,11-trihydroxy-1-methoxy-9,10-dihydro-7H-tetracene-5,12-dione; 7-Deoxydaunorubicinol; Daunorubicin metabolite
EINECS	Contact for details

Quality Control

Every batch of Daunorubicin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling via advanced chromatographic techniques. Certificates of Analysis (COA) containing detailed results for each parameter are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C under an inert atmosphere. This product is strictly light-sensitive (protect from all light exposure) and easily oxidized (store under inert atmosphere).

Specification

Item	Specification
Appearance	Red to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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