Description

Daunorubicin Hydrochloride is a potent anthracycline antibiotic and antineoplastic agent, widely recognized for its critical role in chemotherapy regimens. Its primary value lies in its ability to intercalate with DNA and inhibit topoisomerase II, making it a cornerstone in the treatment of specific hematological malignancies. This high-purity active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers and research institutions developing and producing injectable oncology medications.

Application

• Oncological Pharmaceutical Manufacturing: As a key active pharmaceutical ingredient (API) in the formulation of injectable chemotherapeutic drugs for acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL).
• Biomedical Research: Used as a critical tool compound in cancer biology studies to investigate mechanisms of apoptosis, DNA damage, and drug resistance in vitro and in vivo.
• Drug Discovery & Development: Serves as a reference standard or a lead compound for the synthesis and evaluation of novel anthracycline analogs with improved efficacy or reduced cardiotoxicity.
• Clinical Trial Material (CTM): Supplied under stringent quality protocols for use in the production of investigational medicinal products for clinical trials.
• Analytical Reference Standard: Utilized in quality control laboratories for the identification and assay of daunorubicin hydrochloride in finished drug products via HPLC, UV, or other spectroscopic methods.

Basic Information

Product Name	Daunorubicin Hydrochloride
CAS No.	23541-50-6
Molecular Formula	C27H29NO10 • HCl
Molecular Weight	563.99 g/mol
Synonyms	Daunomycin Hydrochloride; Rubidomycin Hydrochloride; Cerubidine Hydrochloride; (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside hydrochloride; Daunorubicini hydrochloridum; 5,12-Naphthacenedione, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, hydrochloride, (8S,10S)-; Antibiotic RP 13057 hydrochloride; NSC 82151 hydrochloride; FI 6339 hydrochloride
EINECS	Contact for details

Quality Control

Our Daunorubicin Hydrochloride is manufactured and tested under a strict quality management system. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Specifications typically align with pharmacopeial monographs. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting key parameters such as assay, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature or under refrigeration (2-8°C) as specified. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	Red-orange to red crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 3.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Specific Rotation	+248° to +258° (c = 0.1 in methanol)
Bacterial Endotoxins	< 5.0 EU/mg (if applicable)

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