Description

Doxorubicin Hydrochloride is a potent anthracycline antibiotic and a cornerstone chemotherapeutic agent. Its primary value lies in its ability to intercalate with DNA and inhibit topoisomerase II, leading to the disruption of DNA replication and synthesis in rapidly dividing cells. This mechanism makes it a critical raw material for pharmaceutical manufacturers producing injectable formulations to treat a wide range of cancers, including breast cancer, leukemia, and lymphoma. Global demand is driven by its established efficacy in both first-line and combination chemotherapy regimens.

Application

• Oncological Pharmaceutical Manufacturing: Primary active pharmaceutical ingredient (API) in injectable chemotherapy drugs for treating solid tumors and hematological malignancies.
• Liposomal Formulation Production: Key component in the synthesis of advanced drug delivery systems like liposomal doxorubicin, which targets tumors more selectively to reduce cardiotoxicity.
• Cancer Research & Development: Essential reference standard and biochemical tool for in vitro and in vivo studies on apoptosis, drug resistance, and novel anti-cancer mechanisms.
• Generic Drug Synthesis: Bulk active ingredient for the production of cost-effective, bioequivalent generic oncology medications, improving global access to treatment.
• Combination Therapy Preparations: Used in compounding with other chemotherapeutic agents (e.g., cyclophosphamide, vincristine) to create potent combination regimens.
• Bioconjugate & Targeted Therapy Development: Serves as the cytotoxic payload in the development of antibody-drug conjugates (ADCs) and other targeted cancer therapies.

Basic Information

Product Name	Doxorubicin Hydrochloride
CAS No.	25316-40-9
Molecular Formula	C₂₇H₂₉NO₁₁ • HCl
Molecular Weight	579.98 g/mol
Synonyms	Doxorubicin HCl; Adriamycin Hydrochloride; (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione hydrochloride; 14-Hydroxydaunomycin Hydrochloride; Hydroxydaunorubicin Hydrochloride; FI 106; NSC 123127
EINECS	Contact for details

Quality Control

Our Doxorubicin Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and microbiological quality. We support compliance with cGMP, ICH Q7 guidelines, and relevant regulatory frameworks (e.g., US FDA, EMA) for pharmaceutical active ingredients.

Storage

Preserve in a tightly closed container, protected from light. Due to its properties of being strictly light-sensitive and easily oxidized, the product must be stored under an inert atmosphere (e.g., nitrogen) in a freezer at -20°C or below. The container should be kept in a dry, well-ventilated area designated for potent cytotoxic substances. Allow the sealed container to reach room temperature before opening to prevent condensation and moisture ingress.

Specification

Item	Specification
Appearance	Orange-red, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 3.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 5.0 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/ USP <61>

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