Description

Idarubicin Hydrochloride is a potent semi-synthetic anthracycline antibiotic derivative, widely recognized for its critical role in oncology. Its primary value lies in its mechanism of action as a topoisomerase II inhibitor, which enables effective DNA intercalation and disruption of cancer cell replication. This makes it an essential active pharmaceutical ingredient (API) for the formulation of injectable chemotherapy drugs, primarily targeting acute leukemias and other hematological malignancies. Pharmaceutical manufacturers and research institutions globally rely on a consistent, high-purity supply for drug development and production.

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the key active ingredient in injectable chemotherapy formulations for treating acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

• Clinical Research & Drug Development: Serves as a reference standard and investigational compound in preclinical and clinical studies for novel cancer therapies and combination regimens.

• Generic Drug Production: Essential for manufacturers producing generic versions of branded idarubicin hydrochloride injectable solutions.

• Hospital & Compounding Pharmacy Use: Used in specialized settings for preparing patient-specific doses, though primarily handled by large-scale manufacturers.

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  | Product Name | Idarubicin Hydrochloride |
  | CAS No. | 57852-57-0 |
  | Molecular Formula | C₂₆H₂₇NO₉ • HCl |
  | Molecular Weight | 533.96 g/mol |
  | Synonyms | 4-Demethoxydaunorubicin Hydrochloride; Idamycin PFS (brand name component); Zavedos (brand name component); 4-DMDR HCl; (7S,9S)-9-Acetyl-7-[(2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyloxan-2-yl]oxy-6,9,11-trihydroxy-7,8,9,10-tetrahydrotetracene-5,12-dione hydrochloride; Idarubicini hydrochloridum; NSC 256439 |
  | EINECS | Contact for details |

  Quality Control

  Our Idarubicin Hydrochloride is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is tested to meet stringent specifications for identity, purity, potency, and impurity profiles, 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 requirements for global markets.

  Storage

  Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), or as indicated on the label. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, well-ventilated area.

  Specification

  Item	Specification
  Appearance	Orange-red, crystalline powder
  Identification (IR)	Conforms to reference spectrum
  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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
  Residual Solvents (GC)	Complies with ICH Q3C guidelines
  Heavy Metals	≤ 20 ppm
  Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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