Description

Pirarubicin Hydrochloride is a semi-synthetic anthracycline antibiotic and a key derivative of doxorubicin, designed to enhance therapeutic efficacy while mitigating cardiotoxicity. This compound is a critical active pharmaceutical ingredient (API) for the formulation of injectable chemotherapeutic agents. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of oncology treatments, particularly for bladder, breast, and ovarian cancers.

Application

• Oncological Pharmaceutical Manufacturing: Primary use as the Active Pharmaceutical Ingredient (API) in injectable chemotherapy formulations.
• Bladder Cancer Therapy: Key component in intravesical instillation treatments for superficial bladder cancer.
• Solid Tumor Research: Used in preclinical and clinical research for investigating treatments against breast, ovarian, and other solid tumors.
• Drug Delivery System Development: Serves as a model compound in R&D for liposomal, nanoparticle, or other targeted delivery platforms to improve biodistribution.
• Mechanistic Studies: Utilized in biochemical research to study DNA intercalation, topoisomerase II inhibition, and free radical generation.
• Reference Standard: Serves as a high-purity chemical reference standard for analytical method development and quality control in pharmaceutical labs.

Basic Information

Product Name	Pirarubicin Hydrochloride
CAS No.	95343-20-7
Molecular Formula	C32H37NO12 · HCl
Molecular Weight	664.10 g/mol (for free base: 627.64)
Synonyms	4'-O-Tetrahydropyranyl Doxorubicin Hydrochloride; THP-Doxorubicin HCl; THP-ADM; Pirarubicin HCl; (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
EINECS	Contact for details

Quality Control

Our Pirarubicin Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, identification by IR and UV-Vis spectroscopy, and stringent control of related substances and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with cGMP and ICH Q7 guidelines for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature of 15-25°C or under refrigeration at 2-8°C as specified. The 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	Orange-red to 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)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 5.0 EU/mg (for injectable grade)
Sterility	Sterile (for aseptic fill grade, tested accordingly)

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