Doxorubicin Hydrochloride, a potent anthracycline antibiotic, stands as a cornerstone in modern chemotherapy regimens. Known by various trade names for its finished drug forms, the Active Pharmaceutical Ingredient (API) is a vital white crystalline powder identified by CAS number 25316-40-9. Its mechanism of action involves intercalating DNA and inhibiting topoisomerase II, crucial processes for rapidly dividing cancer cells, making it effective against a wide spectrum of malignancies.

The clinical utility of Doxorubicin Hydrochloride spans across numerous cancer types, including breast cancer, lymphomas (such as Hodgkin's and non-Hodgkin's lymphoma), leukemias (like acute lymphoblastic leukemia and acute myeloid leukemia), sarcomas, and various solid tumors. Its broad-spectrum activity underscores its importance in oncology, often used alone or in combination therapies.

Given its critical application in treating life-threatening diseases, the quality and purity of Doxorubicin Hydrochloride API are paramount. Suppliers must adhere to stringent quality control measures, ensuring the product meets high standards. Typical specifications demand an assay of more than 99%, confirming its purity and potency. The physical state as a solid white crystalline powder indicates its refined form, ready for downstream processing into various pharmaceutical formulations like injections or liposomal preparations.

Regulatory compliance is a non-negotiable aspect of Doxorubicin Hydrochloride production and supply. Manufacturers are expected to follow Good Manufacturing Practices (GMP), and the API may require certification from bodies like the FDA (Food and Drug Administration) for market access in certain regions and ISO standards for quality management systems. These certifications provide assurance of the API's consistency, quality, and safety profile.

The stability and handling of Doxorubicin Hydrochloride API are also critical considerations. It is sensitive to light and heat and requires appropriate storage conditions, typically in a cool, dry place protected from light, to maintain its stability and efficacy over its shelf life, which can extend to 24 months or longer under correct storage. Proper packaging, such as cardboard drums or cartons designed to protect the sensitive powder, is essential during transport and storage.

The global demand for Doxorubicin Hydrochloride API remains significant due to the ongoing prevalence of cancers treatable with this agent. As a result, securing a reliable supply chain is crucial for pharmaceutical companies producing the final drug product. This involves navigating a complex market to identify manufacturers with proven track records and robust production capacities.

For pharmaceutical developers and manufacturers seeking to purchase or buy Doxorubicin Hydrochloride API, thorough due diligence is essential. Evaluating potential suppliers based on their quality certifications (GMP, ISO, potentially site-specific audits), production capacity, consistency of supply, and technical support is vital. Requesting samples for independent testing is a standard practice to verify the quality claimed by the supplier or manufacturer.

Understanding the market price trends for Doxorubicin Hydrochloride API is also important for procurement strategies. Prices can fluctuate based on global demand, production costs, raw material availability, and supplier location. Comparing quotes from multiple qualified sources helps in securing competitive pricing without compromising on quality. Factors like Minimum Order Quantity (MOQ), often measured in grams or kilograms, also influence the unit price.

Finding a reputable manufacturer or supplier of Doxorubicin Hydrochloride API requires careful consideration of their experience in producing potent and sensitive APIs. A supplier with extensive export experience and established quality systems can provide greater assurance of product reliability and compliance with international shipping and regulatory requirements. When you look to buy Doxorubicin Hydrochloride, prioritize transparency in documentation and technical support.

In conclusion, Doxorubicin Hydrochloride API (CAS 25316-40-9) is a critical pharmaceutical ingredient with widespread use in cancer treatment. Its efficacy and safety depend heavily on its purity and quality, necessitating strict adherence to global pharmaceutical standards. Sourcing this API requires partnering with a trustworthy manufacturer or supplier capable of providing high-quality material consistently and reliably. Understanding the market dynamics and the importance of quality certifications are key steps for companies looking to purchase this essential API.