99% ミトキサントロン API ISO 製造業者

What is the stability of Mitoxantrone API and reconstituted solutions?

Our API is stable for 36 months when stored at 2–8°C in the original sealed container, protected from light. Reconstituted IV solutions (0.05–0.5 mg/mL in 0.9% sodium chloride or 5% dextrose) are stable for 24 hours at room temperature and 7 days refrigerated (2–8°C) when protected from light. Extended stability data available upon request.

What is your MOQ and lead time for commercial orders?

The standard MOQ is 10 g for R&D or clinical trial material and 0.1 kg for commercial supply. Lead time is 6–8 days after order confirmation. We maintain limited safety stock for urgent requirements – please inquire.

Do you offer custom particle size or micronization?

Yes. Mitoxantrone API is typically used in solution, so particle size is less critical than for solid dosage forms. However, we can provide micronized material (D90 < 10 μm) if your formulation requires rapid dissolution or suspension. Minimum custom batch is 500 g.

What is the mechanism of action of Mitoxantrone?

Mitoxantrone intercalates into DNA and inhibits topoisomerase II, preventing DNA replication and transcription. It also induces DNA crosslinks and free-radical damage. Unlike anthracyclines (e.g., doxorubicin), it does not form a toxic metabolite (doxorubicinol) that causes chronic cardiotoxicity, though acute cardiac effects and secondary leukemia remain risks. The mechanism in multiple sclerosis is thought to involve immunosuppression (reduction of B‑cells and T‑cells) rather than direct cytotoxicity.

What impurity profile should I expect?

Our API complies with the USP monograph and the Ph. Eur monograph 1029. Known impurities include mitoxantrone diketone (a degradation product), des‑hydroxy Mitoxantrone, and starting-material-related substances. We also screen for potential genotoxic impurities (PGIs) in accordance with ICH M7. Total impurities ≤ 1.5%, with each ≤ 0.5%. Full impurity lists, including retention times and response factors, are included in the DMF.

Is Mitoxantrone still patent‑protected in major markets?

Basic compound patents for Mitoxantrone have expired globally. Novantrone® is off‑patent in the US (FDA Orange Book lists no unexpired exclusivities). However, certain formulations (e.g., liposomal) may have patent protection. For MS indications, no current formulation patents are blocking generic entry. Buyers remain responsible for freedom‑to‑operate analysis.

How do I get a sample for formulation development?

Request a sample via the contact form. We ship 0.1 g samples (sufficient for analytical method development and small‑scale formulation) within 7–10 business days under a material transfer agreement. Samples are free for qualified pharmaceutical manufacturers and outsourcing facilities; you pay shipping. Due to the hazardous nature of Mitoxantrone, we require an active installation with appropriate safety controls in place.

What excipients are compatible with Mitoxantrone API?

The API is soluble in water and aqueous vehicles. Common compatible excipients for injectable formulations include sodium chloride, sodium acetate, acetic acid, lactose, and water for injection. Avoid reducing agents (e.g., ascorbic acid, sodium bisulfite), which may cause degradation. Excipient compatibility screening data is available on request.

Do you support veterinary applications?

Mitoxantrone is used off‑label in veterinary oncology for lymphoma, carcinoma, and sarcoma in dogs. Our API can be supplied with veterinary‑specific documentation if required. Please inquire.