99% Mitoxantrone API Of ISO Manufacturer
Mitoxantrone is a synthetic anthracenedione antineoplastic agent that intercalates into DNA and inhibits topoisomerase II, leading to cell cycle arrest and apoptosis. Unlike doxorubicin, it lacks the amino sugar moiety and produces significantly less cardiotoxicity, making it a preferred option for certain patient populations.
The API also has documented off‑label activity in breast cancer, non‑Hodgkin lymphoma, and pediatric acute lymphoblastic leukemia.
Our Mitoxantrone API is produced in a cGMP‑compliant facility with dedicated high‑potency API (HPAPI) containment systems, including closed isolators and negative pressure environments. Each batch is tested for related substances, residual solvents, heavy metals, and bacterial endotoxins in accordance with USP/EP.
Why Choose Us As Your Mitoxantrone Supplier?
#1. High Purity With 99%
Although our quality standard for mitoxantrone raw material is 98%, our HPLC results for every batch exceed 99%.
If you need reference substances with a purity of more than 99.9%, further purification will take weeks and cost much more.
#2. Low-MOQ with Fast Shipping
OCTAGONCHEM is a supplier willing to work with minor- to medium-sized business owners. We are happy to repack to meet your needs.
For example, our MOQ is 1 Gram to start, but if you only need 100mg for your research, we can also do that, and we will make sure we ship it out within 3~4 days after your order confirmation.
Mitoxantrone API Applications and Specifications
Technical Documents Download
MSDS (Ask Us For It When You Need It)
Method Of Analysis for Mitoxantrone Hydrochloride Salt By USP43
Application:
For Pharmaceutical Manufacturers
Use our Mitoxantrone API in finished dosage forms:
Intravenous injection (2 mg/mL, 20 mg/10 mL, 25 mg/12.5 mL vials) – the standard formulation for all indications.
Intravenous infusion concentrates – for dilution in 0.9% sodium chloride or 5% dextrose.
Liposomal formulations (investigational) – for altered pharmacokinetics and reduced cardiotoxicity.
For Compounding Pharmacies
Prepare patient‑specific IV solutions when commercial vials are unavailable or customized dosing is required:
Body surface area‑adjusted doses for pediatric oncology (e.g., 5–10 mg/m²)
Reduced doses for elderly MS patients (e.g., 8 mg/m² every 3 months)
Dilutions for intraventricular or intrathecal use (off‑label, with appropriate protocols)
Product Name: Mitoxantrone APIs
Appearance: A dark-blue powder
Solubility: Slightly soluble or almost insoluble in water
Cas Number: 65271-80-9 (70476-82-3 for dihydrochloride salt)
Molecular Formula: C22H28N4O6
Molecular Weight: 444.5 g/mol
Chemical Name: 1,4-dihydroxy-5,8-bis[2-(2-hydroxyethylamino)ethylamino]anthracene-9,10-dione
HS Code: 2922509099 (Other amino alcohol phenols, amino acid phenols-其他氨基醇酚、氨基酸酚)
Suitability for shipment by courier as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Chemical Grade
Purity or Assay: 99%
Standards: Current Enterprise/USP Standards
Certificates available: ISO
Documents Available: COA/MSDS
Supply Capability: 1KG per month
MOQ: 1 Gram
Lead Time: 3~4 days for quantities less than 50 Grams, 4~5 days for orders less than 200 G.
Stock Status: Over 300 G
Shipping Temperature: Room temperature
Storage: 2~8 °C (Long-Term)
Technical Data:
PH value: 8.5~9.5 for base, 3.0~5.5 for hydrochloride salt
Related substances: Total impurities: NMT2.0%, Single impurity: NMT1.0%
Water: NMT1.0%
Sulfated ash: NMT0.2%
Heavy metals: NMT20ppm
Assay: 97.0%~102.0%
If you are searching for Mitoxantrone API cas 65271-80-9 (Mitoxantrone HCl Cas 70476-82-3), please get in touch with us directly by email or message us.
OCTGONCHEM is a professional supplier of mitoxantrone API in China with ready stocks and competitive prices; contact us directly for a free quote.
FAQs About Our Mitoxantrone (Hydrochloride) APIs
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.
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