99% Mitoxantrona API del fabricante ISO
Mitoxantrona 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.
Nuestro API de mitoxantrona 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.
¿Por qué elegirnos como su proveedor de mitoxantrona?
#1. Alta pureza con 99%
Although our quality standard for mitoxantrone raw material is 98%, our HPLC results for every batch exceed 99%.
Si necesita sustancias de referencia con una pureza de más de 99,9%, la purificación adicional tardará semanas y costará mucho más.
#2. Pedido mínimo bajo con envío rápido.
OCTAGONCHEM es un proveedor dispuesto a trabajar con pequeñas y medianas empresas. Con gusto reempacamos para satisfacer sus necesidades.
Por ejemplo, nuestro MOQ es 1 gramo para comenzar, pero si solo necesita 100 mg para su investigación, también podemos hacerlo y nos aseguraremos de enviarlo dentro de los 3 a 4 días posteriores a la confirmación de su pedido.
Mitoxantrone API Applications and Specifications
Descargar documentos técnicos
MSDS (Pídanosla cuando la necesite)
Método de análisis de la sal de clorhidrato de mitoxantrona según la USP43
Solicitud:
Para fabricantes farmacéuticos
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.
Para farmacias de compuestos
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)
Nombre del producto: API de mitoxantrona
Apariencia:Un polvo azul oscuro
Solubilidad:Ligeramente soluble o casi insoluble en agua.
Número CAS:65271-80-9 (70476-82-3 para sal de diclorhidrato)
Fórmula molecular:C22H28N4O6
Peso molecular:444,5 g/mol
Nombre químico: 1,4-dihidroxi-5,8-bis[2-(2-hidroxietilamino)etilamino]antraceno-9,10-diona
Código HS: 2922509099 (Los demás aminoalcoholes fenoles, aminoácidos fenoles-其他氨基醇酚、氨基酸酚)
Suitability for shipment by courier as common goods: Adecuado. Se puede enviar por vía aérea sin ningún problema, como si fuera una mercancía común.
Calificación: Grado químico
Pureza o Ensayo: 99%
Normas:Estándares actuales de empresa/USP
Certificados disponibles:ISO
Documentos disponibles: Certificado de autenticidad/ficha de datos de seguridad
Capacidad de suministro:1 kg por mes
Cantidad mínima de pedido:1 gramo
Plazo de entrega:3~4 días para cantidades inferiores a 50 gramos, 4~5 días para pedidos inferiores a 200 gramos.
Estado del stock:Más de 300 G
Temperatura de envío:Temperatura ambiente
Almacenamiento: 2~8 °C (largo plazo)
Datos técnicos:
Valor de pH: 8,5~9,5 para base, 3,0~5,5 para sal de hidrocloruro
Sustancias relacionadas: Impurezas totales: NMT2.0%, Impureza única: NMT1.0%
Agua: NMT1.0%
Cenizas sulfatadas: NMT0.2%
Metales pesados: NMT20ppm
Ensayo: 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 es un proveedor profesional de API de mitoxantrona en China con existencias listas y precios competitivos; contáctenos directamente para obtener una cotización gratuita.
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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