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Flutamide

Flutamide CAS 13311-84-7 | Premium API Manufacturer & Supplier | Henan Haitian Biotechnology

Flutamide API (CAS 13311-84-7)

High-Purity Nonsteroidal Antiandrogen | GMP-Certified Manufacturer & Supplier — Henan Haitian Biotechnology Co., Ltd.

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Product Overview

Flutamide — chemically known as 2-methyl-N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide — is a first‑generation, non‑steroidal antiandrogen (NSAA) that acts as a competitive antagonist of the androgen receptor (AR)[reference:0]. It is primarily indicated for the management of locally confined (Stage B2‑C) and metastatic (Stage D2) prostate carcinoma, often in combination with LHRH agonists or surgical castration[reference:1].

At Henan Haitian Biotechnology Co., Ltd., we leverage over a decade of pharmaceutical manufacturing expertise to produce Flutamide API in strict accordance with USPEPGMP standards. Every batch is backed by a full Certificate of Analysis (CoA), ensuring consistent quality for research, clinical, and industrial applications.

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Flutamide Powder
Light Yellow Crystalline

Technical Specifications

ParameterSpecification
CAS Number13311-84-7
EINECS236-341-9
Molecular FormulaC11H11F3N2O3
Molecular Weight276.21 g/mol
AppearanceLight yellow to pale yellow crystalline powder
Purity≥ 99.0% (HPLC)
Melting Point110 – 114 °C (lit.)
SolubilityPractically insoluble in water; freely soluble in ethanol, acetone
Storage2 – 8 °C, sealed, protected from light
Quality StandardUSP, EP, BP, CP
Typical Packing1 kg / 5 kg / 25 kg fiber drums or aluminum foil bags

Data sourced from pharmacopoeia monographs and internal quality control. Request a CoA for batch‑specific results.

Mechanism of Action

Flutamide and its active metabolite 2‑hydroxyflutamide competitively bind to androgen receptors (AR) in prostate tissue and other target cells. This blocks the binding of endogenous androgens — testosterone and its more potent metabolite dihydrotestosterone (DHT) — thereby inhibiting androgen‑driven transcription and cell proliferation[reference:2].

Key Pharmacodynamics:
• Competitive AR antagonism with Ki ≈ 55 nM for the active metabolite.
• Prevents nuclear translocation and DNA binding of the AR complex.
• Suppresses testosterone‑stimulated prostatic DNA synthesis.
• Reduces prostate volume and PSA levels in responsive patients.

Clinical Applications & Indications

🎯 Advanced Prostate Cancer

Previously untreated or hormone‑refractory advanced prostate carcinoma. Used alone (with or without orchiectomy) or combined with LHRH agonists for combined androgen blockade (CAB).

💊 Benign Prostatic Hyperplasia

Off‑label use for symptomatic BPH, reducing androgen‑mediated prostate growth and ameliorating urinary symptoms.

🔬 Research Use

Widely employed in in‑vitro and in‑vivo models to study androgen‑dependent signaling, gene expression, and prostate cancer biology.

🧴 Off‑Label Applications

Investigated for acne vulgaris, hirsutism, and other hyperandrogenism‑related conditions.

Why Choose Henan Haitian Biotechnology?

🏭 GMP‑Certified Manufacturing

Our facilities hold veterinary GMP accreditation from China’s Ministry of Agriculture, with clean‑room processing and ISO‑aligned quality systems.

🔎 Full Analytical Support

Each shipment includes a comprehensive CoA, MSDS, and, when required, residual solvent and heavy metal reports. Third‑party testing is available on request.

🌾 Integrated Production Chain

Operating 10‑plus production lines across 30,000 m², we control every step from intermediate synthesis to final micronization, ensuring supply stability and cost efficiency.

🌍 Global Logistics

We export to over 30 countries with temperature‑controlled shipping, customs‑ready documentation, and flexible Incoterms (FOB, CIF, DDP).

Packaging & Storage

Flutamide is hygroscopic and light‑sensitive. Standard packaging configurations:

  • 1 kg / 5 kg — Aluminum foil bags inside a fiber drum, vacuum‑sealed with desiccant.
  • 25 kg — HDPE drum with double‑layer LDPE liner, tamper‑evident seal.
  • Custom packaging (e.g., 500 g R&D packs, palletized bulk) available upon request.

Storage Conditions: Keep tightly closed in a dry, cool (2–8 °C) environment protected from light. Under proper storage, solid‑state Flutamide remains stable for up to 36 months[reference:3].

Frequently Asked Questions

❓ What is Flutamide CAS 13311‑84‑7 used for?

Flutamide is a nonsteroidal antiandrogen primarily used to treat advanced prostate cancer by blocking androgen receptors. It is also used off‑label for benign prostatic hyperplasia (BPH), acne vulgaris, and hirsutism[reference:4].

❓ How pure is Henan Haitian’s Flutamide API?

Our Flutamide API meets USP/EP/BP standards with a purity of ≥ 99.0% (HPLC). Each batch is certified by a CoA and manufactured under GMP guidelines.

❓ What is the minimum order quantity (MOQ)?

The typical MOQ is 1 kg for sample evaluation. Bulk orders of 25 kg and above receive competitive volume pricing. Contact us for tailored quotations.

❓ How should Flutamide powder be stored?

Store in a tightly sealed container in a cool, dry place away from direct light at 2–8 °C for long‑term stability. Avoid exposure to moisture and heat[reference:5].

❓ Does Henan Haitian Biotechnology ship Flutamide internationally?

Yes. We export to North America, Europe, Southeast Asia, the Middle East, and Africa. All shipments comply with international pharmaceutical logistics regulations.

Get in Touch

Ready to discuss your Flutamide API requirements? Reach out to our dedicated sales team for pricing, samples, or technical inquiries.

🏢 Company: Henan Haitian Biotechnology Co., Ltd.

📍 Address: No.6 Feiyue Road, Shangqiu Development Zone, Henan, China

📞 Tel: +86-370-3166333

📧 Email: haitianbiotech@gmail.com | info@haitianbio.cn

🌐 Website: haitianbio.com

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Disclaimer: This product is intended for research and pharmaceutical manufacturing purposes only. It is not for direct human or veterinary therapeutic use without appropriate formulation and regulatory approval.

Name Flutamide
Synonyms 2-Methyl-N-(4-nitro-3-[trifluoromethyl]phenyl)propanamide

Molecular Formula C11H11F3N2O3
Molecular Weight 276.21
CAS Registry Number 13311-84-7
EINECS 236-341-9

Flutamide is a nonsteroidal antiandrogen. In animal studies, flutamide demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g. castration. Elevations of plasma testosterone and estradiol levels have been noted following flutamide administration.

Flutamide is a nonsteroidal antiandrogen that blocks the action of both endogenous and exogenous testosterone by binding to the androgen receptor. In addition Flutamide is a potent inhibitor of testosterone-stimulated prostatic DNA synthesis. Moreover, it is capable of inhibiting prostatic nuclear uptake of androgen.