The Gold Standard in HR+ Oncology Therapeutics

Fulvestrant is a steroidal antineoplastic agent and the first-in-class "Pure" Anti-estrogen / SERD. Designed specifically for the treatment of hormone receptor-positive (HR+) advanced or metastatic breast cancer, it functions with zero agonist activity, setting it apart from traditional SERMs like Tamoxifen.

Manufactured under rigorous cGMP protocols at Xi'an Tihealth, our synthetic Fulvestrant API ($C_{32}H_{47}F_5O_3S$, MW: $606.77\ g/mol$) is precisely engineered for the formulation of long-acting intramuscular (IM) oily injections. We provide a highly stable, consistently crystalline powder with an ultra-low impurity profile, empowering global oncology drug manufacturers to meet stringent regulatory standards.

API Specifications

• ✓ Purity (HPLC): ≥ 99.5%
• ✓ Single Impurity: ≤ 0.10%
• ✓ Appearance: White to off-white powder
• ✓ Compliance: USP / EP Standards
• ✓ Storage: 2°C to 8°C (Nitrogen-flushed)

Optimized Lipophilic Dissolution

Fulvestrant is highly lipophilic and virtually insoluble in water. Our API is meticulously crystallized to ensure optimal solubility and stability when suspended in complex oily vehicles (e.g., castor oil, ethanol, and benzyl benzoate) for 250mg/5mL IM depot injections.

ICH Q3A/B Impurity Control

Utilizing advanced LC-MS and GC methodologies, we maintain absolute control over process-related impurities and residual solvents. Individual unknown impurities are strictly capped at ≤ 0.10%, ensuring long-term oncological safety.

Full Regulatory Support (DMF)

Seamlessly integrate our API into your generic or novel drug applications. We provide comprehensive Tech Packs, including MOA, 24-month stability data, and support for DMF (Drug Master File) and CEP submissions.

Critical Cold-Chain & Stability Notice

Fulvestrant API is sensitive to thermal fluctuations and oxidative degradation. It is supplied in nitrogen-flushed, airtight, and light-protected packaging. Mandatory continuous storage at 2°C to 8°C is required to maintain its validated 24-month potency.

Tamoxifen is a Selective Estrogen Receptor Modulator (SERM) possessing partial agonist activity, which can inadvertently stimulate endometrial tissue. Fulvestrant is a "pure" antiestrogen; it lacks entirely any agonist activity, resulting in a cleaner safety profile without the risk of uterine hypertrophy.

Absolutely. While its primary indication is for commercial 250mg IM injections, its status as the benchmark SERD makes our ultra-pure API highly sought after by R&D institutions developing novel orally bioavailable SERDs and targeted protein degraders (PROTACs) in oncology discovery.

Yes. Fulvestrant is clinically the backbone for combination therapies involving CDK4/6 inhibitors (like Palbociclib, Ribociclib, and Abemaciclib). Our API guarantees the pharmacokinetic reliability required when formulating treatments aimed at overcoming endocrine resistance.