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Tamoxifen Citrate Powder (CAS 54965-24-1) is one of the most widely used and longest-established anti-estrogen antitumor raw materials in global clinical practice, especially effective on the endocrine therapy of breast cancer. Featuring high purity, high stability and bioavailability, it is applied in the R&D and large-scale production of oral preparations, providing standard and accessible treatment options for patients with hormone receptor-positive breast cancer.
Technical Specifications
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Product Name |
Tamoxifen Citrate Powder |
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Synonyms |
Tamoxifen Citrate API,Tamoxifen Citrate Raw Material |
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Characteristics |
White to off-white crystalline powder |
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CAS Number |
54965-24-1 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C32H37NO8 |
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Package |
Technical Package |
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Storage |
Store at 4℃, sealed storage, away from moisture |
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Structure |
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Product Features
Tamoxifen Citrate API is a non-steroidal anti-estrogen active ingredient. It selectively binds to estrogen receptors in breast cancer cells, and also blocks estrogen-mediated signal transduction. In tumor cells, it inhibits DNA and RNA synthesis, slows proliferation, and induces cell cycle arrest and apoptosis, which is highly targeted to hormone receptor-positive breast cancer. The active ingredient is dominated by Z-isomer, with strong anti-estrogen activity, clear clinical efficacy and complete safety data, making it a first-line basic raw material for global clinical use.
Produced with optimized synthesis and multi-stage purification processes, it has stable purity of ≥99.0%. Key indicators encompassing impurities, isomers, residual solvents and heavy metals fully comply with ChP, USP and EP standards, satisfying global registration requirements. The closed and standardized production process effectively avoids cross-contamination and degradation, with small batch differences and excellent long-term storage stability, ensuring consistent quality of finished preparations.
It has good fluidity, uniform particle size and stable chemical properties, meeting the process requirements of tablets, capsules, oral solutions and other dosage forms, with stable dissolution and high bioavailability. Tamoxifen Citrate Raw Material is suitable for industrial continuous production to improve efficiency.
Full-Cycle Quality Control & Consistent Quality
End-to-End Traceability Management
A complete traceability chain is established from raw material procurement, synthesis, purification, drying and crushing to finished product packaging and release. Each batch of Tamoxifen Citrate API is accompanied by a complete COA report with real-time recording of key process parameters, ensuring traceable sources, controllable processes and verifiable quality.
Stringent Testing Standards
In strict compliance with ICH guidelines and international pharmacopoeia standards, the product undergoes comprehensive testing including assay, related substances, isomer ratio, loss on drying, melting point, pH, residual solvents and microbial limits. Pharmaceutical-grade quality for every batch is ensured.
Stable Process and Continuous Optimization
The applied synthetic routes are mature and controllable enough to reduce by-products and improve yield and purity. Through routine process validation, stability studies, and quality audits, production and testing methods are continuously optimized to guarantee long-term, stable supply and meet high standards by global customers.
Comprehensive Compliance System
The quality system covers R&D, production, testing, storage and transportation, complying with international pharmaceutical API management regulations. Complete registration documents including HNMR, LC-MS, IR, impurity analysis and stability data are available to support global drug registration and compliant sales.
Application Scenarios
Tamoxifen Citrate API is indicated for adjuvant therapy after surgery, salvage therapy for recurrent or metastatic breast cancer in premenopausal and postmenopausal women with hormone receptor-positive breast cancer, as well as chemoprevention in high-risk populations, covering the full cycle of clinical management.
Clinical Preparation Production
Tamoxifen Citrate API is used to produce tamoxifen citrate tablets, oral suspensions, sustained-release capsules and other compliant preparations in strict accordance with CP, USP, EP standards. It supports adjuvant therapy to reduce recurrence risk, salvage therapy to control disease progression, and chemoprevention to reduce incidence in high-risk groups, covering the full cycle of breast cancer management.
Formulation R&D and Process Scale-Up
Tamoxifen Citrate Raw Material is used for formulation screening (tablets, capsules, oral solutions), dissolution optimization (improving dissolution and bioavailability) and process scale-up from lab trials to pilot and commercial production, helping pharmaceutical companies optimize workflows, reduce costs and shorten time-to-market.
Scientific Research and New Drug Development
Tamoxifen Citrate Powder (CAS 54965-24-1) is used for basic research on estrogen receptor signaling, tumor cell proliferation, drug resistance mechanisms to deepen molecular understanding of breast cancer; for combination therapy research of chemotherapy, targeted therapy and endocrine therapy to optimize clinical regimens; and for R&D of nano-formulations and targeted delivery systems to expand clinical applications and improve patient experience.
Packaging and Transportation
Standard Protective Packaging
Double-layer packaging with pharmaceutical-grade sealed bags and aluminum foil bags, plus moisture-proof buffers and sealed drums, effectively blocks light, moisture and leakage to maintain stability of Tamoxifen Citrate API during storage and transportation. Customized packaging is available for lab trials, pilot and large-scale production.
Standard Logistics and Temperature Control
Transportation is carried out under dry and dark conditions with full tracking to ensure safe and on-time delivery. Complete customs documents, COA and certificates of origin are provided for international orders to meet customs and regulatory inspection requirements.
Global Delivery Capacity: Backed by a mature foreign trade logistics network, products can be shipped to global pharmaceutical markets quickly with flexible scheduling to ensure uninterrupted supply.
Our Advantages
Stable Capacity and In-Stock Supply
Large-scale production lines guarantee consistent output. Regular specifications are in stock for prompt delivery of urgent orders, short lead times and long-term strategic cooperation.
High-Quality Assurance
Produced by pharmaceutical-grade standards, each batch is released only after strict testing. Purity, impurities and stability outperform industry averages, reducing formulation development risks.
Comprehensive Foreign Trade and Compliance Support
With extensive export experience, we provide full documentation, compliance materials, COA and spectra to assist with registration, filing and customs clearance for efficient, safe and compliant procurement.
Cost-Effectiveness and Long-Term Partnership
Scale production and supply chain optimization deliver sustainable competitiveness. Bulk orders of Tamoxifen Citrate Powder are supported to reduce costs and achieve long-term win-win cooperation.
FAQ
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