Description

Tamoxifen Citrate USP

Tamoxifen Citrate USP is a pharmaceutical-grade selective estrogen receptor modulator (SERM) used in oral formulations for the treatment and prevention of estrogen receptor-positive breast cancer. It is also indicated for reducing the incidence of breast cancer in high-risk populations and for managing metastatic disease in both pre- and post-menopausal patients. Tamoxifen Citrate is

• A USP-compliant SERM active pharmaceutical ingredient (API)
• A competitive estrogen receptor antagonist in breast tissue
• Indicated for breast cancer treatment, prophylaxis, and metastatic disease
• Suitable for oral solid dosage forms, including tablets and capsules
• Manufactured under Good Manufacturing Practice (GMP) conditions
• Supplied with complete regulatory documentation, including Certificate of Analysis (CoA) and supporting technical data

Tamoxifen Citrate is the Citrate Salt of Tamoxifen, chemically described as (Z)-2-[4-(1,2-Diphenyl-1-butenyl)phenoxy]-n,n-dimethylethanamine citrate (1:1). It functions by competitively binding estrogen receptors, inhibiting estrogen-dependent tumor cell proliferation. In bone and endometrial tissues, Tamoxifen can display partial agonist activity, a property that has clinical implications in long-term use.

In pharmaceutical development, Tamoxifen Citrate USP is used in:

• Adjuvant therapy for early-stage estrogen receptor-positive breast cancer
• Metastatic breast cancer treatment in pre- and post-menopausal women
• Chemoprevention for women at high risk of breast cancer
• Investigational uses, including hormonal management of gynecomastia and fertility disorders

Tamoxifen is extensively metabolized via Cytochrome P450 pathways, notably CYP2D6 and CYP3A4, producing active metabolites such as Endoxifen and 4-Hydroxytamoxifen. Careful attention to formulation and dosing ensures therapeutic efficacy while minimizing the risk of thromboembolic events and endometrial changes.

CarboMer supplies Tamoxifen Citrate USP with rigorous control of impurity profile, polymorphic form, and particle size distribution. Material conforms to USP monograph specifications and is suitable for generic and branded product development.

The API is packaged in sealed, tamper-evident, moisture-protected containers. Available in standard and bulk pack sizes to support formulation development and commercial-scale production. Minimum order quantities (MOQ), lead times, and regulatory documentation support are available upon request.

Each batch is tested per USP requirements for identity, assay, residual solvents, related substances, and microbial limits. Full traceability and Certificates of Analysis (CoA) accompany every shipment.

As with all CarboMer APIs, Tamoxifen Citrate USP is supported by technical formulation consultation, regulatory expertise, and reliable supply chain continuity to help partners bring safe, effective oncology therapies to market.