General Information

Tamoxifen Impurities and Tamoxifen 

Daicel Pharma provides a wide selection of unique Tamoxifen impurities, including Bis-tamoxifen, Tamoxifen Impurity A, Tamoxifen Impurity D, Tamoxifen Impurity F, Tamoxifen N-Oxide, and Z-Chlorolefin. These impurities are vital in evaluating the active pharmaceutical ingredient Tamoxifen’s quality, stability, and biological safety. Moreover, Daicel Pharma can synthesize Tamoxifen impurities based on specific customer requirements, ensuring reliable delivery worldwide.

Tamoxifen [CAS: 10540-29-1] is a triphenylethylene derivative that treats breast cancer in adults with estrogen receptor-positive tumors. It is also an adjuvant therapy for early-stage estrogen receptor-positive breast cancer in adults.

Tamoxifen: Use and Commercial Availability  

Tamoxifen, a non-steroidal weak estrogen, treats breast cancer at all stages in specific patients. It is for the palliative treatment of premenopausal women with estrogen receptor-positive (ER-positive) disease. Tamoxifen also lowers the risk of invasive breast cancer following surgery and radiation in adult women diagnosed with ductal carcinoma in situ.

Tamoxifen is available under Nolvadex and Soltamox, which contain the active ingredient, Tamoxifen.

Tamoxifen Structure and Mechanism of Action

The chemical name of Tamoxifen is 2-[4-[(1Z)-1,2-Diphenyl-1-buten-1-yl]phenoxy]-N,N-dimethylethanamine. Its chemical formula is C₂₆H₂₉NO, and its molecular weight is approximately 371.5 g/mol.

The anti-estrogenic effects of Tamoxifen compete with estrogen for the binding sites in breast tissues.

Tamoxifen Impurities and Synthesis

During the synthesis¹ and storage of Tamoxifen, various impurities such as related substances, degradation products, and residual solvents can form. It is crucial to diligently monitor and control these impurities to ensure the medication’s safety, effectiveness, and overall quality.

Daicel Pharma provides a comprehensive Certificate of Analysis (CoA) for Tamoxifen impurity standards, including Bis-tamoxifen, Tamoxifen Impurity A, Tamoxifen Impurity D, Tamoxifen Impurity F, Tamoxifen N-Oxide, and Z-Chlorolefin. These impurities are produced strictly with current Good Manufacturing Practices (cGMP). The CoA comprises detailed characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity, offering a thorough understanding of the impurity profile. Upon request, Daicel can also supply 13C-DEPT data for further characterization.

Additionally, Daicel Pharma possesses the technical expertise to synthesize any unknown impurities or degradation products of Tamoxifen.