Tamoxifen

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Bis-tamoxifen

  • CAT Number DCTI-C-1280
  • CAS Number 1346606-51-6
  • Molecular Formula C49H49NO2
  • Molecular Weight 683.94

Tamoxifen Impurity A

  • CAT Number DCTI-C-1317
  • CAS Number NA
  • Molecular Formula C26H29NO (Free base) C28H30F3NO3 (TFA Salt)
  • Molecular Weight 371.52 (Free base) 485.54 (TFA Salt)

Tamoxifen Impurity D

  • CAT Number DCTI-C-1417
  • CAS Number 197251-11-9
  • Molecular Formula C25H27NO
  • Molecular Weight 357.5

Tamoxifen Impurity F

  • CAT Number DCTI-C-1281
  • CAS Number 31750-48-8
  • Molecular Formula C25H27NO
  • Molecular Weight 357.5

Tamoxifen N-Oxide

  • CAT Number DCTI-C-1278
  • CAS Number 75504-34-6
  • Molecular Formula C26H29NO2
  • Molecular Weight 387.52

Z-Chlorolefin

  • CAT Number DCTI-C-1279
  • CAS Number 97818-83-2
  • Molecular Formula C24H23ClO
  • Molecular Weight 362.9

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 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.

 

References
FAQ's

Frequently Asked Questions

Analytical Methods such as High-Performance Liquid Chromatography (HPLC) can detect impurities in Tamoxifen.

The presence of impurities in Tamoxifen can affect patient safety. The type and level of these impurities can lead to adverse effects or diminish the effectiveness of the medication.

Methanol is used to achieve optimal solubility and separation of Tamoxifen impurities.

Tamoxifen impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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