General Information

Anastrozole Impurities and Anastrozole 

Daicel Pharma synthesizes high-quality Anastrozole impurities, including Alpha-Desmethyl Anastrozole, Anastrozole Diacid, and Anastrozole Dimer Impurity. These impurities are essential for evaluating the quality, stability, and safety of Anastrozole, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Anastrozole impurities for global delivery to meet the specific needs of our customers.

Anastrozole [CAS: 120511-73-1] is a non-steroidal aromatase inhibitor to treat postmenopausal women with estrogen receptor-positive breast cancer. It resembles the chemical structure of paclitaxel.

Anastrozole: Use and Commercial Availability  

Anastrozole is a medication to treat breast cancer in postmenopausal women. Specifically, it is an adjunct therapy for hormone receptor-positive early breast cancer and as a first-line treatment for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. In addition, it treats advanced breast cancer in postmenopausal women who have not responded to treatment with tamoxifen. Anastrozole is a selective aromatase inhibitor. It is available under the brand name Arimidex.

Anastrozole Structure and Mechanism of Action

The chemical name of Anastrozole is α¹α¹α³α³-Tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1,3-benzenediacetonitrile. Its chemical formula is C₁₇H₁₉N_5, and its molecular weight is approximately 293.4 g/mol.

Anastrozole inhibits aromatase, which is an enzyme involved in the production of estrogen. By blocking this enzyme, Anastrozole can effectively reduce serum estradiol concentrations. It inhibits tumor growth and delays disease progression.

Anastrozole Impurities and Synthesis

During the synthesis¹ of Anastrozole, impurities form that can affect the quality and safety of the final product. It is essential to synthesize and analyze these impurities to ensure the quality and safety of the medicine. The impurities form due to various reasons, such as degradation of the API, reaction with the solvent, or contaminants in the starting materials. Their identification and characterization are crucial to assess their potential toxicity and ensure that they are present within acceptable limits.

Daicel Pharma provides a Certificate of Analysis (CoA) for Anastrozole impurity standards, including Alpha-Desmethyl Anastrozole, Anastrozole Diacid, and Anastrozole Dimer Impurity. The CoA is generated from a cGMP-compliant analytical facility and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We can also give additional characterization data like 13C-DEPT and CHN on request. Daicel Pharma is capable of preparing unknown Anastrozole impurities or degradation products. Each delivery has a complete characterization report.