Letrozole Powder CAS 112809-51-5

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Letrozole powder, the core component of letrozole, the chemical name is 1-[bis (4-cyanophenyl) methyl]-1,2,4-triazole, white or almost white crystalline powder, which is easily soluble in water to form tropicamide solution. It is a non steroidal estrogen synthase inhibitor, appearing as a white crystalline solid. The molecular formula is C17H11N5, and the corresponding molecular weight is 285.3 g/mol. There is no clear pH value in the pure state because it is not soluble in water. In pharmaceutical formulations, pH may be affected by other components. It is a combustible substance that may burn under open flames, producing carbon dioxide, water, and organic gases. It is a new generation of aromatase inhibitors and a synthetic derivative of benzotriazole. Letrozole inhibits aromatase and reduces estrogen levels, thereby eliminating the stimulating effect of estrogen on tumour growth and applying endocrine therapy to breast cancer.

Melting point 181-183 ° C , boiling point 563.5 ± 60.0 °C ( Predicted ) , Density 1.21 ± 0.1 g / cm3 ( Predicted ) , Storage conditions 2-8 ° C , Solubility of DMSO : > 50mg / mL , Acidity coefficient ( pKa ) 1.52 ± 0.11 ( Predicted ) , White powder in shape , Color white to off-white , Dangerous goods sign Xi , Hazard category code 36 / 37 / 38 , Safety instructions 26-36 , WGK Germany 3 , RTECS DI4957000 , InChIKeyHPJKCIUCZWXJDR-UHFFFAOYSA-N.

Letrozole powder, also known as 1 [bis (4-cyanophenyl) methyl] -1,2,4-triazole, is an artificially synthesized derivative of triphenyltriazole and belongs to the class of nonsteroidal aromatase inhibitors. It was developed by Swiss company Ciba and first launched in the UK in 1996 and in the US in 1997, and has been certified by the US Food and Drug Administration (FDA). Letrozole inhibits the activity of aromatase, blocks the conversion of androstenedione and testosterone to estrogen, thereby affecting the biosynthesis of estrogen and reducing estrogen levels in the body.

1. Antitumor effect

 

Letrozole is widely used in the field of anti-tumor, especially in the treatment of breast cancer. Breast cancer is one of the most common malignant tumors in women. endocrine therapy is an important part of comprehensive treatment for breast cancer. As an aromatase inhibitor, letrozole reduces estrogen levels by inhibiting aromatase, thereby eliminating the stimulating effect of estrogen on tumor growth. Research has shown that two-thirds of breast tumors in postmenopausal women are estrogen receptor positive, and letrozole has a significant therapeutic effect on these estrogen receptor positive tumors. Therefore, letrozole is widely used in endocrine therapy of breast cancer, especially in postmenopausal women.

 

In addition to breast cancer, letrozole is also used for the treatment of other estrogen dependent diseases, such as endometriosis, hysteromyoma, endometrial cancer and ovarian tumors. The occurrence and development of these diseases are closely related to estrogen levels, and letrozole can inhibit the progression of these diseases by reducing estrogen levels.

2. Ovulation induction effect

 

Letrozole also has important applications in the field of assisted reproduction. It can relieve the negative feedback regulation of estrogen on the hypothalamic pituitary gonadal axis and promote ovarian ovulation. For ovulation disorders such as polycystic ovary syndrome (PCOS), letrozole can be used as a first-line medication for ovulation induction. Research has shown that letrozole can significantly improve ovulation in PCOS patients, increase clinical pregnancy rates and live birth rates. In addition, letrozole can promote the formation of male sperm and has a certain therapeutic effect on male infertility.

1. Treatment of breast cancer

 

The application of letrozole in the treatment of breast cancer has been widely recognized. A study on postmenopausal women with breast cancer showed that letrozole significantly prolonged the progression free survival (PFS) and overall survival (OS) of patients compared with placebo. In addition, letrozole can reduce the risk of tumor recurrence and metastasis, and improve the quality of life of patients.

In practice, letrozole is usually used as a first-line endocrine therapy drug for postmenopausal women with estrogen receptor positive breast cancer patients. For patients after neoadjuvant chemotherapy, letrozole can also be used as an adjuvant therapy drug to reduce the risk of recurrence and metastasis.

2. Treatment of endometriosis

 

Letrozole powder is a common gynecological disease that is closely related to estrogen levels. Letrozole can inhibit the growth and proliferation of ectopic endometrium by reducing estrogen levels, thereby alleviating symptoms in patients. A study on patients with endometriosis showed that letrozole can significantly alleviate their pain and discomfort, and improve their quality of life.

In practical applications, letrozole is commonly used as a long-term therapeutic drug for patients with endometriosis to control disease progression and alleviate symptoms. For patients with severe symptoms, letrozole can also be combined with surgery to improve treatment effectiveness.

3. Treatment of uterine fibroids

 

Uterine fibroids are a common benign tumor, and their occurrence is closely related to estrogen levels. Letrozole can inhibit the growth and proliferation of fibroids by reducing estrogen levels. A study on patients with uterine fibroids showed that letrozole can significantly reduce the volume of fibroids and alleviate patients' symptoms.

In practical applications, letrozole is usually used as a conservative treatment for patients with uterine fibroids, especially for those with mild symptoms or those who are unwilling to undergo surgical treatment. Long term use of letrozole can control the growth of fibroids, alleviate symptoms, and improve patients' quality of life.

4. Ovulation induction therapy

 

The application of letrozole in ovulation induction therapy has been widely recognized. Especially for patients with ovulation disorders such as PCOS, letrozole can be used as the preferred ovulation inducing drug. A study on PCOS patients showed that compared to clomiphene, letrozole has advantages in improving ovulation, increasing clinical pregnancy rates, and live birth rates.

In practical applications, letrozole is commonly used as first-line ovulation induction therapy for PCOS patients. By monitoring follicle development and ovulation, adjusting the dosage and regimen of letrozole to achieve the best ovulation induction effect. For male infertility patients, letrozole can also promote sperm formation and improve semen parameters.

 

5. Other applications

In addition to the aforementioned applications, letrozole is also used for the treatment of other estrogen dependent diseases, such as ovarian tumors and male breast development. In addition, letrozole can also be used for the treatment of patients with bone metastases from breast cancer. By reducing the estrogen level, letrozole can inhibit the growth and proliferation of bone metastases.

Letrozole powder, with the chemical name Letrozole and the CAS number 112809-51-5, is an important non-steroidal aromatase inhibitor. It is mainly used for the treatment of hormone-dependent breast cancer. The manufacturing process of letrozole powder involves multiple intricate chemical steps. The following is a detailed description of the manufacturing information of letrozole powder.

I. Raw Material Preparation

 

The production of letrozole begins with the preparation of high-quality raw materials. The main raw materials include 4-cyanobenzophenone, sodium borohydride, methanol, dichloromethane, methanesulfonic acid, N,N-dimethylformamide (DMF), triazole, potassium carbonate, etc. These raw materials must undergo strict quality inspections to ensure their purity and quality meet the manufacturing requirements.

 

II. Synthesis Steps

4.4'-Dicyanodiphenylmethanol synthesis

In an alcohol solvent (such as methanol), 4-cyanobenzoic acid ketone is reduced by sodium borohydride at a temperature below 20°C to form 4,4'-dicyanodiphenylmethanol. This step requires strict control of the reaction temperature and time to ensure the purity and yield of the product.

4.4'-Dicyanodiphenylchloromethane synthesis

In a non-polar solvent (such as dichloromethane), 4,4'-dicyanodiphenylmethanol undergoes a chlorination reaction to form 4,4'-dicyanodiphenylchloromethane. In this step, methanesulfonic acid acts as a catalyst, and DMF is used as the solvent. The ratio of reactants and reaction conditions need to be precisely controlled.

Letrozole crude product synthesis

In a mixed solvent (such as DMF and toluene), 4,4'-dicyanodiphenylchloromethane reacts with triazole in the presence of potassium carbonate at around 80°C to form letrozole crude product. This step is the key in the entire synthesis process and requires strict control of the reaction temperature and time to improve the purity and yield of the product.

 

III. Refining and Purification

 

The letrozole crude product needs to undergo refining and purification steps to remove impurities and improve the purity of the product. Usually, the method of recrystallization is adopted. The letrozole crude product is dissolved in methanol, activated carbon is added for decolorization, then filtered, concentrated, cooled and crystallized to obtain high-purity letrozole powder. In this step, parameters such as the amount of solvent, decolorization time, crystallization temperature, etc. need to be precisely controlled to ensure the quality of the product.

 

IV. Drying and Packaging

 

The refined letrozole powder needs to undergo drying treatment to remove residual moisture and solvents. Vacuum drying or freeze-drying methods are commonly used to ensure the dryness and stability of the product. After drying, the letrozole powder needs to be strictly packaged to prevent moisture absorption and contamination. The packaging materials must comply with relevant standards to ensure the safety and efficacy of the product.

 

V. Quality Control

 

During the manufacturing process of letrozole powder, quality control is of utmost importance. Strict quality inspections must be conducted on raw materials, intermediates, and finished products, covering indicators such as purity, content, and impurity limits. Advanced analytical techniques such as high-performance liquid chromatography and ultraviolet-visible spectrophotometry are employed to ensure that the product quality complies with relevant standards and requirements.

1. What are the main research applications of Letrozole Powder?
In biomedical research, it is often used as an aromatase inhibitor to explore the related hormone regulation pathways and mechanisms of action.
2. How should this product be properly stored?
To maintain stability and activity, it is recommended to seal it, keep it away from light, and store it in a cool, dry place, such as in a freezer or refrigerator.
3. What should be noted when using this product?
This product is for laboratory research purposes only. During operation, strict adherence to laboratory safety protocols is required. It should be handled in a fume hood and appropriate personal protective equipment should be worn.
4. How should the waste from this product be handled?
As a chemical substance, its waste should be regarded as laboratory waste liquid or waste materials, and it needs to be classified and professionally handled in accordance with the safety guidelines of the laboratory and local environmental protection regulations.

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