High Content Tadalafil Raw Material 171596-29-5

Tadalafil picture and basic information

Tadalafil is a raw material sold by our company for treating male erectile dysfunction. It appears as a white or off white crystalline powder with a uniform color and no lumps. The product has undergone multiple refining and purification processes, with a purity of over 99%. The single and total impurity indicators are strictly controlled, and solvent residues and heavy metals meet the standards for medicinal raw materials.

Tadalafil raw materials started with laboratory small-scale research and development in the early stages, repeatedly optimizing reaction conditions, overcoming the problem of selective synthesis of chiral intermediates, and solving the industry pain points of difficult isomer separation and low yield. After multiple rounds of process iteration, the complete transformation from small-scale and pilot scale to large-scale production has been completed. Core processes such as condensation, acylation, and cyclization have been continuously optimized, and recrystallization refining technology has been improved to effectively reduce process impurities and solvent residues. Establish a standardized quality control system throughout the production process, and perform HPLC testing on every intermediate step to continuously improve product purity and batch stability. After undergoing process polishing, stable mass production has been achieved, which can meet the needs of large and small batch orders. It is equipped with complete testing, packaging, and foreign trade shipping processes, providing stable quality Tadalafil raw materials for compliant pharmaceutical research customers at home and abroad.

Tadalafil raw material is calculated as a dry product, with a main ingredient content controlled between 98.0% and 102.0%. The actual purity of our product can reach over 99%. Strictly control relevant substances, with a maximum single impurity not exceeding 0.5% and a total impurity limit of ≤ 1.0%, with a focus on controlling chiral isomers, process by-products, and degradation impurities. Dry weight loss ≤ 0.5%, ignition residue ≤ 0.1%, heavy metal and organic solvent residues meet the ICH general standards. HPLC and high-performance liquid chromatography were used for content and impurity detection, and infrared spectroscopy was used for qualitative confirmation. COA reports were issued for each batch, and complete detection data was retained. The fluctuation of indicators between batches was small, meeting the quality control standards for pharmaceutical research and development raw materials.

Tadalafil raw materials are mainly used in the field of pharmaceutical research and development, with a core focus on the development of drugs for male erectile dysfunction, and can also be used in the research of drugs for the treatment of benign prostatic hyperplasia. With its long-lasting pharmacological properties, it is commonly used in scientific formula experiments for tablets and other dosage forms, and can be used by pharmaceutical companies and research institutions for prescription screening, process research, and sample development. Our company's raw material has high purity and controllable impurities, which can meet the raw material requirements for laboratory research and development, small-scale formulation testing, and large-scale formulation feeding.

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