Sildenafil Raw Material 139755-83-2

Introduction to Sildenafil Production and Parameters

Our company specializes in the production of sildenafil raw materials, strictly following the pharmaceutical production management system, with mature and stable processes, high product purity, and controllable impurity indicators. COA quality inspection report and third-party testing can be provided as needed The complete set of technical documents such as MSDS safety instructions can be coordinated with customers to connect relevant filing materials and support large and small batch orders. The factory has a complete quality control system, with layer by layer testing from raw material feeding to finished product outbound. The product is a white crystalline powder with standardized packaging, which can meet the logistics needs of foreign trade exports. Only for procurement from legitimate pharmaceutical research institutions, both buyers and sellers must comply with relevant national and export laws and regulations, and do not supply to non compliant channels.

1. Conventional adult dose (for male erectile dysfunction)
The recommended starting dose is 50mg, taken approximately 0.5-1 hour before sexual activity; It can also be taken at any time between 30 minutes and 4 hours before sexual activity.
According to the efficacy and tolerability, the dose can be adjusted to a maximum of 100mg (maximum recommended dose) or reduced to 25mg. It can be taken up to once every 24 hours and cannot be repeated.
2. Special populations
Elderly people (over 65 years old): It is recommended to start with 25mg and adjust according to the effect;
For patients with liver and kidney dysfunction: initial recommendation is 25mg;
Simultaneously taking some antihypertensive drugs and alpha blockers requires a reduction in dosage and must be evaluated by a doctor.
3. Main function; Male functional impairment. And those who endure pain for a long time.

The content of sildenafil raw materials is usually required to be ≥ 98.5%, with a drying weight loss of no more than 0.5%. The individual impurities of related substances should be controlled within 0.5%, and the total impurities should be ≤ 1.0%. The appearance should be a white crystalline powder. The mainstream detection method uses high-performance liquid chromatography (HPLC), with a C18 reverse phase chromatography column and a mobile phase composed of acetonitrile phosphate buffer system in proportion. The detection wavelength is set at 290nm, the column temperature is controlled at 30 ℃, and the flow rate is set at 1.0mL/min. The test sample is dissolved in a mobile phase to a certain volume and prepared into a suitable concentration test solution. The control sample is prepared using the same method and injected separately for measurement. The sample content is calculated based on peak area using the external standard method, and relevant substance inspections are also completed. The detection process is synchronized with trait identification, physical and chemical constant determination, and qualitative confirmation is carried out by comparing infrared spectroscopy (IR) with standard spectra. Provide COA testing reports for each batch, fully recording the content, impurities, and physical and chemical testing data. This detection method has strong specificity and good reproducibility, and can effectively distinguish between principal components and degraded impurities. It is suitable for raw material storage inspection and finished product release testing.