High-Quality Sildenafil Citrate Raw Material Supply (CAS 171599-83-0)

High-Quality Sildenafil Citrate Raw Material Supply (CAS 171599-83-0)

Sildenafil Citrate is an active pharmaceutical ingredient (API) for male sexual function. The common dosage form is tablets, with sildenafil citrate as the core ingredient. Its core mechanism of action is to inhibit the breakdown of cyclic guanosine monophosphate (cGMP) by phosphodiesterase type 5 (PDE5) inhibitors, raising tissue cGMP levels, thereby relaxing smooth muscle and increasing local blood flow.

Product Introduction

Sildenafil Citrate is an active pharmaceutical ingredient (API) for male sexual function. The common dosage form is tablets, with sildenafil citrate as the core ingredient. Its core mechanism of action is to inhibit the breakdown of cyclic guanosine monophosphate (cGMP) by phosphodiesterase type 5 (PDE5) inhibitors, raising tissue cGMP levels, thereby relaxing smooth muscle and increasing local blood flow. It is the world's first approved oral drug for the treatment of male erectile dysfunction.

Effects and Efficacy: The core indication is male erectile dysfunction, which requires sexual stimulation to take effect, taking effect within 30 minutes to 1 hour after administration for most patients. It can also be used to treat pulmonary arterial hypertension by dilating pulmonary arterial blood vessels to reduce pressure and improve patient exercise tolerance. Additionally, it can be used for the prevention of high-altitude illness in people with a history of acute mountain sickness when entering areas above 3,000 meters in altitude.

Usage and Dosage: For most patients, the recommended dose is 50 mg, taken as needed approximately 1 hour before sexual activity; however, it may be taken anytime from 0.5 to 4 hours before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg (maximum recommended dose) or decreased to 25 mg. The maximum recommended dosing frequency is once per day. Sildenafil has no effect in the absence of sexual stimulation.

 

Product Description and Parameters

 

Our company specializes in Sildenafil Citrate API raw material, providing a stable supply for domestic and foreign pharmaceutical enterprises, R&D institutions, and foreign trade customers for the long term. The product adopts mature synthesis technology, with high purity and strictly controlled impurity indicators. Each batch is accompanied by a complete COA quality inspection report, satisfying pharmacopoeia standards and formulation production requirements. As a first-hand source supplier, our company eliminates intermediate links, offering sufficient supply, distinct price advantages, and high cost-performance ratios, and is capable of accepting lab-scale R&D samples as well as bulk orders. The product is suitable for multiple fields, including erectile dysfunction formulation production, pulmonary arterial hypertension drug R&D, and pharmaceutical scientific research reference standards. Regarding packaging, we support 25kg standard fiber drums as well as customized sub-packaging specifications, featuring moisture-proof sealing. Logistics can cover domestic dedicated lines as well as foreign trade sea freight and air freight, with complete export documentation provided. The company is equipped with a professional technical team to provide product-related technical consultation, following up on order progress throughout the after-sales process to properly handle various supply issues, dedicated to establishing long-term stable cooperative relationships with our vast client base.

 

Name Sildenafil Citrate (International Generic Name)
Chemical Name 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H,5H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate
Appearance White or off-white crystalline powder, slightly hygroscopic
Assay 99%
Chemical Formula C28H38N6O11S
Molecular Weight 666.7
CAS No. 171599-83-0
EINECS No. 200-659-6
Melting Point 187-189℃
Boiling Point 672.4℃
Flash Point 360.5℃
Density 1.445 g/cm3
Refractive Index 1.683
pH (Aqueous Solution) 3.0~4.5 (20mg/20ml water)
Solubility Slightly soluble in water; slightly soluble in methanol; extremely slightly soluble in ethanol; almost insoluble in n-hexane; easily soluble in DMSO
Water Content ≤2.5% (Karl Fischer method)
Residue on Ignition ≤0.1%
Related Substances Single impurity ≤0.1%, Impurity ≤0.15%, total impurities strictly controlled, HPLC testing
Residual Solvents Complies with pharmacopoeia limit requirements
Storage Conditions Protect from light, keep sealed, store in a cool and dry place, moisture-proof and light-proof
Regular Packaging 25 kg/fiber drum, inner double-layer PE sealed bag with built-in desiccant; sample in aluminum foil vacuum bag
product-800-800
product-800-800

 

What is the Main Effect of Sildenafil Citrate?

 

1.Belongs to the selective phosphodiesterase type 5 (PDE5) inhibitors, mainly used for formulations related to male erectile dysfunction.
2.Under the premise of sexual stimulation, it inhibits the PDE5 enzyme, reduces cGMP breakdown, and relaxes penile corpus cavernosum smooth muscle.
3.Dilates corpus cavernosum blood vessels, increases local blood perfusion, and helps obtain and maintain an effective erection.

 

Product Application Fields

 

product-800-800

1.Production of pharmaceutical solid preparations, used for Sildenafil Citrate tablet preparation to treat male erectile dysfunction.
2.Pulmonary arterial hypertension drug R&D, developing related formulations to improve exercise tolerance in patients with pulmonary arterial hypertension.
3.Pharmaceutical pharmacological research, serving as experimental raw materials for in vitro and in vivo pharmacological activity trials.
4.Pharmaceutical quality testing, used as reference standards for assay and related substance testing analysis.
5.API import and export business, supplying raw material procurement needs for domestic and overseas pharmaceutical enterprises.
6.R&D of innovative dosage forms, used for formulation development of new oral dosage forms such as orally disintegrating tablets and dispersible tablets.
7.Toxicology trials, supporting scientific research projects related to drug safety evaluation.
8.Scientific research projects in medical colleges, available for laboratory teaching and research projects in universities.
9.Development of pharmaceutical analytical methods, establishing raw material and formulation testing standards and inspection schemes.
10.Generic drug development projects, used for generic drug formulation screening and process optimization trials.
11.Stability study research, investigating the long-term and accelerated stability of raw materials and formulations.
12.Pharmaceutical third-party testing institutions, used for standard sample calibration and proficiency testing experiments.

 

Product Purity

 

1.This product is Sildenafil Citrate API raw material, main content ≥99.0%, tested by High-Performance Liquid Chromatography (HPLC), with stable and compliant indicators.
2.Single impurities and total impurities are strictly controlled within low limits, meeting quality standards for pharmaceutical raw materials.
3.Each factory batch is accompanied by a COA quality inspection report; content, impurities, and other purity-related data can be verified, with minimal batch-to-batch variation.

 

Product Testing Methods

 

1.Identification: Infrared Spectroscopy (IR), comparing test sample infrared spectra with reference spectra; HPLC retention time comparison identification; citrate chemical color reaction.
2.Assay Determination: High-Performance Liquid Chromatography (HPLC) external standard method to determine the main component content of sildenafil citrate.
3.Related Substances: High-Performance Liquid Chromatography (HPLC) to detect individual impurities and total impurities, controlling impurity limits.
4.Water Content Determination: Karl Fischer volumetric method to test sample water content.
5.Residue on Ignition: Gravimetric method, weighing after high-temperature ignition to determine residue percentage.
6.Heavy Metals: Atomic absorption spectrophotometry to determine heavy metal element content.
7.Residual Solvents: Gas Chromatography (GC) to detect residual amounts of various organic solvents.

 

Packaging and Logistics

 

1.Regular bulk goods adopt 25kg fiber drum packaging, inner layer double-layer PE sealed bag, built-in desiccant for moisture prevention.
2.Samples use aluminum foil vacuum bags sealed to isolate air and water vapor, ensuring stable raw material storage.
3.Customized sub-packaging specifications can be provided according to customer needs, with product name, batch number, and indicators marked on the outer packaging.
4.Packaging is reinforced with buffer protection before leaving the warehouse to prevent transport compression and damage.
5.Domestic orders adopt room-temperature dedicated line freight transport, with full-process protection against rain, sun exposure, and moisture.
6.Foreign trade orders support sea freight and air freight, equipped with complete customs declaration documents to assist overseas customs clearance.
7.Orders are rapidly scheduled for shipment after confirmation, with logistics transport dynamics available for real-time query and tracking.
8.Product information is carefully verified before shipment to ensure accurate specifications and quantities of goods.

 

After-Sales Service

 

Our company is equipped with a comprehensive after-sales service system. Products undergo strict inspection before leaving the warehouse, attached with a COA quality inspection report. After receiving the goods, if customers have questions regarding product quality or packaging, they may contact us at any time, and we will quickly respond and check batch testing data. Technical consultation related to raw materials can be provided to answer formulation and testing questions. In case of abnormal situations such as transport damage, we negotiate and properly handle them in a timely manner after customers provide relevant proof. Orders are followed up throughout the process, synchronizing delivery dates and logistics information. We value customer demands, operate with integrity, safeguard customer procurement rights, and establish long-term stable cooperative relationships.

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