Sildenafil Citrate Powder - High-Purity Pharmaceutical Grade API for Advanced Healthcare Manufacturing

Xi'an Le-Nutra Ingredients Inc is a professional Pharmaceutical Grade Sildenafil Citrate Powder manufacturer and supplier with min. purity 99.0% in China. Our chemical is CAS No. 171599-83-0 compliant and is a trusted active pharmaceutical ingredient (API) in erectile dysfunction therapies and pulmonary arterial hypertension products. We have over 14 years of experience in the synthesis of active substances and annual capacity of 3,000 tonnes in 6 multipurpose lines, providing constant batch quality that meets the USP, EP and BP pharmacopoeia criteria for pharmaceutical producers throughout the world.

Physicochemical Properties and Technical Specifications

Our material has ideal properties for pharmaceutical manufacturing. The off-white crystalline powder has good chemical stability under ICH storage conditions, with a molecular weight of 666.7 g/mol and a molecular formula of C22H30N6O4S·C6H8O7.

The chemical is a strong and selective inhibitor of cyclic guanosine monophosphate specific phosphodiesterase type 5 (PDE5). This process allows for effective design of therapies for vascular diseases that need better blood flow regulation.

Technical Parameter Table:

Parameter	Specification
Product Name	Sildenafil Citrate Powder
CAS Number	171599-83-0
Appearance	Off-white crystalline powder
Assay	≥99.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20ppm
Methyl Alcohol	≤0.3%
Ethyl Alcohol	≤0.5%
Dichloromethane	≤0.06%
Ethyl Acetate	≤0.5%
Total Impurities	≤0.5%
Loss on Drying	Controlled
Grade	Pharmaceutical Grade

Manufacturing Excellence and Quality Assurance

Our production method uses the latest extraction systems and rigorous quality control protocols. All batches are fully analytical tested for assay titration, heavy metals by ICPMS, chromatographic purity and microbiological profile.

We have professional laboratory facilities with sophisticated analytical instruments. Our QC team provides batch traceability services and supports third-party testing needs. All goods are GMP, ISO and FDA compliant and hence acceptable for regulatory approval in all markets worldwide.

Safety stock over 30 days enables uninterrupted supply chains. We prove operational reliability with a 98% on-time delivery rate for large purchases and special projects.

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Formulation Advantages for Pharmaceutical Development

The crystalline structure is optimised for the flowability and compressibility during the tablet pressing operations. You get highly defined particle properties which makes it easier to design solid oral dosage forms.

The substance we use addresses critical formulation obstacles such stability issues and bioavailability discrepancies that generic production faces. High purity in standardised form removes the hassle of synthesising stable PDE5 inhibitors by yourself.

Thermal processing is possible due to melting point between 188°C-202°C. Micronization techniques are used to increase dissolution rates in gastric fluids, due to the compound's poor solubility in aqueous media.

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Application Scope and Clinical Relevance

This Sildenafil Citrate Powder is a pharmaceutical ingredient which is applicable in several therapeutic areas. The primary uses are in drugs for erectile dysfunction, where inhibition of PDE5 results in increased blood flow to vascular tissues. Other uses include treating pulmonary arterial hypertension by relaxing blood vessels in the lungs and reducing strain on the heart.

Your formulations are characterised by fast onset and consistent therapeutic efficacy. The compound has a well-characterized safety profile and regulatory filings in international markets.

The available dosage forms of this API are oral tablets in the strengths of 25mg to 100mg and powder for oral suspension having a concentration of 10mg/mL.

Customization Services and OEM/ODM Support

We offer complete customisation services, including formula development, specification modification, and private label. Our R&D team will work with you to optimise the purity, adapt it to the dosage form and design the packaging according to your needs in the market.

500g-1kg sample orders are welcome for your research and development. Flexible MOQ options can be provided to meet large-scale production demand with the bulk manufacturing capabilities.

All shipments are supplied with full technical documentation: ISO certificates, COA, TDS, MSDS and MOA. We support compliance testing for food, pharmaceutical, and supplement regulations worldwide.

Global Supply Chain and Logistics Solutions

Our established raw material network includes certified organic farms and long-term logistics partnerships. We offer multiple delivery terms: EXW, FOB, CFR, CIF, DAP, and DDP to match your procurement preferences.

Products ship in 25kg fiber drums with double-layer food-grade polyethylene bag liners. Storage recommendations specify away-from-light conditions with 24-month shelf life under proper conditions.

Payment flexibility includes 100% T/T and Alibaba International Trade Assurance orders. Current inventory status shows in-stock availability for immediate fulfillment.

Packaging and Order Information

Standard packaging utilizes 25kg fiber drums with protective food-grade liners. Small-scale sample orders accommodate 500g-1kg quantities for research purposes.

Multiple delivery terms provide procurement flexibility. Complete documentation supports customs clearance and regulatory compliance verification.

FAQ

Q: What does the product do?

A: This chemical improves erectile dysfunction by increasing blood flow when aroused, making it simpler to maintain physiological responses. It also treats pulmonary arterial hypertension by relaxing blood arteries in the lungs and lowering blood pressure, which reduces the strain on the heart.

Q: Who shouldn't use this ingredient?

A: Formulations containing sildenafil API should not be used by anyone who have a known allergy to sildenafil or any of the components of the product. Those on nitrate medicines or other PDE-5 inhibitors should consult a physician before use. Recent cardiovascular incidents should be assessed by a health care physician to determine if physical activity is appropriate.

Q: How should products be stored?

A: Oral tablet formulations should be stored at room temperature, 68°F-77°F (20°C-25°C), in cool, dry places. Oral liquid solutions are stable at room temperature below 86°F (30°C) or refrigerated between 36°F-46°F (2°C-8°C) with a shelf life of 60 days following reconstitution.

Q: What quality control measures apply?

A: Analytical testing is quite strict. Assay titration shows 98.0%-102.0% purity. Heavy metals are screened with strict limitations (Lead <0.5ppm, Arsenic <0.5ppm). Loss on drying is less than 0.5%. Chromatographic purity assessment is performed, and microbiological testing is also done to ensure that there are no microorganisms.

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Partner with a Trusted API Supplier

Ready to discuss your pharmaceutical ingredient requirements with Sildenafil Citrate Powder? Contact our technical team at enquiry@lenutra.com for detailed specifications, sample requests, or customized solutions tailored to your formulation needs.