Sildenafil Powder Bulk

1.Name:Sildenafil
2.Appearance:White powder
3.Specification:98%
4.CAS No.:139755-83-2
5.Molecular Formula:C22H30N6O4S
6.Molecular Weight:474.58
7.Certificates: FDA,Organic,Kosher, ISO, HALAL, FSSC, cGMP
8.Factory situation:Factories & Three production lines.cGMP standard workshop & two independent laboratories.
9.Storage method:Dry and cool place
10.Export Only

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Product Description

Bulk Sildenafil Powder | Pharmaceutical API Raw Material USP Standard | Hongda Phytochemistry

Sildenafil powder bulk is a high-demand active pharmaceutical ingredient for licensed pharmaceutical manufacturing and regulated laboratory research. Our sildenafil API Powder is produced following cGMP workflow, manufactured to meet USP specification, with strict control over related substances, heavy metals and residual solvents. Every production batch undergoes full panel analytical testing before release. We maintain stable bulk inventory and export-grade light-shielded, moisture-proof packaging for intercontinental shipments.

Critical Disclaimer: Our product is pharmaceutical API raw material only. Sales limited to licensed pharmaceutical manufacturers and qualified research labs. Not for dietary supplement, food, cosmetic or direct consumer use. Buyers must hold valid local import & manufacturing licenses and take full responsibility for compliance with regional pharmaceutical regulations.

If you are qualifying API suppliers for pharma manufacturing or lab research, send your inquiry with your license information, target formulation and destination market to get full technical files:

duke@hongdaherb.com

What is Sildenafil?

Sildenafil citrate powder (bulk) (CAS: 139755-83-2) is a potent and selective PDE5 inhibitor that is primarily used to treat erectile dysfunction and pulmonary arterial hypertension. Sildenafil citrate powder is a safe, fast-acting, and highly effective API that inhibits cGMP-specific phosphodiesterase type 5 (PDE5) activity, allowing nitric oxide (NO) to function more effectively. PDE5 is an enzyme that degrades cGMP. cGMP is a molecule that relaxes muscles and increases blood flow to them. Sildenafil citrate powder increases cGMP levels, which improves blood flow to body tissues by widening blood vessels.

✅ Greater than 99.5% pure PDE5 inhibitory active site, maximizing peak plasma concentration per milligram administered in tablets or jelly.

✅ Rigorous impurity control for regulatory audits

Related substances and residual solvents are heavily reviewed during pharmaceutical registration and factory audits. We provide full impurity profile per batch, which reduces your documentation workload for regulatory submission.

✅ Stable crystal property for tablet manufacturing

Irregular crystal shapes often cause poor compression and tablet capping issues during production. Our consistent crystal form helps your formulation team maintain stable tablet yield and reduce trial waste.

✅ Dedicated technical support for API formulation teams

Our technical team offers practical guidance for powder storage, material handling and compatibility notes for excipient compounding. We can also adjust particle parameters to match your production equipment requirements.

Sildenafil powder bulk----Shaanxi hongda phytochemistry

Product Specification

NO.	TEST	SPECIFICATION	RESULT
1.	Description	White or almost white slightly hygroscopic crystalline powder.	Conform
2.	Solubility	Slightly soluble in water and in methanol, practically insoluble in hexane.	Complies
3.	Identification by IR	The Infrared absorption spectrum of sample is concordant with the spectrum of Sildenafil citrate RS	Complies
4.	Water content by （KF）	Not more than 2.5 % w/w ≤2.5% w/w	1.49 % w/w
5.	Residue on ignition	Not more than 0.1% w/w ≤1.0% w/w	0.04 % w/w
Organic impurities by HPLC
6.	Sildenafil related compound A	Not more than 0.3 % ≤0.30 %	BDL
	Any other unspecified individual impurity	Not more than 0.10 % ≤0.10 %	BDL
	Total unspecified impurities	Not more than 0.3 % ≤0.30 %	BDL
	Total impurities	Not more than 0.5 % ≤0.30 %	BDL
7.	Assay by HPLC (On anhydrous and solvent free basis)	Not less than 98.0% w/w to not more than 102.0 % w/w 98.0%~102.0% w/w	99.00 % w/w

Note: Lot-specific COA and HPLC chromatogram will be supplied with each shipment. Additional analytical records can be provided for your supplier qualification audit upon formal request.

Production & QC Workflow Targeted For API Consistency

Many API quality deviations come from incomplete purification, uncontrolled crystallization and poor moisture barrier packaging. Our workflow is built to stabilize crystal form and keep impurity levels within tight limits:

Raw material qualification & incoming audit: All synthesis starting materials go through identity, impurity and heavy metal testing. Non-conforming raw materials are rejected before entering production.
Controlled crystallization process: Temperature and pH are tightly managed during crystallization to maintain consistent crystal morphology, which directly affects powder flow and compression performance during tablet pressing.
Multi-step purification & recrystallization: Multiple rounds of recrystallization remove reaction by-products and residual organic solvents, to satisfy strict ICH impurity limits required for pharma registration.
Low-temperature drying & particle sifting: Controlled drying prevents crystal transformation. Sieving and particle homogenization optimise powder flowability for tableting operations.
Full panel batch release testing: Each finished batch runs HPLC assay, impurity profiling, residual solvent, heavy metal and microbial testing before release. No batch ships without full QC sign-off.
Light & moisture sealed packaging:Sildenafil API is packed immediately after QC approval. Double light-blocking aluminum foil bags avoid degradation caused by light and humidity during long sea freight.

Submit your inquiry for full API technical documentation: duke@hongdaherb.com

Uses for Sildenafil API Powder:

✅ Treatment for Erectile Dysfunction: Sildenafil powder bulk is the main active ingredient in erectile dysfunction medications. It aids men in achieving and maintaining an erection by boosting blood flow to the penile tissues.

✅ Treating Pulmonary Arterial Hypertension (PAH): Lowers blood pressure in the lungs, making exercise easier for patients with PAH.

✅ R&D: Conducts drug research and develops new formulations.

Why Should You Pick Shaanxi Hongda?
✅ R&D Technical Support:

Hongda Phytochemistry runs a full cGMP-compliant API production and analytical laboratory. Our lab is equipped with HPLC, melting point analyzers and related-substance testing instruments, enabling in-house full batch testing and generating original analytical records for customer supplier audits. Every production stage retains complete batch manufacturing records.

Laboratory

✅Packaging, Storage & Shipping Guidance

‑ Standard packing: 1kg vacuum-sealed aluminum foil bag; 25kg light-shield fiber drum with double aluminum inner bag. Custom packing options negotiable.

‑ Storage instruction: Keep drums tightly sealed in cool, dry and dark warehouse. Avoid light exposure, high humidity and repeated opening. Once opened, consume quickly.

‑ Shipping: Air freight or sea freight available. Light-blocking moisture-proof packaging is standard. Extra protective packing can be arranged for tropical high-humidity routes.

‑ Lead time: In-stock orders 10–16 working days after deposit confirmation; custom crystal specification batches require extended production cycle.

packaging

✅Industry Experience:

We are long-term exhibitor at global ingredient and pharmaceutical raw material events including CPHI Worldwide and Vitafoods Europe. At these exhibitions, we hold face-to-face discussions with pharma procurement teams, R&D chemists and raw material distributors across many regions. We continuously refine our API quality standards, packaging solutions and documentation service according to real regulatory and formulation feedback collected at these expos. Our long-term global industry exposure helps us understand international API audit standards and cross-border pharmaceutical shipping requirements.

Exhibitions

FAQs:

1. How pure is the sildenafil powder?

USP 795 testing confirms pharmaceutical-grade purity of at least 98%.

2. Are there any additives or fillers?

Sildenafil crystal powder is completely natural and contains no chemicals, sweeteners, or preservatives.

3. What is the particle size of the powder, as well as its appropriateness for formulation?

Particles are ≤10µm and can be dissolved in water, ethanol, or oil. They are suitable for capsules, tablets, functional beverages, microencapsulation, and pharmaceutical applications.

4. Minimum Order Quantity:

1kg minimum bulk order. Customer-specific 25kg moisture-proof paper drums or 300g-5kg compact packages are available.

5. How to obtain samples for formulation verification?

A 100g free sample is provided, but this requires a stable supply of large orders in the future. A complete test report will be attached to the sample.

6. What if the received batch does not meet quality requirements?

After a complaint, our technical customer service will verify within 48 hours. Upon confirmation, we can provide a replacement of the same batch or a full refund, and issue a quality analysis report.

7. Is this raw material compliant in Europe and America?
Sildenafil bulk powder meets US FDA and EU EMA PDE5 inhibitor raw material safety and quality standards with FDA GRAS notification and EU Novel Food clearance. Functional foods, health products, pharmaceutical R&D, and clinical studies can use it directly.