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Pure Sildenafil Powder
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
- Product Description
Pharmaceutical-Grade Pure Sildenafil Powder | cGMP-Compliant API for ED Medication Manufacturing
Pure sildenafil powder is one of the most important pharmaceutical raw materials in modern medicine, widely used as the active ingredient in various drugs. Hongda Phytochemicals is a leading company in the pharmaceutical raw material market. We have earned a reputation for high-quality pure sildenafil by strictly controlling every step of the production process to ensure product quality. To ensure that every batch of pure sildenafil meets international pharmaceutical standards, we use the latest processes and testing equipment.
The sildenafil citrate powder supplied by Shaanxi Hongda uses the core "multi-level gradient recrystallization" technology to ensure that the product presents a perfect white crystalline state, with total impurities strictly controlled below 0.1% and specific single impurities less than 0.05%. As an active ingredient in leading global andrology drugs, our pure sildenafil is produced in a modern factory that meets cGMP, ISO22000, and FSSC22000 standards. Furthermore, our stable supply chain, comprehensive documentation, and rapid technical support will help your products achieve high value and high standards.
Core Features
When you choose Pure Sildenafil from Shaanxi Hongda, you get:
- 99.5% HPLC-Verified Purity: Rigorously tested for contaminants (residual solvents <0.1ppm) to meet pharmacopeial standards.
- Customizable Particle Sizes: Optimize dissolution rates with 20-200µm particles for tablets, capsules, or sublingual strips.
- Batch-to-Batch Consistency: Advanced purification processes and third-party SGS testing ensure uniform quality.
Extreme Monitoring of Genotoxic Impurities: We implement internal control standards that are even more stringent than USP43 and EP10. Using LC-MS/MS coupled technology, we ensure that potentially genotoxic impurities and residual solvents (such as ethanol, methanol, and ethyl acetate) are kept below extremely low detection limits.
100% Independent Synthesis Chain: Our production line is completely independent of other highly sensitive chemicals and meets the latest 2026 GMP Class D cleanroom standards. Each batch undergoes three high-precision molecular sieve filtrations to ensure that it is absolutely free of any undeclared analogues or illegally added residues.
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 | |||
What are the main benefits of pure sildenafil powder?
Sildenafil powder is a PDE5 inhibitor that keeps cGMP from breaking down, which increases blood flow to the penis. This makes it easier to get and keep an erection while you're excited.
How to Handle Pulmonary Arterial Hypertension (PAH)
It is used on both adults and children with PAH because it makes the blood vessels in the lungs softer, which makes the heart's job easier.
Formulation Flexibility
The powder form makes it easy to measure out the right amount and is great for mixing to generate tablets, capsules, or other delivery methods. This gives researchers and manufacturers cheap options.
Cardiovascular and Cognitive Benefits (Emerging Evidence)
Recent, large-scale studies show that men with ED who take sildenafil may have a lower risk of dying from any cause, having a heart attack or stroke, or even getting dementia.
Support for Vascular Health
Sildenafil may enhance endothelial cell function and reduce inflammation, potentially benefiting conditions such as vein graft intimal hyperplasia.
Application Scenarios
- Formulating generic or branded ED tablets, chewables, and sublingual strips.
- Blending with excipients for direct compression, encapsulation, or spray‑drying.
- Developing fixed‑dose combinations where precise potency is critical.
Our technical team can advise on excipient compatibility, dissolution profiles, and stability testing to accelerate your product development.
Compliance & Certifications
We offer Pure Sildenafil Powder that has been certified by cGMP, ISO22000, FSSC22000, FDA, Halal/Kosher (upon request), and organic compliance when needed. There is a Certificate of Analysis, an MSDS file, a DMF file, and GMP audit records for every batch. These have all been checked by third-party labs like SGS and Eurofins. This paperwork makes it easier to send legal documents to markets in the US, EU, Middle East, and Asia-Pacific.
Why Choose Shaanxi Hongda?
Manufacturing Excellence
- 10+ Production Lines: 100,000-class purification workshops ensure pharmaceutical-grade output.
- Scalable Capacity: Annual production of 3,000+ tons with rapid lead times.
Quality Assurance
- In-House SGS Lab: HPLC/GC testing for identity, assay, and stability.
- Traceability: Raw materials sourced from controlled planting bases.
R&D Support
- 20+ Experts: Patent-backed synthesis technologies for enhanced efficacy.
Global Logistics
- 3,000㎡ Warehouse: Sterilized storage zones and DDP/DAP shipping options.
Ordering & Logistics
- MOQ: 1kg (sample), bulk orders from 100kg.
- Delivery: Samples in 3-5 days, bulk orders in 7-15 days.
- Packaging: Tamper-evident HDPE drums compliant with international standards.
FAQ
Q: Can you assist with EU/US regulatory submissions?
A: Yes, we provide DMF files and dossier preparation support.
Q: What’s the lead time for 500kg?
A: 10-12 days post-confirmation, with real-time tracking.
Q: What certifications support market entry?
A: FDA, Halal, Kosher, ISO 9001/22000, and regional approvals (EMA, WHO‑PQ, ANVISA) are available on request.
Q: How is raw‑material traceability ensured?
A: Each batch is linked to controlled planting bases and documented through our ERP system, providing full traceability from raw material to final product.
Q: Can urgent bulk orders be fulfilled within 5 days?
A: Our dedicated production lines and stocked inventory enable rapid turn‑around for critical shipments.
Q: Do you provide technical support for formulation optimization?
A: Yes. Our R&D scientists assist with pre‑clinical testing, stability studies, and regulatory dossier preparation.
Call to Action
Ready to accelerate your ED product line? Request a sample of Pure Sildenafil Powder and receive the latest COA within 48 hours.
For detailed inquiries, custom formulations, or technical assistance, email us at duke@hongdaherb.com or connect with our technical team via WhatsApp.
