High Purity Sildenafil Citrate Powder API Supplier | GMP Pharmaceutical Grade
In today's highly competitive pharmaceutical market, sourcing a reliable, high-purity API supplier is critical to ensuring product quality, regulatory compliance, and long-term business success. Our High Purity Sildenafil Citrate Powder is manufactured under strict GMP conditions using advanced synthesis and purification technologies, delivering consistent ≥99% purity, excellent stability, and full compliance with international standards (USP/EP).
As a trusted global supplier, we support pharmaceutical manufacturers, distributors, and R&D institutions with stable bulk supply, complete technical documentation, and flexible customization options. Whether you are developing generic drugs or scaling up production, our sildenafil citrate API ensures quality you can trust and performance you can rely on.
Technical Specifications
|
Parameter |
Specification |
|
Product Name |
Sildenafil Citrate |
|
CAS Number |
171599-83-0 |
|
Molecular Formula |
C28H38N6O11S |
|
Molecular Weight |
666.7 g/mol |
|
Appearance |
White or off-white crystalline powder |
|
Purity (HPLC) |
≥ 99.0% |
|
Loss on Drying |
≤ 0.5% |
|
Residue on Ignition |
≤ 0.1% |
|
Heavy Metals |
≤ 10 ppm |
|
Residual Solvents |
Complies with ICH Q3C |
|
Particle Size |
Customized upon request |
|
Shelf Life |
24 months |
|
Storage |
Store in a cool, dry, well-ventilated area |
Key Advantages of Our Sildenafil Citrate API
Competitive advantage
High Purity & Low Impurity Profile
Our product undergoes multi-step purification and recrystallization processes to ensure exceptional purity (≥99%) and strict impurity control, meeting international pharmaceutical standards.
01
GMP-Compliant Manufacturing
Produced in a GMP-certified facility, ensuring batch-to-batch consistency and suitability for regulated markets.
02
Complete Documentation Support
We provide comprehensive technical documents, including:
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
Stability Data
DMF support (upon request)
03
Strong Supply Capability
Sample quantities available (10g–100g)
Pilot-scale production
Bulk supply for long-term contracts
04
Global Export Experience
We have successfully supplied to:
North America
Europe
Southeast Asia
Middle East
05
Quality Control System
Quality is at the core of our production process. Our sildenafil citrate powder is tested through a rigorous multi-stage quality control system:
Raw material inspection and supplier qualification
In-process quality monitoring
Final product testing using HPLC, GC, and IR analysis
Third-party testing support (SGS, Intertek)
Each batch is accompanied by a detailed COA to ensure traceability and compliance.
Manufacturing Process Overview
Our production process is designed to ensure high yield, purity, and consistency:
Process Flow:
Raw Materials → Chemical Synthesis → Intermediate Purification → Crystallization → Drying → Milling → Quality Testing → Packaging
Process Highlights:
Advanced synthesis technology for high yield
Controlled crystallization for optimal particle size
Strict impurity removal process
Fully traceable production system
Regulatory & Compliance Support
We understand the importance of regulatory compliance in pharmaceutical production. Our sildenafil citrate API supports:
USP / EP standards compliance
GMP manufacturing documentation
DMF filing assistance (if required)
Regulatory consultation support
