When it comes to sourcing Sildenafil Citrate API for pharmaceutical formulation, quality assurance and regulatory compliance are non-negotiable. One of the most critical documents buyers and regulators demand is the Certificate of Analysis (COA) — a scientific report validating the product’s identity, purity, and consistency based on stringent testing.
In this blog, we’ll explain what a COA is, why it matters, and how Chemignition Laboratory, a leading manufacturer and exporter of Sildenafil Citrate API, ensures regulatory and quality compliance with every batch produced.
📄 What is a COA (Certificate of Analysis)?
The API manufacturer issues a Certificate of Analysis to confirm that the product meets its predefined specifications. This document includes detailed test results for:
- Identity
- Purity
- Impurity profile
- Loss on drying
- Residue on ignition
- Assay
- Enantiomeric purity
- Physical description and solubility
✅ COA Specification of Sildenafil Citrate API by Chemignition Laboratory
Explore a leading manufacturer of APIs.
With over 10 years of expertise, we ensure GMP compliance and provide reliable, high-quality solutions.
Chemignition Laboratory reports the following official specification parameters in the COA of its Sildenafil Citrate API:
| Test | Specification |
|---|---|
| Description | White or almost white crystalline powder |
| Solubility | Freely soluble in dimethyl sulfoxide, slightly soluble in methanol, practically insoluble in water |
| Identification by IR | Spectrum matches that of Sildenafil Citrate reference standard |
| Identification by HPLC | Retention time matches with the reference standard solution |
| Organic Impurities by HPLC (%w/w) | Individual: NMT 0.1% Total: NMT 0.5% |
| Enantiomeric Purity (% HPLC) | R-enantiomer: NMT 0.1% |
| Loss on Drying (at 105°C for 3 hrs) | NMT 1.0% |
| Residue on Ignition (%w/w) | NMT 0.1% |
| Assay by HPLC (on dried basis) | Not less than 98.0% and not more than 102.0% |
NMT = Not More Than
🏆 Chemignition’s Regulatory Certifications
Chemignition Laboratory upholds the highest quality and regulatory standards to serve global pharmaceutical clients.All Sildenafil Citrate API batches are:
- GMP Certified
- Accompanied by COA, MSDS, MOA, and Stability Data
- Produced under strict quality systems aligned with ICH Q7 guidelines
- Compliant with Indian and international pharmacopeia standards
🌍 Why It Matters for Global Buyers
Pharma buyers — especially in regulated markets like the US, EU, and the Middle East — must verify that APIs are manufactured in compliance with regulatory standards. A valid COA and regulatory documentation ensure:
- Product quality and consistency
- Risk mitigation during audits
- Faster drug approval processes
- Global trade and import clearance
🔍 Why Choose Chemignition Laboratory?
As a trusted Sildenafil Citrate API manufacturer, supplier, and exporter, Chemignition Laboratory is known for:
- Advanced in-house analytical labs
- Batch-wise documentation with real-time traceability
- Worldwide supply network
- Custom packing solutions
- Strong cold-chain and logistics controls
Final Thoughts
A COA is not just paperwork — it’s proof of pharmaceutical integrity. When sourcing Sildenafil Citrate API, make sure you’re getting more than just a product. Choose a supplier like Chemignition Laboratory, who backs every shipment with scientific transparency, regulatory trust, and consistent quality.
Looking to import Sildenafil Citrate API with complete documentation?
Get in touch with Chemignition Laboratory today — your trusted global partner in Active Pharmaceutical Ingredients.
Contact Chemignition Laboratory for GMP-certified Sildenafil Citrate API today.
- Get high-purity API
- CoA, MSDS, Stability data, Impurity profile available
- Global shipping & regulatory support
Contact Us for bulk quotes, samples, or technical data sheets.
FAQs
What is a Certificate of Analysis (COA)?
A Certificate of Analysis (COA) is an official document provided by the manufacturer that confirms the API meets all specified quality parameters, such as purity, appearance, identification, residual solvents, and assay.
Why is a COA important for Sildenafil Citrate API buyers?
The COA verifies that the API complies with pharmacopeial and regulatory standards. It helps buyers ensure consistency, quality, and safety in their formulations and is often required for regulatory submissions.
What information does Chemignition Laboratory include in the Sildenafil Citrate COA?
Chemignition Laboratory includes test results for:
Appearance
Identification (IR & UV)
Solubility
Water content (by KF)
Residual solvents
Related substances
Assay (API potency)
Heavy metals
pH
Melting point
Microbial limits (if applicable)
What regulatory documents are available with Chemignition’s Sildenafil Citrate API?
We provide the following:
Certificate of Analysis (COA)
Material Safety Data Sheet (MSDS)
Certificate of Origin
Stability data
GMP certificate
Is Chemignition’s Sildenafil Citrate API compliant with international pharmacopeias?
Yes, our API complies with major pharmacopeias such as USP, EP, IP, and meets international regulatory requirements.
