In the pharmaceutical industry, sourcing ingredients like Copper Sulphate requires more than just high purity—it demands documentation, traceability, and regulatory compliance. One of the most important documents in this process is the Certificate of Analysis (COA).
At Chemignition Laboratory, we provide fully documented, GMP-compliant Copper Sulphate IP/BP/USP Grade with a complete set of certifications—trusted by pharma manufacturers and exporters worldwide.
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What Is a COA and Why Is It Important?
A Certificate of Analysis (COA) is a legally binding document issued by the manufacturer that provides actual test results of the batch being supplied. It ensures:
- Batch conformity to pharmacopeial standards (IP, BP, USP)
- Transparency in purity, assay, heavy metal content, and microbiological profile
- Confidence in formulation safety and consistency
Without a COA, most pharmaceutical companies cannot pass audits or release products.
Parameters Reported in Chemignition’s COA for Copper Sulphate
| Parameter | Test Method | Specification |
|---|---|---|
| Assay (CuSO₄·5H₂O) | Titrimetric | 99.0 – 102.0% |
| Appearance | Visual | Blue crystalline powder |
| Solubility | Qualitative | Soluble in water |
| pH (5% solution) | pH Meter | 3.0 – 4.5 |
| Chloride (Cl) | Limit Test | NMT 0.01% |
| Iron (Fe) | Limit Test | NMT 0.001% |
| Heavy Metals | Limit Test | NMT 10 ppm |
| Arsenic (As) | Limit Test | NMT 1 ppm |
| Loss on Drying | Gravimetric | 36.0 – 40.0% |
| Identification (Cu, SO₄) | Colorimetric/TLC | Passes tests |
| Microbial Limits | Plate Count Method | As per IP/BP/USP |
Additional Regulatory Certifications Provided by Chemignition
Along with the COA, Chemignition provides the following certifications for every batch:
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- GMP Certificate
- ISO 9001:2015 Certificate
- Certificate of Origin (COO)
- Free Sale Certificate (FSC)
- Non-GMO/BSE/TSE/Allergen-Free Declaration
- Heavy Metals & Elemental Impurity Report
- Microbial & Residual Solvent Testing Reports
Why Certifications Matter in Pharma Supply Chain
In regulated markets like the US, EU, and GMP zones, documentation is mandatory for:
- Regulatory filings (ANDA, DMF)
- Audit readiness
- Export/import clearance
- Traceability and product recall safety
Chemignition’s documentation ensures smooth operations, quick registration, and faster product development for our clients.
Countries We Export to with Documentation Support
Chemignition supplies Copper Sulphate IP/BP/USP Grade to over 30 countries, including:
- COA
- GMP
- ISO 9001:2015
- FSSC
- MSDS
- TDS
Documentation Pack Supplied with Each Order
| Document Name | Purpose |
|---|---|
| Certificate of Analysis (COA) | Confirms batch specs and test results |
| MSDS | Safe handling and hazard info |
| TDS | Technical product details |
| GMP Certificate | Proves regulatory compliance |
| ISO 9001:2015 | Assures consistent quality management |
| Certificate of Origin (COO) | Required for export and customs clearance |
| Free Sale Certificate (FSC) | Needed for OTC/pharma registration abroad |
| Test Reports (3rd Party) | Optional for high-regulatory markets |
Why Choose Chemignition for Copper Sulphate?
- In-house QA/QC lab for real-time testing
- Regulatory documentation pack with every batch
- 100% traceability & compliance
- Flexible MOQ for pharma clients
- Global shipping with export labels
Request COA or Documentation Sample Today
Ready to source COA-certified Copper Sulphate from a trusted manufacturer?
📨 Email: info@chemignition.com
🌐 Website: www.chemignition.com
📄 Request COA, MSDS, and regulatory docs now.
FAQs
What is included in Chemignition’s Copper Sulphate COA?
It includes assay, appearance, heavy metals, chloride, arsenic, loss on drying, identification, pH, and microbial tests.
Are your Copper Sulphate batches GMP certified?
Yes. All pharma-grade batches are GMP and ISO 9001:2015 certified.
Do you support custom COA formats?
Yes. For certain clients, we can include additional parameters upon request.
How quickly can I receive the documentation?
COA and MSDS are provided with every shipment. Regulatory docs are sent post-order confirmation or sample approval.
