When sourcing pharmaceutical-grade Travoprost API, verifying Travoprost API COA (Certificate of Analysis) and regulatory certifications is essential for ensuring quality, safety, and compliance. Whether you’re formulating for the Indian, European, British, or U.S. market, each region demands specific regulatory documentation to meet strict pharmaceutical standards.
In this blog, we break down what a Travoprost API COA includes, explain major international pharmacopoeial certifications like IP, BP, EP, and USP, and show how Chemignition Laboratory ensures you receive compliant and trustworthy API.
What is a Certificate of Analysis (COA)?
A Certificate of Analysis (COA) is an official quality assurance document issued by the API manufacturer. It outlines:
- Product identity (Travoprost, CAS number)
- Batch number and manufacturing date
- Pharmacopoeial grade (IP, BP, EP, USP)
- Purity level and assay results
- Impurities and residual solvents
- pH, appearance, melting point
- Storage conditions
- Retest or expiry date
A COA verifies that the API batch complies with all required specifications and meets the standards of the corresponding pharmacopoeia.
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Below is a real reference of Travoprost API COA from Chemignition Laboratory:
| Sr. No. | Test | Specification |
|---|---|---|
| 01 | Description | Pale yellow to yellow color oil |
| 02 | Solubility | Freely soluble in methanol |
| 03 | Identification | A) By IR: Should match Travoprost reference standardB) By HPLC: Retention time should match |
| 04 | Water Content | Not more than 1.0% |
| 05 | Specific Optical Rotation | +52° to +58° |
| 06 | Related Substances by HPLC | A) Compound A ≤ 0.20%B) Epoxide ≤ 0.40%C) 15-epi ≤ 0.10%D) 5,6 Trans ≤ 3.00%E) 15-keto ≤ 0.30%F) Other individual impurity ≤ 0.10%G) Total impurity ≤ 4.0% |
| 07 | Assay by HPLC | Not less than 96.0% w/w and not more than 102.0% w/w |
| 08 | Residual Solvents by GC | DCM ≤ 600 ppm, Toluene ≤ 890 ppm, Ethyl acetate, THF, Methanol, Ethanol, Acetone ≤ 5000 ppm |
Note: Additional tests may be conducted based on customer-specific requirements.
Travoprost API Pharmacopoeial Grades Explained
Travoprost is classified under various pharmacopeias to ensure global usability. Chemignition Laboratory manufactures and supplies all major grades:
✅ Travoprost IP Grade
Used for pharmaceuticals formulated and sold in India, compliant with the Indian Pharmacopoeia (IP) standards.
✅ Travoprost BP Grade
Meets requirements of the British Pharmacopoeia, ensuring compatibility for UK and Commonwealth markets.
✅ Travoprost EP Grade
Approved under the European Pharmacopoeia, this grade is essential for EU market entry and EMA approvals.
✅ Travoprost USP Grade
Certified to meet U.S. Pharmacopeia (USP) standards, required for drugs submitted to the FDA in the United States.
Each grade is tested for its own set of limits on impurities, identification methods, and assay specifications.
Key Regulatory Certifications for Travoprost API
1. GMP Certification
Confirms the API is produced in a facility that adheres to Good Manufacturing Practices, ensuring product quality and batch consistency.
2. US DMF (Drug Master File)
Required for FDA submissions, a US DMF includes detailed information about the manufacturing process, quality control, and facilities.
3. CEP (Certificate of Suitability)
Issued by the European Directorate for the Quality of Medicines (EDQM), a CEP allows easy API registration in European countries.
4. COFEPRIS, ANVISA, and Other National Certifications
Depending on the target market, additional certifications may be required in Mexico, Brazil, or other regulated regions.
Importance of Travoprost API Documentation
✅ Facilitates Market Entry
Pharmacopoeial certification and regulatory documents are essential for obtaining marketing authorization.
✅ Ensures Product Quality & Compliance
Regulatory-compliant APIs reduce the risk of recalls, audit failures, or rejection by health authorities.
✅ Smooth Customs & Export Clearance
Proper documentation ensures a hassle-free import/export process, especially for temperature-sensitive APIs.
What Buyers Should Ask From Their Supplier
Before placing an order, always request:
- Certificate of Analysis (COA)
- GMP Certificate
- Stability Data
- Pharmacopoeial grade confirmation (IP/BP/EP/USP)
- BSE/TSE Certification
- Regulatory filing status (US DMF, CEP)
These documents validate both quality and compliance.
Why Choose Chemignition Laboratory?
Chemignition Laboratory is a trusted GMP-certified manufacturer and exporter of Travoprost API, offering all pharmacopoeial grades:
- Travoprost IP Grade
- Travoprost BP Grade
- Travoprost EP Grade
- Travoprost USP Grade
We ensure:
- 100% batch-specific COA
- Global regulatory documentation (GMP certificate)
- Cold-chain shipping and validated packaging
- Dedicated support for audits and registrations
Want to receive a regulatory-compliant COA or full documentation set?
Website: www.chemignition.com
Final Thoughts
Sourcing Travoprost API without verified COAs or regulatory certifications is a risky practice. Whether you’re targeting the Indian, U.S., European, or global markets, having the correct pharmacopoeia grade and documents is vital for your success.
With Chemignition Laboratory, you don’t just buy API—you buy peace of mind, global compliance, and guaranteed quality.
FAQs
What is a Travoprost API COA?
A Travoprost API COA (Certificate of Analysis) is an official document issued by the manufacturer that confirms the API’s quality, identity, purity, and compliance with specific pharmacopoeial standards (IP, BP, EP, or USP). It includes test results for assay, impurities, residual solvents, water content, and more.
Why is a COA important when sourcing Travoprost API?
A COA ensures that the Travoprost API batch you are receiving meets the required quality standards and regulatory specifications, reducing the risk of formulation issues, regulatory rejection, or product recalls.
Which pharmacopoeial grades are available for Travoprost API?
Chemignition Laboratory provides Travoprost API in IP, BP, EP, and USP grades, suitable for pharmaceutical applications in India, the UK, Europe, and the United States respectively.
What should a complete documentation set include for Travoprost API?
A compliant documentation pack should include:
Certificate of Analysis (COA)
GMP Certificate
Stability data
BSE/TSE Certificate
Regulatory status (DMF/CEP)
Safety Data Sheet (SDS/MSDS)
How can I verify the COA is authentic?
Always ask for batch-specific COAs with matching batch numbers, manufacturing date, and manufacturer’s signatory stamp. You may also cross-verify the COA with the supplier or request a third-party lab verification.
