Travoprost is a prostaglandin analogue widely used in ophthalmic formulations to reduce intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. Its efficacy in improving aqueous humor outflow makes it a critical component in eye drop formulations.
The main active ingredient in ophthalmic Travoprost formulations is Travoprost API, which is directly responsible for the effectiveness of the drug in reducing IOP. This API must meet the highest standards of quality, purity, and regulatory compliance to ensure safe and effective treatment outcomes.
Travoprost API is manufactured by Chemignition Laboratory with 100% quality assurance, backed by GMP certification, validated documentation, and full pharmacopoeial compliance.
In this blog, we break down everything pharmaceutical buyers and formulators need to know about using Travoprost for ophthalmic formulations, including grade classification, quality benchmarks, and the importance of COA and documentation.
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Why Travoprost is Ideal for Ophthalmic Use
Travoprost is preferred due to its:
- High efficacy in lowering IOP
- Minimal systemic absorption
- Once-daily dosage regimen
- Compatibility with other ocular APIs (e.g., Timolol)
Its lipophilic structure allows effective penetration through the cornea, making it ideal for ophthalmic formulations.
Grades of Travoprost API
Pharmaceutical companies must ensure that the API grade aligns with regional pharmacopoeial requirements. Chemignition Laboratory offers:
✅ Travoprost IP Grade
Complies with Indian Pharmacopoeia—suitable for India’s domestic market and regional exports.
✅ Travoprost BP Grade
Meets British Pharmacopoeia standards—accepted across the UK and Commonwealth countries.
✅ Travoprost EP Grade
Compliant with European Pharmacopoeia—a must for EU regulatory filings and EMA approvals.
✅ Travoprost USP Grade
Manufactured per U.S. Pharmacopeia standards—required for FDA-approved drugs in the United States.
Each grade has specific testing limits for assay, impurities, residual solvents, and optical rotation.
Quality Parameters for Ophthalmic Travoprost API
To ensure therapeutic effectiveness and patient safety, the following quality criteria must be met:
1. Purity Level
- Assay by HPLC: Not less than 96.0% w/w and not more than 102.0% w/w
- Total impurities: Not more than 4.0%
2. Water Content
- Not more than 1.0% to prevent degradation
3. Specific Optical Rotation
- Should fall between +52° to +58°, ensuring correct isomeric form
4. Residual Solvents
- Solvents like Methanol, THF, and DCM should be within pharmacopeial limits
5. Related Substances by HPLC
- Control of 5,6 Trans Isomer, 15-keto, Epoxide, and other impurities to pharmacopeial thresholds
These parameters are typically documented in the Certificate of Analysis (COA) provided by the API manufacturer.
Packaging & Storage for Stability
Due to its light-sensitive and thermally unstable nature, Travoprost API should be:
- Stored between -20°C to -10°C
- Packaged in glass or polypropylene vials, sealed in triple-laminated aluminum bags, and placed in HDPE containers
- Shipped using cold-chain logistics
Compliance & Documentation for Regulatory Approval
Formulators must ensure:
- GMP Certification from manufacturer
- COA and stability data
- Regulatory support (Stability data, Impurity detail)
- Pharmacopoeial grade compliance (IP/BP/EP/USP)
Chemignition Laboratory provides full documentation support to help manufacturers expedite regulatory submissions.
Why Source from Chemignition Laboratory?
Chemignition Laboratory is a trusted manufacturer and exporter of Travoprost API for ophthalmic formulations. We provide:
- All four pharmacopoeia grades (IP/BP/EP/USP)
- 100% compliant COAs with batch-specific data
- Strict impurity profiling and residual solvent testing
- Validated cold-chain packaging and delivery
- Custom documentation support for regulated markets
Whether you’re formulating for India, or other then India, we ensure quality and regulatory readiness.
Final Thoughts
Using Travoprost for ophthalmic formulations demands more than just sourcing the API—it requires trust in quality, documentation, and consistency. From grade selection to packaging and impurity profiling, every detail matters.
Choose a GMP-certified partner like Chemignition Laboratory to ensure your formulations are backed by the best Travoprost API available.
Need a COA or pricing for Travoprost API?
🌐 Website: www.chemignition.com
FAQs
What is Travoprost used for in ophthalmic formulations?
Travoprost is used in eye drop formulations to reduce intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. It enhances the outflow of aqueous humor from the eye, helping prevent optic nerve damage and vision loss.
Is Travoprost API the main active ingredient in eye drops?
Yes. The Travoprost API is the main active ingredient in ophthalmic solutions. It is directly responsible for the therapeutic effect of reducing eye pressure in glaucoma treatments.
Which pharmacopoeia grades are available for Travoprost API?
Travoprost API is available in IP, BP, EP, and USP grades, depending on the regulatory requirements of different regions. Chemignition Laboratory manufactures and supplies all these grades to meet global compliance standards.
Why choose Chemignition Laboratory for sourcing Travoprost API?
Chemignition Laboratory is a GMP-certified manufacturer of Travoprost API offering:\n- All major grades (IP/BP/EP/USP)\n- Batch-specific COAs\n- Full documentation for regulatory filings\n- Strict quality control and impurity profiling\n- 100% cold-chain validated packaging
What documents are required when purchasing Travoprost API for ophthalmic use?
You should always request:\n- Certificate of Analysis (COA)\n- GMP Certificate\n- Stability data\n- Pharmacopoeia compliance confirmation\n- Regulatory support documents.
