Introduction
When sourcing Tafluprost API, especially for regulated pharmaceutical markets, understanding and obtaining a Certificate of Analysis (COA) and other regulatory certifications is essential.
This guide explains what a COA is, what regulatory certifications matter for Tafluprost API, and how Chemignition Laboratory provides COA-verified and globally compliant APIs that meet the highest industry standards.
What is Tafluprost API?
Tafluprost is a prostaglandin analog used in ophthalmic drug formulations to treat open-angle glaucoma and ocular hypertension. Its effectiveness and safety rely on the quality, purity, and compliance of the active pharmaceutical ingredient (API).
Chemignition Laboratory manufactures Tafluprost API under IP, BP, EP, and USP grades, with a focus on quality consistency and regulatory readiness.
What is a COA (Certificate of Analysis)?
A Certificate of Analysis (COA) is an official document issued by the manufacturer confirming that a particular batch of the API meets pre-defined specifications. It’s a critical quality control and regulatory compliance document used globally.
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Tafluprost API COA – Chemignition Laboratory Reference
Below is the reference COA for Tafluprost API provided by Chemignition Laboratory, highlighting key quality parameters and specifications that are tested for every batch before release:
| Sr. No. | Test | Specification |
|---|---|---|
| 01 | Description | Light yellow viscous oil |
| 02 | Solubility | Freely soluble in ethanol |
| 03 | Identification | A) By HPLC: The retention time of the principal peak in the chromatogram of the sample preparation should match with that of the standard preparationB) By IR: Infrared absorption spectrum obtained from the sample should correspond to the Tafluprost reference standard spectrum. |
| 04 | Water Content | Not more than 0.5% |
| 05 | Specific Optical Rotation | +16° to +23° |
| 06 | Related Substances by HPLC | Purity: Not less than 99.0%Tafluprost related 5,6 trans: Not more than 0.15%Tafluprost related Acid: Not more than 0.15%Tafluprost related TPP: Not more than 0.15%Any other individual impurity: Not more than 0.10%Total impurity: Not more than 0.50% |
| 07 | Assay by HPLC (on anhydrous basis) | Not less than 98.0% w/w to not more than 102.0% w/w |
| 08 | Residual Solvents by GC | Dichloromethane: Not more than 600 ppmMethyl tert-butyl ether: Not more than 5000 ppmEthyl acetate: Not more than 5000 ppmTHF: Not more than 720 ppmMethanol: Not more than 3000 ppmEthanol: Not more than 5000 ppmAcetone: Not more than 5000 ppmAcetonitrile: Not more than 410 ppm |
Why a Valid COA is Crucial for Tafluprost API Buyers
✔ Confirms Batch Quality
The COA ensures consistency across batches, verifying purity, impurity levels, and other safety parameters.
✔ Required for Drug Filing
Whether you’re submitting to US FDA, EMA, CDSCO, or TGA, a COA is a mandatory part of your regulatory dossier.
✔ Builds Trust with CMOs & Distributors
Third-party partners rely heavily on COAs to verify product quality during audits or commercial evaluations.
Regulatory Certifications Provided by Chemignition
To complement the COA, Chemignition Laboratory provides a complete documentation package to ensure regulatory compliance:
- GMP Certificate – Validates our high-standard manufacturing process
- ISO 9001:2015 Certification – Proves strong quality management systems
- Stability Data, MSDS, TSE/BSE Statements, Allergen Declarations
Why Partner with Chemignition for Tafluprost API?
- Tafluprost API manufactured under strict GMP compliance
- Full regulatory documentation including COA, MSDS, and stability data.
- Global supply with export experience to over 20 countries
- Cold chain storage and packaging ensures product stability
- Long shelf life – up to 36 months under proper storage
How to Order Tafluprost API with COA & Certifications
Website: www.chemignition.com
Our commercial and regulatory teams will assist you with quotations, COA samples, documentation sets, and technical clarifications.
Conclusion
A properly documented COA and a complete set of regulatory certifications are critical when sourcing Tafluprost API for pharmaceutical applications. Chemignition Laboratory delivers pharmacopeia-grade Tafluprost with full documentation and strict quality controls, making us a trusted API supplier for ophthalmic formulations worldwide.
FAQs
What is a COA in pharmaceutical APIs like Tafluprost?
A Certificate of Analysis (COA) is an official quality document issued by the manufacturer that certifies a specific batch of Tafluprost API meets all predefined quality specifications including assay, impurities, solvents, and identification.
What parameters are tested in Tafluprost API COA?
hemignition’s COA includes parameters such as:
Assay (by HPLC)
Water content
Optical rotation
Impurity profiling
Residual solvents (by GC)
Identification (HPLC & IR)
Physical description & solubility
Why is a COA important when sourcing Tafluprost API?
A COA ensures:
The API meets pharmacopeial standards
Regulatory documentation is complete for product registration
Consistency in formulation and efficacy
Safety and compliance in international markets
Is the COA provided with every shipment of Tafluprost API?
Yes, Chemignition provides a batch-specific COA with every delivery of Tafluprost API, duly signed by the Quality Assurance team.
What regulatory certifications come with Tafluprost API from Chemignition?
Chemignition provides:
GMP Certificate
ISO 9001:2015
MSDS
Stability data
TSE/BSE-free declaration
Allergen-free and non-animal origin certification (if needed)
Can I request additional tests for Tafluprost API?
Yes. Additional tests such as elemental impurities, endotoxin levels, or specific microbial profiles can be conducted based on customer requirements.
What is the shelf life and storage condition of Tafluprost API?
Tafluprost API should be stored between -20°C to -10°C. Shelf life is typically up to 36 months under controlled storage conditions.
