In the formulation of modern ophthalmic drugs—especially those targeting glaucoma and ocular hypertension—the choice of Active Pharmaceutical Ingredient (API) can determine not only the effectiveness of the drug, but also its stability, safety, and market approval. Among these, Tafluprost API for ophthalmic use has emerged as a preferred compound due to its proven efficacy, high purity standards, and compatibility with preservative-free eye drop formulations.
Among the key ingredients used in glaucoma treatment is Tafluprost, a prostaglandin F2α analog that has become an essential molecule in the development of high-performance, preservative-free eye drops.
This blog explores the grades, quality parameters, and purity specifications of Tafluprost API used in ophthalmic formulations, with insights into how Chemignition Laboratory ensures world-class manufacturing for regulated markets.
What is Tafluprost API?
Tafluprost is a synthetic prostaglandin analog that mimics the function of naturally occurring prostaglandin F2α. It works by increasing the uveoscleral outflow of aqueous humor, thereby lowering intraocular pressure (IOP) in patients with:
- Open-angle glaucoma
- Ocular hypertension
- Post-operative IOP elevation
Tafluprost is typically used in 0.0015% ophthalmic solutions, often formulated without preservatives to improve tolerability.
In its API form, Tafluprost must meet strict standards to be suitable for human eye administration.
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Why API Purity and Grade Matter in Ophthalmic Use
Ophthalmic APIs like Tafluprost are applied directly to the eye—one of the most sensitive areas of the body. As a result, regulators and formulators demand extremely high levels of quality, with strict controls on:
- Sterility
- Particulate matter
- pH and solubility
- Impurity profiles
- Stability under storage conditions
Even a minor deviation in API purity or solvent content can cause irritation, vision problems, or drug instability.
API Grades for Tafluprost – IP, BP, USP, and EP
At Chemignition Laboratory, Tafluprost API is manufactured in multiple pharmacopoeial grades to support global clients:
| Grade | Standard Followed | Market Use |
|---|---|---|
| IP | Indian Pharmacopoeia | Domestic (India) |
| BP | British Pharmacopoeia | UK, Commonwealth countries |
| USP | United States Pharmacopeia | USA, Canada |
| EP | European Pharmacopoeia | EU countries |
Each grade is developed with matching analytical methods, impurity profiles, and residual solvent limits to ensure compliance with local health authorities.
Manufacturing Conditions for Ophthalmic APIs
Ophthalmic-grade Tafluprost must be produced in a GMP-compliant cleanroom with:
- Controlled air handling units (AHU)
- HEPA filtration systems
- Temperature and humidity monitoring
- Validated equipment for mixing and drying
- Strict operator hygiene protocols
Chemignition’s facilities follow ICH Q7 guidelines for API production, ensuring complete traceability and batch control.
Key Quality Attributes of Tafluprost API
The quality of Tafluprost API is assessed through a combination of physicochemical tests and analytical methods such as HPLC, GC, and UV. Key parameters include:
| Attribute | Specification |
|---|---|
| Assay (Purity) | ≥ 99.0% by HPLC |
| Related Substances | ≤ 0.5% total impurities |
| Residual Solvents | NMT 500 ppm (as per ICH Q3C) |
| Water Content | ≤ 0.5% |
| Heavy Metals | Within ICH Q3D limits |
| Specific Optical Rotation | Confirmatory test |
| Appearance | White to off-white crystalline powder |
| Particle Size | Customizable for formulation requirements |
Chemignition provides batch-specific COAs for every shipment and retains samples for internal audit and client verification.
Importance of Sterility and Microbial Testing
While Tafluprost API itself is not sterile, its microbial load must be extremely low, and it must be suitable for sterilization during the final drug product formulation.
We perform:
- Total viable aerobic count (TVAC)
- Bacterial endotoxin testing (BET)
- Pathogen screening (E. coli, Salmonella, S. aureus)
This ensures compatibility with aseptic filling and sterilization processes in ophthalmic drug manufacturing.
Packaging to Protect API Integrity
Tafluprost is sensitive to light, heat, and moisture, which can degrade the molecule and alter its efficacy. Chemignition uses a 3-layer packaging system:
- Primary: Type I amber glass or polypropylene vials
- Secondary: High-density polyethylene (HDPE) polybags
- Tertiary: Triple-laminated aluminum pouches + HDPE container
All packages are labeled with:
- Product name and code
- Batch number and MFG/EXP date
- Storage instructions (–20°C to –10°C)
- Pharmacopoeial grade (IP/BP/USP/EP)
Stability Data & Shelf Life
Chemignition conducts accelerated and long-term stability studies under ICH guidelines:
- Accelerated: 40°C / 75% RH (6 months)
- Long-Term: –20°C ±5°C (up to 36 months)
Tafluprost API typically offers a shelf life of 24–36 months, provided it is stored and handled under recommended cold-chain conditions.
Documentation for Regulatory Submissions
All Tafluprost APIs from Chemignition come with complete regulatory documentation required for ophthalmic formulations, including:
- COA (Certificate of Analysis)
- MSDS (Material Safety Data Sheet)
- Elemental impurity & residual solvent profile
- Batch manufacturing record (BMR)
- Stability data
- Analytical method validation (on request)
Supporting Global Ophthalmic Brands
Chemignition currently supplies Tafluprost API to formulation companies in the US, UK, Germany, Brazil, and Southeast Asia. Our global clients trust us for:
- Batch-to-batch consistency
- Compliance with country-specific regulations
- Fast response for COA, samples, or documentation
- On-time delivery with cold-chain logistics
Why Choose Chemignition for Ophthalmic Tafluprost API?
| Feature | Benefit |
|---|---|
| GMP-certified manufacturing | Assures safety, quality, and regulatory compliance |
| Global-grade availability | IP, BP, EP, USP support for every market |
| Regulatory document readiness | Speeds up drug filing and registration |
| Cold-chain packaging | Ensures molecule stability in transit |
| Scalable supply chain | Suitable for R&D and commercial manufacturing |
Conclusion: Start Your Ophthalmic Formulation with Confidence
When it comes to ophthalmic-grade Tafluprost API, you cannot compromise on purity, safety, or documentation. Chemignition Laboratory ensures that every batch you receive meets global benchmarks and helps you accelerate product development with confidence.
Whether you’re in early-stage R&D or commercial manufacturing, we are your trusted API partner.
📞 Contact Us for Tafluprost API Samples & Quotes
- Website: www.chemignition.com
- Export: Worldwide
FAQs
What is Tafluprost API used for in ophthalmic formulations?
Tafluprost API is used to manufacture ophthalmic solutions (eye drops) that help reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
What grades of Tafluprost API are available for eye formulations?
Chemignition Laboratory offers Tafluprost API in IP, BP, USP, and EP grades.
Why is API purity important in ophthalmic drugs?
Ophthalmic drugs are applied directly to the eye, making them highly sensitive. Tafluprost API must have high purity, low microbial load, and a tight impurity profile to ensure safety, stability, and efficacy.
Is Tafluprost API manufactured under GMP conditions?
Yes. Chemignition Laboratory manufactures Tafluprost API in a GMP-certified facility with strict environmental controls, validated equipment, and full batch traceability.
What are the recommended storage conditions for Tafluprost API?
Tafluprost API should be stored at –20°C to –10°C in a tightly sealed, light-resistant container to maintain its stability and effectiveness.
Do you provide stability data and documentation with the API?
Yes. We provide a complete documentation package including COA, MSDS, impurity profile, stability data, and batch manufacturing records.
