Products
Latanoprost API
Latanoprost API is the Active Pharmaceutical Ingredient (bulk drug substance) used to manufacture latanoprost eye drops for glaucoma and ocular hypertension. It is not a public “data API” (like a web service), but the pharmaceutical raw material supplied to formulators.
Get Top-Quality Latanoprost Pharmaceutical Ingredient in India
Product Specifications
| Latanoprost API Technical Details | |
|---|---|
| Product Name | Latanoprost (Isopropyl (Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]hept-5-enoate) |
| Category | Active Pharmaceutical Ingredient (API) – Prostaglandin F2α Analog |
| Chemical Name | Latanoprost (Prostaglandin F2α isopropyl ester) |
| CAS Number | 130209‑82‑4 |
| Molecular Formula | C₂₆H₄₀O₅ |
| Molecular Weight | 432.59 g/mol |
| Pharmacopoeia Compliance | USP / EP / In‑house specifications |
| Therapeutic/Application | Ophthalmic – Reduction of elevated intraocular pressure in open-angle glaucoma and ocular hypertension |
| Form | Light yellow viscous oil / solution (API) |
| Assay (HPLC) | 98.0–102.0% (typical in‑house specification) |
| Related Substances | Individual impurity ≤ 0.10%; Total impurities ≤ 0.50% (by validated RP‑HPLC) |
| Residual Solvents | Compliant with ICH Q3C limits (e.g., methanol, ethanol, ethyl acetate as applicable) |
| Water Content | ≤ 0.50% (Karl Fischer) |
| Microbiological Quality | TAMC ≤ 10² CFU/g; TYMC ≤ 10¹ CFU/g; Absence of E. coli, S. aureus, P. aeruginosa, Salmonella spp. |
| Packaging | Type I glass or PP vial → poly bag → triple-laminated aluminum pouch → HDPE drum (light-resistant, air-tight) |
| Shelf Life | Up to 36 months (under recommended storage, validated stability) |
| Storage Conditions | Store at −20°C to −10°C in tightly closed, light-resistant containers; validated short-term transport at 2–8°C |
| Certifications / Compliance | Manufactured in WHO‑GMP facility; CoA, MSDS, impurity profile, stability data; DMF/ASMF/CEP available on request |
In ophthalmic care, the difference between progressive vision loss and long-term visual stability often comes down to one molecule. Latanoprost is that molecule for millions of patients worldwide, serving as the gold-standard prostaglandin F2α analog for lowering intraocular pressure. For manufacturers, it represents a high-value, low-dose API (typically 0.005% w/v in eye drops) where purity, stereochemistry, and stability directly impact clinical performance.
As a premier API manufacturer in India, SNA Healthcare is focused on providing you the essential starting materials for advanced ophthalmic formulations. We operate as one of the leading Latanoprost API suppliers in India who understands that formulators depend on this active ingredient for their most critical glaucoma and ocular hypertension products. Our Latanoprost API is synthesized and controlled to tight specifications for identity, potency, related substances, and residual solvents, ensuring consistent performance in finished eye-drop formulations.
Latanoprost API Role in Advanced Ophthalmic Formulations
Proven Mechanism for Intraocular Pressure Control
Latanoprost is a selective FP receptor agonist that increases uveoscleral outflow of aqueous humor, effectively reducing elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. Its well-documented efficacy and once-daily dosing make it a first-line therapy in modern glaucoma management.
High-Potency, Low-Dose API with Stringent Quality Needs
With a typical finished-product strength of 0.005% (50 mcg/mL), Latanoprost API is used at microgram levels, making purity and consistency critical for batch-to-batch performance and patient safety. Our in‑house specifications target 98.0–102.0% assay by HPLC, with tight control over individual and total related substances to support stable, clear ophthalmic solutions.
Robust Stability and Cold-Chain Handling
Latanoprost is light- and temperature-sensitive; our packaging and storage protocols (−20°C to −10°C in light-resistant containers, validated 2–8°C transport) protect API integrity from manufacture to formulation. This minimizes degradation pathways (e.g., hydrolysis to latanoprost acid) and supports shelf life up to 36 months under validated conditions.
Regulatory-Ready Documentation for Global Markets
For regulated markets, we support customers with comprehensive documentation including CoA, MSDS, detailed impurity profiles, method validation summaries, and stability data, along with DMF/ASMF/CEP as required. This accelerates your regulatory filings for US, EU, and other key markets while maintaining compliance with ICH guidelines on impurities and residual solvents.
Secure Your Latanoprost API Supply Today!
You can see the value of a high-quality API like Latanoprost in the final ophthalmic product. As a foundational Latanoprost pharmaceutical ingredient India trusts, its purity, stereochemical integrity, and stability are the first and most important steps in any glaucoma formulation. SNA Healthcare provides a product that you can rely on for your most critical manufacturing processes, backed by rigorous QC and regulatory support. Contact us if you need to buy Latanoprost API in India for domestic or export formulations.
