CAS · 1025967-78-5
Product Overview
lifitegrast is a high-purity a-api supplied for industrial and specialty chemical applications. Contact our team for specifications, packaging options and lead times.
Product Specifications
| Appearance | White or off-white powder |
|---|---|
| Solubility | Easily soluble in N,N-dimethylformamide; slightly soluble in methanol and acetonitrile; almost insoluble in water |
| Identification (IR) | Consistent with the spectrum of the reference substance |
| Identification (HPLC) | Retention time of the main peak of the test solution is consistent with that of the reference solution |
| Physical & chemical identification | Positive reaction |
| Clarity and color of solution | Clear and colorless; if color appears, not darker than Yellow No.5 standard solution |
| Related Substances (HPLC) LG-1-B | ≤ 0.1% |
| LG-1-D | ≤ 0.1% |
| LG-C | ≤ 0.1% |
| 1121A | ≤ 0.1% |
| Other individual impurities | ≤ 0.1% |
| Total impurities | ≤ 1.0% |
| Enantiomer | ≤ 0.15% |
| Water | ≤ 3.0% |
| Residue on ignition | ≤ 0.1% |
| Heavy metal | ≤ 20 ppm |
| Sulfate | ≤ 0.01% |
| Chloride | ≤ 0.01% |
| Assay (on anhydrous basis) | 98.0% – 102.0% |
| Bacterial endotoxin | ≤ 3 EU/mg |
| Solvent Residue 1 Methanol | ≤ 0.3% |
| Ethanol | ≤ 0.5% |
| Acetone | ≤ 0.5% |
| Acetonitrile | ≤ 0.041% |
| Dichloromethane | ≤ 0.06% |
| Ethyl acetate | ≤ 0.5% |
| Benzene | ≤ 0.0002% |
| Di-tert-butyl dicarbonate | ≤ 0.1% |
| Solvent Residue 2 N,N,N,N-Tetramethylethylenediamine | ≤ 0.1% |
| N,N-Dimethylformamide | ≤ 0.088% |
| Methyl tert-butyl ether | ≤ 0.5% |
| Tetrahydrofuran | ≤ 0.072% |
| Ethylene glycol dimethyl ether | ≤ 0.1% |
| Trimethylsilyl acetylene | ≤ 0.1% |
| Triethylamine | ≤ 0.5% |
| N,N-Diisopropylethylamine | ≤ 0.1% |
| n-Heptane | ≤ 0.5% |
| Acetic acid | ≤ 0.5% |
| Dimethyl sulfoxide | ≤ 0.5% |
| Aerobic bacterial count | ≤ 10 cfu/g |
| Mould & yeast count | ≤ 100 cfu/g |
| Escherichia coli | ND / 1 g |
| Pseudomonas aeruginosa | ND / 1 g |
Applications
Lifitegrast is primarily used in ophthalmology as an active pharmaceutical ingredient for the management of dry eye disease. It is formulated in topical ophthalmic solutions designed for direct ocular administration, where it acts locally on the ocular surface. Lifitegrast is applied to reduce inflammation associated with chronic dry eye by targeting immune-mediated pathways that contribute to tear film instability and ocular discomfort. Beyond clinical use, it is also employed in pharmaceutical research and development to study inflammatory signaling mechanisms on the ocular surface, as well as in formulation science to optimize drug delivery, bioavailability, and tolerability in eye-drop preparations.
Benefits
Lifitegrast offers several advantages due to its targeted mechanism of action and suitability for localized ocular therapy. By selectively inhibiting interactions involved in inflammatory cell activation, it helps reduce ocular surface inflammation, alleviating symptoms such as dryness, irritation, and visual disturbance. Its topical administration allows high local efficacy with minimal systemic exposure, supporting a favorable safety and tolerability profile. Lifitegrast demonstrates consistent performance in reducing both signs and symptoms of dry eye disease, and its chemical stability enables reliable formulation and storage in ophthalmic products. These characteristics make it well suited for long-term management of chronic ocular conditions.
Conclusion
Lifitegrast is a valuable therapeutic agent in the treatment of dry eye disease, with applications centered on reducing ocular surface inflammation and improving tear film stability. Its benefits, including targeted local action, effective symptom relief, and suitability for topical ophthalmic formulations, make it an important component of modern eye care therapies. The compound continues to support advancements in ophthalmic treatment and research focused on inflammatory eye disorders.
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