Nepafenac 78281-72-8

98% up by HPLC

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Product Details

Product Information

Product name	Nepafenac
CAS No.	78281-72-8
Molecular Formula	C15H14N2O2
Molecular Weight	86.18
Molecular Structure
Quality Standard	98% up by HPLC
Appearance	Yellow or light yellow crystalline powder

COA

ANALYSIS	SPECIFICATION	RESULTS
Appearance	Yellow or light yellow crystalline powder	Conforms
Solubility	Free soluble in dimethyl sulfoxide, insoluble in water, sparingly soluble in tetrahydrofuran, slightly soluble in methanol and acetonitrile.	Conforms
Individual impurity	≤ 0.2%	0.04%
Total impurity	≤ 0.5%	0.10%
Impurity A	≤ 0.1%	ND
Acetonitrile	≤0.041%	ND
Isopropanol	≤0.5%	0.22%
Tetrahydrofuran	≤ 0.072%	ND
Dichloromethane	≤0.06%	ND
Loss on dying	≤0.5%	0.2%
Sulphated ash	≤0.1%	0.07%
Heavy metals	≤0.002%	< 0.002%
Assay((on dried bases)	98.0% - 101.5%	99.5%
Conclusion	The product meets the above specification

Usage

What is Nepafenac?

Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop 0.1% solution or 0.3% solution. Nepafenac is used to treat pain and inflammation associated with cataract surgery. Nepafenac is a prodrug of amfenac, an inhibitor of COX-1 and COX-2 activity, thought to be a prodrug of amfenac after conversion by ocular tissue hydrolases after penetration via the cornea. Like other NSAIDs, is thought to inhibit cyclooxygenase action. In the European Union nepafenac is also indicated for the reduction in the risk of postoperative macular edema associated with cataract surgery in people with diabetes.