Pharmaceutical grade Loteprednol Etabonate Raw

描述

Loteprednol  Description

Loteprednol (as the ester loteprednol etabonate) is a corticosteroid used to treat inflammations of the eye. It is marketed by Bausch and Lomb as Lotemax.

Loteprednol (as Loteprednol Etabonate) is a topical anti-inflammatory corticosteroid. Loteprednol etabonate (LE) has a 17α-chloromethyl ester, in lieu of a ketone group, and a 17β-etabonate group. LE is highly lipophilic and binds with high affinity to the glucocorticoid receptor. Any unbound LE is metabolized to inactive metabolites.
Loteprednol etabonate is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitis. It is used in ophthalmic ointment for the treatment of post-operative inflammation and pain following ocular surgery. As a nasal spray, it is used for the treatment and management of seasonal allergic rhinitis.

Specification

Items	Specification
Appearance	A white to off white powder
Particle size（optical microscopy）	90%≤10um
Identification	1.The infrared absorption is same as reference. 2Max absorption is in the wavelength 245nm
Loss on drying	≤0.5%
Individual impurity	≤0.2%
Total impurities	≤0.5%
Methanol	≤0.3%
Acetone	≤0.5%
Chlorides	≤0.01%
Residue on ignition	≤0.1%
Heavy Metals	≤0.001%
Sterility test	Should meets the requirements
Assay	98.0%~ 102.0%
Conclusion	Conform to the factory’s standard