Product Name: Loteprednol etabonate

CAS No.: 82034-46-6

Batch No.: 20180503

Report Date: 20180503

Perform Standard: Enterprise Standard

Items

Standards

Results

Appearance

White to almost white powder

Almost white powder

Identification

1. The infrared absorption is same as reference

Conforms

2. Max. absorption is in the wavelength 245nm

Conforms

Related substances

Individual impurity: NMT 0.2%

0.06%

Total impurities: NMT 0.5%

0.13%

Loss on drying

≤0.5%

0.19%

Methanol

≤0.3%

ND

Acetone

≤0.5%

0.13%

Chlorides

≤0.01%

Conforms

Heavy metals

≤10ppm

Conforms

Assay (on dried basis, by titration)

98.0%~102.0%

99.6%