1. Product Information
Product Name: Omeprazole
Cas No.: 73590-58-6
Molecular Formula: C17H19N3O3S
Molecular Weight: 345.42
2. Uses:
Omeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. It is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).
3. Specification:
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TEST ITEM |
STANDARDS REQUIRED |
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Characters Identification IR Test Appearance of solution Absorbance
Related substances(HPLC) Impurity D E Any other individual impurity Total impurities Residual solvents: a)Acetone b)Methylene chloride c)Methanol d)Toluene e)Benzene Loss on drying Sulphated ash Assay% on dry basis
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A white or almost white powder
IR Conforms to the CRS (2.2.24)
Solution S is clear (2.2.1) The absorbance is not greater than 0.10 at 440nm(2.2.25) (2.2.29) ≤0.15% ≤0.15% ≤0.10% ≤0.5%
≤1500ppm ≤100ppm ≤1000ppm ≤300ppm ≤1ppm ≤0.2%(2.2.32) ≤0.1%(2.4.14) 99.0%-101.0%(2.2.20) |