OMEPRAZOLE SODIUM

PRODUCT IDENTIFICATION

CAS NO. 73590-58-6, (Base)
95510-70-6 (Sodium)

OMEPRAZOLE

EINECS NO.  
FORMULA C17H18N3O3S·Na
MOL WT. 366.82

H.S. CODE

 

TOXICITY

 
SYNONYMS Losev; Omeprazole; Prilosec;

(R,S)-5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]- 1H-benzimidazole monosodium salt; Losec Sodium; Omepral; Andra; Sodium 5-methoxy-2-[(4-methoxy-3,5- dimethyl-pyridin-2-yl)methylsulfinyl]benzoimidazole;

SMILES

 

CLASSIFICATION

 PROTON PUMP INHIBITORS /

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE white to off-white crystalline powder
MELTING POINT  
BOILING POINT  
SPECIFIC GRAVITY  
SOLUBILITY IN WATER Soluble
pH  
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 

FLASH POINT  
STABILITY

Stable under ordinary conditions.

APPLICATIONS

Proton Pump Inhibitors (PPIs) are a group of drugs to reduce the production of acid by blocking the enzyme (hydrogen-potassium adenosine triphosphatase) in parietal cells that produces acid. They are used in the treatment of ulcers caused by taking nonsteroidal anti-inflammatory drugs, Zollinger-Ellison syndrome, and symptomatic gastroesophageal reflux disease. They are also used in eradicating Helicobacter pylori, in combination with antibiotics (e.g. amoxycillin, clarithromycin or metronidazole in case of penicillin-hypersensitive patients). Another lowering-acid medicines are H2 antagonist drugs which reduce the production of acid by blocking the H2 subtype of histamine receptors.

Commecially available PPIs include;

  • Omeprazole (CAS RN: 73590-58-6)
  • Lansoprazole (CAS RN: 103577-45-3)
  • Esomeprazole (CAS RN: 161796-78-7)
  • Pantoprazole (CAS RN: 102625-70-7)
  • Rabeprazole (CAS RN: 117976-89-3)

Omeprazole, a substituted benzimidazole, is a PPI used in the treatment of symptomatic gastroesophageal reflux disease and in combination with clarithromycin duodenal ulcer associated with Helicobacter pylori infection. It is a white to off-white crystalline powder; melts or decomposes at 155 C; very slightly soluble in water; slightly soluble in acetone, isopropanol; freely soluble in ethanol and methanol; administered orally.  It is a weak base; unstable under acid conditions, but stable in alkaline media. The chemical designation is (R,S)-5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]- 1H-benzimidazole.

SALES SPECIFICATION

APPEARANCE

white to off-white crystalline powder

IDENTIFICATION

Complies Test A,B,C

ASSAY (HPLC)

98.5 - 101.5%

pH

10.3 - 11.3 (0.02mg/ml solution)

SOLVENT RESIDUE

0.01% max

SULFATED ASH

0.1% max

HEAVY METALS

20ppm max

LOSS ON DRYING

0.1% max

TRANSPORTATION
PACKING
 
HAZARD CLASS  
UN NO.  
OTHER INFORMATION
Hazard Symbols: XN, Risk Phrases: 20/21/22, Safety Phrases: 36
PRICES

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