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Active Pharmaceuticals

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  • Specifications
  • depictio producti
  • Product Syntaxis
  • COA
Product Name
Omeprazol
CAS
73590-58-6
EINECS No
/
Aspectus
Album vel fere album crystallinum pulveris
MF
C17H19N3O3S
M. Pondus
345.42
Puritas
99%
Solubilitas
Easily soluble in dichloromethane, slightly soluble in methanol or ethanol, slightly soluble in acetone, insolubilem aquam

Omeprazole, sold under the brand names Prilosec and Losec among others, is a medication used in the treatment of gastroesophageal reflux disease, peptic ulcer disease, and Zollinger–Ellison syndrome. It is also used to prevent upper gastrointestinal bleeding in people who are at high risk. It can be taken by mouth or injected into a vein.

Omeprazole is used to reduce the amount of acid in your stomach. It’s used to treat gastric or duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (inflammation in the esophagus), and hypersecretory conditions (conditions where your stomach makes too much acid). This drug is also used to treat stomach infections caused by the bacteria Helicobacter pylori.

Omeprazole belongs to a class of drugs called proton pump inhibitors (PPIs). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Omeprazole works by decreasing the amount of acid your stomach produces. It does this by blocking the proton pump in the cells of your stomach.

The proton pump works in the final step of acid production. When the proton pump is blocked, your stomach makes less acid. This should decrease your symptoms.

ITEMS
STANDARD
RESULTS
Aspectus
Album vel fere album crystallinum pulveris
Complies
Lepidium sativum
A:
By TLC
Complies
B:
IR Conforms to standard
Complies
Completeness of solution
Conforms to standard
Complies
Color of solution
The absorbance is not greater than 0.1 at 440nm
0.04
Damnum in siccitate
≤0.5%
0.20%
Reliqua ignitio
≤0.1%
0.04%
Metalla gravis
≤0.002%
<0.002%
Chromatographic purity
(HPLC)
Single impurity
≤0.3%
0.12%
Total impurity
≤1.0%
0.28%
Residual solvent
a)Acetone
≤ 5000ppm
554ppm
b)Methylene
≤600ppm
12ppm
c)Methanol
≤ 3000ppm
50ppm
d*)Toluene
≤ 890ppm
28ppm
Assay(HPLC)
98.5%-100.0%
98.5%

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