HOME

OMEPRAZOLE

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;

 

 

CAS NO.:

73590-58-6 (Base)

 

EINECS NO.:

N/A

 

FORMULA:

C17H18N3O3S·Na

 

H.S. CODE:

29350090

 

CLASS NO.:

N/A

 

UN NO.:

N/A

 

NFPA:

1-1-0-E

 

DESCRIPTION:

white to off-white crystalline powder.

 

APPLICATION

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.

SPECIFICATION & PACKING

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
Packing: 25KG/DRUM

Storage: Moisture sensitive. Keep container tightly closed. Keep container in a cool, well-ventilated area. Preferably freeze (Store between -25°C (-13°F) and -30 C). Otherwise, keep refrigerated.

RAW MATERIAL:

N/A

END GOODS:

N/A

REMARKS:

N/A

MATERIAL SAFE DATA SHEETS

Section 1: Chemical Product and Company Identification

Product Name: Omeprazole

CAS#: 73590-58-6

Synonym: Losec; Pepticum; Ulceral; Antra; Aulcer; Elgam;

Omapren; Prilosec

Chemical Name: Omeprazole

Chemical Formula: C17-H19-N3-O3-S

Section 2: Composition and Information on Ingredients

Composition:

Name           CAS #            % by Weight

Omeprazole    73590-58-6             100

Toxicological Data on Ingredients: Omeprazole: ORAL (LD50): Acute: >4000 mg/kg [Mouse]. 2210 mg/kg [Rat].

Section 3: Hazards Identification

Potential Acute Health Effects:

Hazardous in case of inhalation (lung irritant). Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, .

Potential Chronic Health Effects:

CARCINOGENIC EFFECTS: Not available.

MUTAGENIC EFFECTS: Not available.

TERATOGENIC EFFECTS: Not available.

DEVELOPMENTAL TOXICITY: Not available.

The substance may be toxic to gastrointestinal tract.

Repeated or prolonged exposure to the substance can produce target organs damage.

Section 4: First Aid Measures

Eye Contact:

Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Cold water may be used. WARM water MUST be used. Get medical attention.

Skin Contact:

In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get medical attention.

Serious Skin Contact: Not available.

Inhalation:

If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.

Serious Inhalation: Not available.

Ingestion:

Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an

unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if

symptoms appear.

Serious Ingestion: Not available.

Section 5: Fire and Explosion Data

Flammability of the Product: May be combustible at high temperature.

Auto-Ignition Temperature: Not available.

Flash Points: Not available.

Flammable Limits: Not available.

Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...).

Fire Hazards in Presence of Various Substances:

Slightly flammable to flammable in presence of heat.

Non-flammable in presence of shocks.

Explosion Hazards in Presence of Various Substances:

Risks of explosion of the product in presence of mechanical impact: Not available.

Risks of explosion of the product in presence of static discharge: Not available.

Fire Fighting Media and Instructions:

SMALL FIRE: Use DRY chemical powder.

LARGE FIRE: Use water spray, fog or foam. Do not use water jet.

Special Remarks on Fire Hazards: Not available.

Special Remarks on Explosion Hazards: Not available.

Section 6: Accidental Release Measures

Small Spill:

Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by

spreading water on the contaminated surface and dispose of according to local and regional authority

requirements.

Large Spill:

Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate through the sanitary system.

Section 7: Handling and Storage

Precautions:

Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the

residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. If

ingested, seek medical advice immediately and show the container or the label. Keep away from incompatibles such as oxidizing agents.

Storage:

Moisture sensitive. Keep container tightly closed. Keep container in a cool, well-ventilated area. Preferably freeze (Store between -25°C (-13°F) and -30 C). Otherwise, keep refrigerated.

Section 8: Exposure Controls/Personal Protection

Engineering Controls:

Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below

recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

Personal Protection:

Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves (impervious).

Personal Protection in Case of a Large Spill:

Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

Exposure Limits: Not available.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid. (Crystals solid. Crystalline solid.)

Odor: Not available.

Taste: Not available.

Molecular Weight: 345.42 g/mole

Color: Off-white. White.

pH (1% soln/water): Not available.

Boiling Point: Not available.

Melting Point: 156°C (312.8°F)

Critical Temperature: Not available.

Specific Gravity: Not available.

Vapor Pressure: Not applicable.

Vapor Density: Not available.

Volatility: Not available.

Odor Threshold: Not available.

Water/Oil Dist. Coeff.: The product is more soluble in oil; log(oil/water) = 2.2

Ionicity (in Water): Not available.

Dispersion Properties: See solubility in water, methanol, acetone.

Solubility:

Easily soluble in methanol.

Partially soluble in acetone.

Very slightly soluble in cold water, hot water.

Section 10: Stability and Reactivity Data

Stability: The product is stable.

Instability Temperature: Not available.

Conditions of Instability: Elevated temperatures, moisture, incompatible materials

Incompatibility with various substances: Reactive with oxidizing agents.

Corrosivity: Not available.

Special Remarks on Reactivity: Moisture sensitive

Special Remarks on Corrosivity: Not available.

Polymerization: Will not occur.

Section 11: Toxicological Information

Routes of Entry: Inhalation. Ingestion.

Toxicity to Animals: Acute oral toxicity (LD50): 2210 mg/kg [Rat].

Chronic Effects on Humans: May cause damage to the following organs: gastrointestinal tract.

Other Toxic Effects on Humans:

Hazardous in case of inhalation (lung irritant).

Slightly hazardous in case of skin contact (irritant), of ingestion, .

Special Remarks on Toxicity to Animals: Not available.

Special Remarks on Chronic Effects on Humans:

May cause adverse reproductive effects based on animal data.

May affect genetic material.

May cross the placenta.

Special Remarks on other Toxic Effects on Humans:

Acute Potential Health Effects:

Skin: May cause skin irritation.

Eyes: Dust may cause eye irritation.

Inhalation: Dust may cause respiratory tract irritation.

Ingestion: May cause digestive tract irritation with nausea, vomiting, hypermotility, and diarrhea. May also affect, blood (Eosinophilia, Normocytic anemia), metabolism, brain, behavior (ataxia, convulsions, sedation, change in motor activity, decreased activity), respiration (dyspnea, coughing, decreased respiration, plerual effusion, ptosis), liver (jaundice, hepatitis), immune system, urinary system/kidneys, and cause musculoskeletal effects.

Section 12: Ecological Information

Ecotoxicity: Not available.

BOD5 and COD: Not available.

Products of Biodegradation:

Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.

Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.

Special Remarks on the Products of Biodegradation: Not available.

Section 13: Disposal Considerations

Waste Disposal:

Waste must be disposed of in accordance with federal, state and local environmental

control regulations.

Section 14: Transport Information

DOT Classification: Not a DOT controlled material (United States).

Identification: Not applicable.

Special Provisions for Transport: Not applicable.

Section 15: Other Regulatory Information

Federal and State Regulations: No products were found.

Other Regulations: Not available.

Other Classifications:

WHMIS (Canada): Not controlled under WHMIS (Canada).

DSCL (EEC):

R36/37/38- Irritating to eyes,

respiratory system and skin.

S26- In case of contact with eyes, rinse

immediately with plenty of water and seek

medical advice.

S36- Wear suitable protective clothing.

HMIS (U.S.A.):

Health Hazard: 1

Fire Hazard: 1

Reactivity: 0

Personal Protection: E

National Fire Protection Association (U.S.A.):

Health: 1

Flammability: 1

Reactivity: 0

Specific hazard:

Protective Equipment:

Gloves (impervious).

Lab coat.

Dust respirator. Be sure to use an

approved/certified respirator or

equivalent.

Safety glasses.

 

Section 16: Other Information

References: Not available.

Other Special Considerations: Not available.

SPECIAL DESCRIPTION

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;