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BP - British Pharmacopoeia CP - Chinese Pharmacopoeia EP - European Pharmacopoeia JP - Japanese Pharmacopoeia USP - United States Pharmacopoeia
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Product Name : PANTOPRAZOLE SODIUM SALT
C.A.S. No: 138786-67-1
Synonyms : Sodium-[5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyri - dinyl)-methyl]-sulfinyl]-1H-benzimidazolide
Molecular Formula: C₁₆H₁₄F₂N₃NaO₄S₁.₅ H₂O
Formula Weight : 432.4
Product Group: Antiulcerative 

Pantoprazole Sodium is a substituted benzimidazole proton-pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the gastric (H+,K+)-ATPase enzyme pump. Pantoprazole Sodium forms a covalent bond to two sites of the (H+,K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell; this binding results in antisecretory effects that persists for more than 24 hours. A significant increase in gastric pH and decrease in basal acid output follow oral and IV administration of Pantoprazole Sodium. Pantoprazole Sodium does not antagonize H2 or cholinergic receptors.

Most studies report that gastric acid suppression is dose-related following IV and oral administration of Pantoprazole Sodium, resulting in inhibition of both basal and stimulated gastric acid secretion (irrespective of the stimulus).

Significant in vitro activity against Helicobacter pylori (H. Pylori) has been demonstrated for Pantoprazole Sodium.
Similar to omeprazole and other PPIs, hypergastrinemia can occur during Pantoprazole Sodium therapy. Although prolonged hypergastrinemia has been associated with gastric tumors in rats, long-term studies of proton pump inhibitors do not suggest the development of tumors in humans.

No clinically relevant effects of Pantoprazole Sodium on cardiovascular, respiratory, ophthalmic, or central nervous system function have been detected. A short-term (2-week) evaluation showed that oral Pantoprazole Sodium had no effect on endocrine hormones including: cortisol, testosterone, triiodothyronine (T3), thyroxine (T4), thyroid-stimulating hormone, thyronine-binding protein, parathyroid hormone, insulin, glucagon, renin, aldosterone, follicle-stimulating hormone, luteinizing hormone, prolactin and growth hormone.

HAZARDS IDENTIFICATION

Not considered hazardous when handled under normal conditions with good house keeping.
  

FIRE FIGHTING MEASURES

Extinguishing Media:
Carbon dioxide, dry chemical powder or appropriate foam. Water spray.

Unusual fire and explosion hazards:
Emits toxic fumes under fire conditions

Special fire fighting procedures:
Wear self-contained breathing apparatus and protective clothing to prevent contact with the skin and eyes.

Accidental Release Measures:
Ensuring personal safety, mark out contaminated area with signs and prevent unauthorized access. Turn leaking containers up to prevent further Evaculate area. Wear self-contained breathing apparatus, rubber boots & heavy rubber gloves. Sweep-up/absorb in suitable material, place in a container and hold for disposal. Avoid raising dust. Ventilate area and wash spill site after pick-up complete.

Handling and Storage:
Store in original container in a cool dark place.

EXPOSURE CONTROL/PERSONAL PROTECTION:

Respiratory protection: required when dusts are generated.
Eye protection:    required.
Hand protection:  required.
Industrial hygiene: Immediately change contaminated clothing. Wash hands and face after working with substance.

PHYSICAL AND CHEMICAL PROPERTIES:

Appearance                 White to off-white powder

Ecological Information  Do not allow product to enter drinking water supplies, waste water or soil!

DISPOSAL CONSIDERATIONS:

Dissolve or mix material with a suitable combustible solvent and incinerate in a chemical incinerator equipped with an afterburner and scrubber. Material should be disposed of in keeping with all local and national legislation. Packaging should be disposed of in keeping with all local and national legislation. Handle contaminated containers as product.

TRANSPORT INFORMATION:

Classification:
UN Number:

While the information herein is believed to be reliable, it is furnished without warranty of any kind. It shall be used only as a guide. We assume no liabilities from the use of this product or information contained herein.

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