Pantoprazole Magnesium Hemipentahydrate API is a pharmaceutical proton pump inhibitor salt of pantoprazole used as an active pharmaceutical ingredient in oral acid-suppressing formulations. It belongs to the proton pump inhibitor (PPI) class and provides the pantoprazole active moiety in a magnesium salt form containing 2.5 molecules of water of crystallization.
The correct chemical form is important because Pantoprazole Magnesium Hemipentahydrate is different from Pantoprazole Magnesium Dihydrate, Pantoprazole Magnesium Anhydrous, and Pantoprazole Sodium. FDA's Global Ingredient Archive identifies Pantoprazole Magnesium Hemipentahydrate as a distinct active form under UNII PHN3JS5S59.
Pharmaceutical product monographs identify the drug substance as Magnesium bis(5-(difluoromethoxy)-2-{[(3,4-dimethoxy pyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide) hemipentahydrate. The salt is represented as (C₁₆H₁₄F₂N₃O₄S)₂·Mg·2.5H₂O and has a reported molecular mass of 834.05 g/mol as the salt, with the corresponding pantoprazole base molecular mass of 383.37 g/mol.
Pantoprazole Magnesium Hemipentahydrate belongs to the proton pump inhibitor API category. Pantoprazole inhibits the gastric H⁺/K⁺-ATPase, the enzyme responsible for the final stage of gastric acid secretion by gastric parietal cells.
As a pharmaceutical ingredient, Pantoprazole Magnesium provides the pantoprazole active moiety in a magnesium salt form. The salt form has different physicochemical properties from pantoprazole sodium and other pantoprazole salts, making accurate identification of the solid form important during API manufacturing and pharmaceutical formulation.
Pantoprazole is a substituted benzimidazole proton pump inhibitor. After reaching the acidic secretory canaliculi of gastric parietal cells, pantoprazole undergoes acid-mediated activation and interacts with the gastric proton pump.
The resulting inhibition of H⁺/K⁺-ATPase suppresses the final common pathway of gastric acid secretion. This mechanism allows pantoprazole to reduce both basal and stimulated gastric acid production.
The pharmacological activity comes from the pantoprazole moiety; magnesium and the associated hydrate water define the pharmaceutical salt and solid-state form.
Pantoprazole Magnesium Hemipentahydrate Pharmaceutical API is used in the development and manufacture of oral pharmaceutical products designed to reduce gastric acid secretion. Pantoprazole-containing medicines are associated with the treatment of acid-related gastrointestinal disorders such as gastroesophageal reflux disease (GERD), reflux esophagitis, gastric ulcer and duodenal ulcer.
Pantoprazole products may also be incorporated into therapeutic regimens for Helicobacter pylori eradication and other conditions in which suppression of gastric acid secretion is clinically indicated.
The hemipentahydrate form is particularly relevant to pharmaceutical manufacturing because the solid-state hydrate determines the molecular mass, water content, physical characteristics and formulation calculations of the API.
Published pharmaceutical product monographs describe Pantoprazole Magnesium Hemipentahydrate as an off-white to cream-coloured powder. At 25°C, the reported solubility in water is less than 0.1 mg/mL, described as practically insoluble.
The reported solubility profile includes:
These values are reported at 25°C in pharmaceutical product documentation.
The term hemipentahydrate indicates 2.5 molecules of water per magnesium salt unit represented in the chemical formula. The molecular representation is:
(C₁₆H₁₄F₂N₃O₄S)₂·Mg·2.5H₂O
This is important when calculating assay, water content and dose-equivalent values because the hydrate form has a different molecular mass from anhydrous Pantoprazole Magnesium.
Patent literature describing crystalline Pantoprazole Magnesium Form E identifies it as the hemipentahydrate and reports a water-content range of approximately 5.1–6.2% w/w for that crystalline form.
A Pantoprazole Magnesium Hemipentahydrate API Manufacturer should control both the chemical purity and the physical form of the API. Appropriate analytical characterization may include HPLC or UHPLC assay, related-substance testing, IR identification, water determination by Karl Fischer analysis, elemental impurity testing, residual-solvent testing and solid-state characterization.
Because this is a specific hydrate form, XRPD and water-content determination can be particularly useful for confirming that the supplied material corresponds to the intended hemipentahydrate form.
The FDA substance hierarchy independently identifies Pantoprazole Magnesium Hemipentahydrate as an active form related to Pantoprazole Magnesium and distinct from Pantoprazole Magnesium Dihydrate.
NCATS identifies Pantoprazole Magnesium Hemipentahydrate as racemic with optical activity listed as (+/−). The substance representation contains no defined stereocenters in the racemic form.
Therefore, a conventional enantiomeric-purity specification should only be included when the supplied material is specifically controlled for a particular pantoprazole enantiomer.
Pantoprazole Magnesium Hemipentahydrate Bulk API should be manufactured under appropriate pharmaceutical quality systems with controlled raw materials, validated processing, impurity monitoring and solid-state characterization.
Particular attention should be given to:
For regulatory or commercial documentation, the exact API specification should be aligned with the manufacturer's approved specification and the target market's applicable pharmacopoeial and regulatory requirements.
A Pantoprazole Magnesium Hemipentahydrate API Supplier India may provide:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Water Content | 5.1–6.2% |
| Melting Point | Approximately 175°C |