Pantoprazole

Pantoprazole

Paramètre Spécifications
Nom du produit Pantoprazole
Numéro CAS 102625-70-7
Formule moléculaire C16H15F2N3O4S
Poids moléculaire 383.37 g/mol
Apparence Poudre cristalline blanche à blanc cassé
Essai (HPLC) ≥ 99.0% (anhydrous basis)
Solubilité Slightly soluble in water, freely soluble in methanol, practically insoluble in hexane
Colis Fût en fibre de 25 kg avec double revêtement en polyéthylène

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Pantoprazole Structure

Synonymes : Pantoprazole, 5-(Difluoromethoxy)-2-[(3,4-dimethoxy-2-pyridinyl)methylsulfinyl]-1H-benzimidazole, SKF-96022, BY-1023, Pantoloc, Protonix

Pantoprazole is a substituted benzimidazole derivative that acts as a proton pump inhibitor (PPI). Its chemical structure features a difluoromethoxy-substituted benzimidazole ring linked via a methylsulfinyl bridge to a dimethoxypyridine moiety. This configuration allows the molecule to accumulate in the acidic environment of gastric parietal cell canaliculi, where it undergoes acid-catalyzed activation to a reactive sulfenamide that covalently binds to the H+/K+-ATPase enzyme, thereby suppressing gastric acid secretion.

Discovered in the early 1990s, pantoprazole is marketed under brand names such as Protonix and Pantoloc. It is indicated for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and pathological hypersecretory conditions including Zollinger-Ellison syndrome. The compound is also a key API for generic drug manufacturers, and its sodium salt form is commonly used in injectable formulations for acute settings.

In pharmaceutical development, pantoprazole serves as a reference standard for analytical method validation and as a starting material for salt formation and formulation studies. Its selective mechanism and favorable safety profile have made it a staple in both clinical practice and bulk pharmaceutical supply chains.

Structure chimique et propriétés

Pantoprazole belongs to the class of 2-pyridylmethylsulfinyl benzimidazoles. The molecule contains a difluoromethoxy group on the benzimidazole ring, which enhances its lipophilicity and influences its pKa (approximately 3.8 for the pyridine nitrogen). The sulfinyl group is chiral, but pantoprazole is administered as a racemic mixture. It appears as a white to off-white crystalline powder, with a melting point range of 139–141°C (decomposition). The compound is stable under normal storage conditions but degrades in strong acidic media, a property that underlies its targeted activation in vivo.

Mécanisme d'action

  • Proton pump inhibition: Pantoprazole is a prodrug that requires acidic activation. In the parietal cell canaliculus, it is converted to a tetracyclic sulfenamide, which then forms disulfide bonds with cysteine residues on the H+/K+-ATPase, irreversibly blocking acid secretion.
  • Selectivity: Due to its pKa, pantoprazole accumulates preferentially in acidic compartments, minimizing systemic effects on other ATPases.
  • Reversible binding: Unlike some PPIs, pantoprazole shows reversible binding to cysteine 822, but irreversible inhibition of the pump occurs through cysteine 813 and 892.
  • Onset and duration: Acid suppression begins within 1 hour of oral administration, with maximal effect after 2–4 hours. The effect lasts up to 24 hours due to the irreversible nature of the inhibition.

Quality Specifications (QC Tests)

Test Item Spécifications
Identification (IR, HPLC) Complies with reference standard
Perte au séchage ≤ 0,5%
Résidu au feu ≤ 0,11 TP3T
Métaux lourds ≤ 20 ppm
Substances apparentées Total impurities ≤ 0.5%; each unspecified ≤ 0.1%
Limites microbiologiques Total aerobic count ≤ 1000 cfu/g; yeast and mold ≤ 100 cfu/g; E. coli absent

Approvisionnement et documentation

  • Capacité: Up to 5 metric tons per month
  • Délai de livraison: 3 à 5 jours ouvrés (articles en stock)
  • Documentation: COA, MSDS, TDS, and additional regulatory support available upon request
  • Emballage: fûts en fibre de 25 kg avec double revêtement en polyéthylène, ou conditionnement sur mesure pour les petites quantités.

Foire aux questions

What is the minimum order quantity (MOQ) for Pantoprazole?

Our standard MOQ is 1 kg for stock items. For larger quantities, please contact our sales team to discuss volume pricing and availability.

What is the typical delivery time?

For stock items, delivery is 3-5 business days from order confirmation. We ship globally via air or sea freight, depending on your location and preference.

Can you provide a COA and sample for evaluation?

Yes, we provide a COA for every batch and can supply samples for quality evaluation. Samples are typically dispatched within 1-2 days after request, and shipping costs may apply.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

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