Description

Pantoprazole is a proton pump inhibitor (PPI) API, a key therapeutic agent for reducing gastric acid production. Its high purity and consistent quality are critical for ensuring the efficacy and safety of final pharmaceutical formulations. This compound is essential for manufacturers in the global pharmaceutical industry developing treatments for acid-related disorders such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in prescription and generic medications for acid suppression.
• Oral Solid Dosage Forms: Formulation into delayed-release tablets and capsules, including combination therapies.
• Injectable Formulations: Used in the production of sterile intravenous (IV) pantoprazole for hospital and clinical settings.
• Generic Drug Manufacturing: Sourcing for companies producing bioequivalent versions of branded pantoprazole drugs.
• Clinical Research & Development: Serves as a reference standard and raw material in preclinical and clinical studies for new gastrointestinal treatments.
• Contract Manufacturing Organizations (CMOs): Supplied to CMOs and CDMOs for toll manufacturing and finished dosage form production.

Basic Information

Item	Detail
Product Name	Pantoprazole
CAS No.	102625-70-7
Molecular Formula	C16H15F2N3O4S
Molecular Weight	383.37 g/mol
Synonyms	Pantoprazole Sodium; Pantoprazole Free Acid; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; BY1023; SK&F96022 Pantozol; Protonix; Pantoloc; Controloc; Zurcal; Pantecta; Pan; PPI-101
EINECS	Contact for details

Quality Control

Our Pantoprazole is manufactured and tested under strict quality management systems. It is produced to meet or exceed relevant pharmacopoeial standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs. Every batch undergoes comprehensive analytical testing for identity, purity, potency, and specified impurities. Certificates of Analysis (COA) documenting full compliance are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.