Description

Pantoprazole Sodium is the sodium salt form of pantoprazole, a proton pump inhibitor (PPI) that acts as a potent and long-lasting suppressant of gastric acid secretion. This active pharmaceutical ingredient (API) is critical for the formulation of effective and reliable anti-ulcer medications. It is primarily utilized by pharmaceutical manufacturers in the production of solid oral dosage forms, such as enteric-coated tablets and delayed-release capsules, for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of prescription and generic proton pump inhibitor medications.
• Tablet Formulation: Used in the production of delayed-release or enteric-coated tablets to ensure targeted release in the small intestine.
• Capsule Formulation: Incorporated into delayed-release capsules for the treatment of acid-related gastrointestinal disorders.
• Combination Therapies: Can be formulated in combination with other APIs, such as antibiotics for Helicobacter pylori eradication regimens.
• Clinical Research: Serves as a reference standard and raw material in pharmaceutical R&D for developing new gastroprotective formulations.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished dosage forms.

Basic Information

Product Name	Pantoprazole Sodium
CAS No.	699002-47-6
Molecular Formula	C16H14F2N3NaO4S
Molecular Weight	405.35 g/mol
Synonyms	Pantoprazole Sodium Sesquihydrate; Sodium 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; BY1023 Sodium Salt; SK&F96022 Sodium; Pantoprazole Sodium Salt; Pantozol Sodium; Protonix Sodium Salt
EINECS	Contact for details

Quality Control

Our Pantoprazole Sodium is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards, including USP (United States Pharmacopeia) and EP (European Pharmacopoeia) monographs where applicable. Each batch undergoes comprehensive analytical testing for identity, purity, potency, and impurity profiles using validated methods such as HPLC and spectroscopy. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to ensure full traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after each use to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Conforms to standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 8.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP

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