Description

Pantoprazole Sodium Hydrate is the sodium salt form of a proton pump inhibitor (PPI) used as a key active pharmaceutical ingredient (API). It is a high-purity compound essential for the formulation of effective and stable anti-ulcer medications. This product is primarily required by pharmaceutical manufacturers for the production of solid dosage forms, such as tablets and capsules, and is critical for research and development in gastroenterology.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the manufacture of anti-ulcer and anti-gastroesophageal reflux disease (GERD) medications.
• Formulation of delayed-release tablets and enteric-coated capsules to ensure targeted drug delivery in the intestine.
• Production of generic pharmaceutical products containing pantoprazole.
• Use in clinical research and development for new therapeutic applications of proton pump inhibitors.
• Preparation of reference standards and analytical markers for quality control laboratories.
• Potential use in veterinary pharmaceutical formulations for treating acid-related disorders in animals.

Basic Information

Product Name	Pantoprazole Sodium Hydrate
CAS No.	718635-09-7
Molecular Formula	C16H14F2N3NaO4S • xH2O
Molecular Weight	405.36 g/mol (Anhydrous basis)
Synonyms	Pantoprazole Sodium Sesquihydrate; Sodium 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Hydrate; Pantoprazole Sodium Salt Hydrate; BY1023 Sodium Salt; SK&F96022 Sodium; Pantozol Sodium; Protium Sodium Salt; Pantoprazole Na Hydrate; Pantoprazole Sodium
EINECS	Contact for details

Quality Control

Our Pantoprazole Sodium Hydrate is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use, including identity, assay, impurity profile, and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications. We support compliance with major pharmacopoeial standards, including USP and EP.

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) and must be kept in a dry environment to prevent degradation. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC, on anhydrous basis)	98.0% - 102.0%
Water Content (KF)	4.0% - 6.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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