Description

Pantoprazole Sodium Sesquihydrate is the active pharmaceutical ingredient (API) of the proton pump inhibitor pantoprazole. This compound is critical for the formulation of highly effective medications used to treat gastric acid-related disorders. It is primarily required by pharmaceutical manufacturers for the production of solid oral dosage forms, such as tablets and capsules, for global therapeutic markets.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and generic drug formulations.
• Gastroesophageal Reflux Disease (GERD) Treatment: Formulated into delayed-release tablets for managing acid reflux and heartburn.
• Erosive Esophagitis Therapy: Used in medications for healing and symptom relief of esophageal damage caused by stomach acid.
• Zollinger-Ellison Syndrome Management: A key component in drugs prescribed for this rare acid hypersecretion condition.
• Peptic Ulcer Disease Treatment: Incorporated into formulations for duodenal and gastric ulcer therapy.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for cost-effective, bioequivalent product development.

Basic Information

Product Name	Pantoprazole Sodium Sesquihydrate
CAS No.	154644-14-1
Molecular Formula	C16H14F2N3NaO4S • 1.5H2O
Molecular Weight	432.38 g/mol (Sesquihydrate)
Synonyms	Pantoprazole Sodium Salt Sesquihydrate; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt Sesquihydrate; BY1023 Sodium Sesquihydrate; SK&F96022 Sodium Sesquihydrate; Pantozol Sodium Sesquihydrate; Protonix API; Pantoprazole Sodium 1.5-Hydrate
EINECS	Contact for details

Quality Control

Our Pantoprazole Sodium Sesquihydrate is manufactured under strict quality management systems. It is tested to meet high-purity standards suitable for pharmaceutical applications, with specifications aligning with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) documenting identity, purity, and impurity profiles is provided with each batch to ensure traceability and regulatory compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	5.0% - 7.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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