Description

Pantoprazole Sodium Sesquihydrate is the active pharmaceutical ingredient (API) form of a proton pump inhibitor used to reduce stomach acid production. This high-purity compound is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers for the production of oral solid dosage forms, such as tablets and capsules, used in the treatment of gastroesophageal reflux disease (GERD) and peptic ulcers.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of pantoprazole-based medications.
• Tablet Formulation: Used in the production of delayed-release or enteric-coated tablets for oral administration.
• Capsule Formulation: Incorporated into capsule dosage forms for the treatment of acid-related disorders.
• Generic Drug Manufacturing: Serves as a key component for generic pharmaceutical companies producing bioequivalent versions.
• Clinical Trial Materials: Supplied as a raw material for the development and production of drugs in clinical research phases.
• Veterinary Pharmaceuticals: Potential application in veterinary medicine for treating acid-related conditions in animals.

Basic Information

Product Name	Pantoprazole Sodium Sesquihydrate
CAS No.	164579-32-2
Molecular Formula	C16H14F2N3NaO4S • 1.5H2O
Molecular Weight	432.38 g/mol (anhydrous basis)
Synonyms	Pantoprazole Sodium Salt Sesquihydrate; Pantoprazole Sodium 1.5-Hydrate; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt Sesquihydrate; BY1023 Sodium Sesquihydrate; SK&F96022 Sodium Sesquihydrate; Protonix API; Pantozol API
EINECS	Contact for details

Quality Control

Our Pantoprazole Sodium Sesquihydrate is manufactured under strict quality systems. We provide material that meets or exceeds relevant pharmacopeial standards, including USP and EP monographs. Every batch undergoes comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis. Certificates of Analysis (COA) documenting full compliance with specifications 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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	5.5% - 7.5%
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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