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 high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective and reliable medications targeting acid-related gastrointestinal disorders. It is primarily utilized by pharmaceutical manufacturers in the development and production of solid oral dosage forms, such as enteric-coated tablets and delayed-release capsules.

Application

• Pharmaceutical API: Core active ingredient in prescription and generic medications for the treatment of gastroesophageal reflux disease (GERD), erosive esophagitis, and Zollinger-Ellison syndrome.
• Tablet Formulation: Used in the manufacture of delayed-release or enteric-coated tablets to ensure the API is released in the small intestine, bypassing degradation in the stomach's acidic environment.
• Capsule Formulation: Incorporated into delayed-release capsules for oral administration, offering an alternative dosage form.
• Combination Therapies: May be formulated in combination with antibiotics (e.g., amoxicillin, clarithromycin) for Helicobacter pylori eradication regimens.
• Clinical Research: Serves as a reference standard and raw material for bioavailability, bioequivalence, and new drug development studies.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for the management of gastric ulcers and acid-related disorders in animals.

Basic Information

Product Name	Pantoprazole Sodium
CAS No.	138786-67-1
Molecular Formula	C16H14F2N3NaO4S
Molecular Weight	405.35 g/mol
Synonyms	Pantoprazole Sodium Salt; Sodium Pantoprazole; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Sodium Salt; BY1023 Sodium Salt; SK&F96022 Sodium Salt; Pantozol Sodium; Protonix (Brand Name Sodium Salt Form); Pantoprazole Sodium Sesquihydrate (common hydrated form)
EINECS	Contact for details

Quality Control

Our Pantoprazole Sodium is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, potency, and impurity profiles, aligning with major pharmacopoeial standards such as USP, EP, and IP. A detailed Certificate of Analysis (COA) is provided with each batch, confirming compliance with your required specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated 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 and clumping.

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 Content (KF)	≤ 2.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%
pH (1% Solution)	9.0 - 11.0

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