Description

Pantoprazole Magnesium is the magnesium salt form of the proton pump inhibitor pantoprazole, offering enhanced stability and handling properties. This active pharmaceutical ingredient (API) is critical for the formulation of long-acting, effective medications to treat gastric acid-related disorders. It is primarily required by pharmaceutical manufacturers for the production of solid oral dosage forms, such as delayed-release tablets.

Application

• Pharmaceutical API: Core active ingredient in the manufacture of pantoprazole magnesium delayed-release tablets.
• Gastroesophageal Reflux Disease (GERD) Treatment: Used in medications for the healing and symptomatic relief of erosive esophagitis.
• Peptic Ulcer Therapy: Key component in drugs for the treatment of duodenal and gastric ulcers.
• Zollinger-Ellison Syndrome Management: Employed in formulations for the long-term treatment of pathological hypersecretory conditions.
• Combination Therapies: Can be formulated in combination with antibiotics for Helicobacter pylori eradication regimens.
• Generic Drug Production: Essential for manufacturers producing bioequivalent generic versions of branded pantoprazole medications.

Basic Information

Product Name	Pantoprazole Magnesium
CAS No.	1022083-88-0
Molecular Formula	C34H32F2MgN6O8S2
Molecular Weight	767.09 g/mol
Synonyms	Pantoprazole Magnesium Salt; Pantoprazole Mg; Magnesium Pantoprazole; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Magnesium Salt; BY1023 Magnesium Salt; SKF96022 Magnesium Salt; Protonix API; Pantoloc API
EINECS	Contact for details

Quality Control

Our Pantoprazole Magnesium is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results is provided with each shipment to ensure full traceability and regulatory compliance for our pharmaceutical partners.

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 container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
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/JP/USP

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