Description

Pantoprazole Impurity 11 Dihcl is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Pantoprazole. It is essential for analytical method development, validation, and stability studies to ensure drug safety and efficacy. Pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories require this standard to meet stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Pantoprazole API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Pantoprazole products comply with ICH, USP, and EP impurity limits.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Supports impurity profiling, route scouting, and process chemistry optimization during API synthesis.

Basic Information

Product Name	Pantoprazole Impurity 11 Dihcl
CAS No.	97963-77-4
Molecular Formula	C16H16F2N3O4S • 2HCl
Molecular Weight	477.30 g/mol (for dihydrochloride salt)
Synonyms	Pantoprazole Related Compound H; Pantoprazole Impurity H; 5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Dihydrochloride; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-, dihydrochloride; Pantoprazole EP Impurity H; Pantoprazole USP Related Compound H
EINECS	Contact for details

Quality Control

Every batch of Pantoprazole Impurity 11 Dihcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants and inert conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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