Description

Pantoprazole Ep Impurity F is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API) Pantoprazole by accurately identifying and quantifying this specific impurity. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D, quality control laboratories, and regulatory affairs to meet stringent pharmacopeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Pantoprazole Ep Impurity F in API and finished dosage forms.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Pantoprazole to monitor impurity profiles and ensure compliance with EP, USP, and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the EMA and FDA.
• Research & Development: Aids in impurity profiling during the synthesis process optimization of Pantoprazole to minimize related substance formation.

Basic Information

Product Name	Pantoprazole Ep Impurity F
CAS No.	721924-06-7
Molecular Formula	C16H14F2N3O4S
Molecular Weight	382.36 g/mol
Synonyms	5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole; Pantoprazole Impurity F; Pantoprazole Related Compound F; Pantoprazole EP Impurity F; 1H-Benzimidazole, 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-; Pantoprazole Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Pantoprazole Ep Impurity F is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for use as a pharmaceutical reference standard. Comprehensive characterization includes identity confirmation (IR, NMR), purity determination (HPLC), and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each batch, documenting all analytical results and confirming compliance with relevant specifications.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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