Description

Omeprazole Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of Omeprazole, a widely prescribed proton pump inhibitor. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product by accurately identifying and quantifying related substances. It is essential for research and development, method validation, and regulatory compliance within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Omeprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Omeprazole.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to track the formation of degradation products in Omeprazole under various stress conditions (e.g., heat, light, humidity).
• Research on Degradation Pathways: Aids in understanding the chemical stability and degradation mechanisms of Omeprazole.

Basic Information

Product Name	Omeprazole Impurity 7
CAS No.	2250243-45-7
Molecular Formula	C₁₇H₁₉N₃O₃S
Molecular Weight	345.42 g/mol
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 7; Omeprazole Related Compound 7; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]- (specified impurity); Omeprazole Sulfone N-Oxide (proposed); UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. This material is hygroscopic (moisture-sensitive) and must be handled under anhydrous conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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