Description

Omeprazole Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of omeprazole, a widely prescribed proton pump inhibitor. It is primarily utilized by pharmaceutical manufacturers and analytical laboratories for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug development and production.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Omeprazole Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and other chromatographic techniques.
• Quality Control & Assurance in pharmaceutical manufacturing to monitor and control impurity profiles as per ICH guidelines.
• Stability Studies to track the formation of degradation products in omeprazole formulations over time.
• Regulatory Compliance and Submission, providing essential data for drug master files (DMFs) and regulatory dossiers for agencies like the FDA and EMA.
• Research and Development of new omeprazole formulations and generic versions.

Basic Information

Product Name	Omeprazole Impurity 14
CAS No.	150054-47-0
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 14; Omeprazole Related Compound 14; 5-Desmethoxy Omeprazole Sulfone; 5-Hydroxy Omeprazole Sulfone; UNII-8JQ5607I5I; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, 5-oxide; Omeprazole EP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs. Comprehensive characterization is performed using advanced techniques like HPLC, MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request to support your regulatory and research needs.

Storage

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

Specification

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

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