Description

Omeprazole Impurity 60 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 drug purity, safety, and regulatory compliance. It serves as a key reference material for method development, validation, and stability studies in the production of Omeprazole API and finished dosage forms.

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).
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Omeprazole products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purer synthetic processes for Omeprazole.

Basic Information

Product Name	Omeprazole Impurity 60
CAS No.	121459-89-0
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; Omeprazole Related Compound; 5-Methoxy-1H-benzimidazole-2-thiol, 1-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfoxide; Omeprazole Sulfenamide Derivative; Omeprazole Process Impurity; Omeprazole Degradant; OMZ Impurity 60
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 60 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity, related substances, residual solvents, and spectroscopic data. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
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.