Description

Omeprazole Impurity 15 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Omeprazole. This compound is critical for ensuring the purity, safety, and efficacy of Omeprazole-based pharmaceutical formulations by providing a reference for identification and quantification. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and regulatory affairs teams focused on method development and validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Omeprazole API and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against ICH Q3A/B guidelines, ensuring batch-to-batch consistency and compliance.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Pharmacopoeial Testing: Supports testing to meet the specifications of major pharmacopoeias such as USP, EP, BP, and JP.

Basic Information

Product Name	Omeprazole Impurity 15
CAS No.	73590-87-1
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]-, 2-oxide; Omeprazole Sulfenamide; Omeprazole Impurity F (EP); Omeprazole Sulfoxide Derivative; 73590-87-1
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Impurity 15 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques including HPLC, LC-MS, NMR, and IR to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing purity, assay, and impurity profile. Production is aligned with cGMP principles where applicable, supporting its use in regulated pharmaceutical environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool place away from incompatible materials.

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%
Assay	95.0% - 105.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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