Description

Omeprazole Related Compound A (15 Mg) (Omeprazole Sulfone) is a high-purity analytical reference standard and a key impurity of the proton pump inhibitor Omeprazole. This compound is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of impurities in active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method validation, stability studies, and regulatory compliance for omeprazole-based medications.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference standard for the identification and quantification of Omeprazole Sulfone in Omeprazole API and related drug formulations.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for impurity analysis.
• Stability Indicating Studies: Employed to assess the degradation pathways and stability of Omeprazole under various stress conditions (e.g., heat, light, humidity).
• Quality Control and Release Testing: Essential for routine QC testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP, ICH guidelines).
• Regulatory Documentation and Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) by demonstrating control over specified and unspecified impurities.
• Research on Drug Metabolism: Acts as a reference marker in studies investigating the metabolic pathways and pharmacokinetics of Omeprazole.

Basic Information

Product Name	Omeprazole Related Compound A (15 Mg) (Omeprazole Sulfone)
CAS No.	88546-55-8
Molecular Formula	C17H19N3O4S
Molecular Weight	361.42 g/mol
Synonyms	Omeprazole Sulfone; 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfonyl]-1H-benzimidazole; 5-Methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfonyl}-1H-1,3-benzodiazole; Omeprazole EP Impurity A; Omeprazole USP Related Compound A; Omeprazole Sulfoxide (common misnomer, correct identity is Sulfone); 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfonyl]-
EINECS	Contact for details

Quality Control

Our Omeprazole Related Compound A is manufactured and tested under strict quality management systems. Each batch is subjected to rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. Our quality commitment aligns with the requirements of current Good Manufacturing Practice (cGMP) and relevant ICH guidelines for impurities in new drug substances.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w
Assay (on dried basis)	97.0% - 103.0%

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