Description

Omeprazole Ep Impurity G is a specified impurity used in the quality control and analytical research of the active pharmaceutical ingredient (API) Omeprazole. This compound is critical for ensuring the purity, safety, and efficacy of Omeprazole-based pharmaceutical formulations by serving as a certified reference standard. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing to comply with stringent pharmacopeial standards like the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Omeprazole API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance: Employed in routine quality control testing of Omeprazole batches to ensure compliance with EP, USP, and ICH guidelines for impurity profiles.
• Stability Studies: Used to track the formation of this specific degradation product in Omeprazole under various stability-indicating conditions.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the impurity profile of the drug substance.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and chemistry of Omeprazole.

Basic Information

Product Name	Omeprazole Ep Impurity G
CAS No.	125656-83-9
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 G; Omeprazole Impurity G; Omeprazole Related Compound G; 5-Methoxy-1H-benzimidazole-2-thiol, 1-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]-, S-oxide; Omeprazole Sulfenamide; Omeprazole EP Impurity G; Omeprazole USP Impurity G
EINECS	Contact for details

Quality Control

Every batch of Omeprazole Ep Impurity G is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure it meets the high-purity standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing results for identity, purity (by HPLC), and specified impurities. Our quality protocols are designed to support compliance with ICH Q3A, Q3B, EP, and USP 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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