Description

Omeprazole Related Compound 7 Hcl is a high-purity chemical reference standard, specifically identified as a known impurity or degradation product of the proton pump inhibitor Omeprazole. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring the purity, safety, and efficacy of Omeprazole-based drug products.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Omeprazole Active Pharmaceutical Ingredients (APIs) and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in compliance with ICH guidelines.
• Quality Control & Assurance: Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Omeprazole.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Omeprazole.

Basic Information

Product Name	Omeprazole Related Compound 7 Hcl
CAS No.	142913-07-3
Molecular Formula	C₁₇H₂₀ClN₃O₃S
Molecular Weight	381.88 g/mol
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Hydrochloride; Omeprazole Impurity 7 HCl; Omeprazole Related Substance 7 HCl; 5-Methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-1,3-benzodiazole Hydrochloride; UNII-8L669MS4K4; 1H-Benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-, hydrochloride (1:1)
EINECS	Contact for details

Quality Control

Our Omeprazole Related Compound 7 Hcl is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the stringent requirements for a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is hygroscopic (moisture-sensitive); keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single 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.