Description

Iprazole Impurity 33 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products, specifically in the development and manufacturing of proton pump inhibitors. It serves as a key impurity marker for researchers and quality control laboratories in the pharmaceutical industry who require precise analytical standards for method validation and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to ensure accurate detection and separation.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to monitor impurity levels and ensure product consistency against pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving synthetic routes for related pharmaceutical compounds.

Basic Information

Product Name	Iprazole Impurity 33
CAS No.	172152-43-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole Impurity 33; Omeprazole Related Compound 33; 5-Methoxy-1H-benzimidazole-2-thiol, 1-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-; Omeprazole Sulfenamide Derivative; PPI Impurity 33; Proton Pump Inhibitor Impurity 33
EINECS	Contact for details

Quality Control

Every batch of Iprazole Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light) and hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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