Description

Lansoprazole Impurity 34 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 the active pharmaceutical ingredient Lansoprazole, a widely prescribed proton pump inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Lansoprazole drug substance and finished products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products during forced degradation and long-term stability testing of Lansoprazole formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D to study the degradation pathways, synthesis pathways, and metabolic profiles of Lansoprazole.
• Quality Control Testing: Acts as a system suitability standard and a calibrant for routine batch release testing in pharmaceutical manufacturing.

Basic Information

Product Name	Lansoprazole Impurity 34
CAS No.	1357726-93-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lansoprazole Related Compound 34; Lansoprazole EP Impurity I; Lansoprazole USP Impurity; Lansoprazole Degradation Product; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity; Lansoprazole Sulfoxide Impurity; Lansoprazole Process Impurity
EINECS	Contact for details

Quality Control

Our Lansoprazole Impurity 34 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, 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. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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.