Description

Lansoprazole Impurity H CAS NO 1346598-28-4 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 (API) Lansoprazole, a widely prescribed proton pump inhibitor. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material (CRM) for the identification and quantification of Impurity H in Lansoprazole drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor and control the levels of specified impurities, ensuring batch-to-batch consistency and product safety.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways in Lansoprazole formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development (R&D): Facilitates chemical and pharmacological research into the synthesis, metabolism, and toxicity profile of Lansoprazole-related compounds.

Basic Information

Product Name	Lansoprazole Impurity H
CAS No.	1346598-28-4
Molecular Formula	C16H14F3N3O2S
Molecular Weight	369.36 g/mol
Synonyms	2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity H; Lansoprazole Related Compound H; Lansoprazole EP Impurity H; Lansoprazole USP Impurity H; AGN 190935 Impurity H; (RS)-Lansoprazole Sulfone; Lansoprazole Sulfoxide Impurity
EINECS	Contact for details

Quality Control

Every batch of Lansoprazole Impurity H is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using advanced techniques such as HPLC, GC, MS, NMR, and IR to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profiles. We support compliance with major pharmacopoeial standards (USP, EP, JP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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%
Assay	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%

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