Description

Lansoprazole Impurity 3 is a high-purity 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 & Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure product meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Lansoprazole formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, pharmacokinetic research, and to understand the degradation pathways of Lansoprazole.

Basic Information

Item	Detail
Product Name	Lansoprazole Impurity 3
CAS No.	1329838-16-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lansoprazole Related Compound 3; Lansoprazole Impurity C; Lansoprazole EP Impurity C; Lansoprazole USP Impurity; 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole Impurity; Lansoprazole Sulfoxide Impurity; (RS)-Lansoprazole Sulfoxide; AGN 190935 Impurity
EINECS	Contact for details

Quality Control

Our Lansoprazole Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with every shipment, containing batch-specific data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This product is light-sensitive and should be handled accordingly to maintain stability.

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 impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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