Description

Teneligliptin Impurity 11 is a specified impurity of the antidiabetic drug Teneligliptin, identified by the CAS number 2131105-24-1. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical characterization and quality control of Teneligliptin active pharmaceutical ingredients (APIs) and finished dosage forms. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as ICH guidelines.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Teneligliptin Impurity 11 in drug substances and products.
• Essential for method development and validation of analytical procedures (e.g., HPLC, UPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and impurity profiling to monitor degradation pathways of Teneligliptin.
• Used in regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and control strategies as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Supports research and development of Teneligliptin synthesis processes to understand and minimize impurity formation.
• Employed by contract research organizations (CROs) and testing facilities for client-specific analytical projects.

Basic Information

Product Name	Teneligliptin Impurity 11
CAS No.	2131105-24-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Teneligliptin Related Compound 11; (2S,4S)-4-Fluoro-1-({5-[4-(5-methyl-2-phenyl-4-oxazolyl)butyl]-1,3,4-thiadiazol-2-yl}carbonyl)-2-pyrrolidinecarbonitrile; Teneligliptin EP Impurity J; Teneligliptin USP Impurity; BRD-K77977716-001-11-1; UNII-9J3S9Q3F6R; Teneligliptin Process Impurity
EINECS	Contact for details

Quality Control

Our Teneligliptin Impurity 11 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for use as a pharmaceutical reference material. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, typically determined by advanced techniques like HPLC and LC-MS. Quality is assured in compliance with relevant ICH guidelines and internal specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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