Description

Ticagrelor Impurity 68 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Ticagrelor. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on active pharmaceutical ingredient (API) characterization and impurity profiling.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ticagrelor Impurity 68 in drug substance and drug product.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and LC-MS, for impurity detection in Ticagrelor API.
• Stability Studies: Used to monitor the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity data for drug approval dossiers.
• Quality Control Testing: Serves as a system suitability standard and for routine batch release testing to ensure Ticagrelor meets stringent purity specifications.
• Process Chemistry Research: Aids in understanding and optimizing the Ticagrelor synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Ticagrelor Impurity 68
CAS No.	1643378-46-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 68; Ticagrelor Impurity D; Ticagrelor EP Impurity D; (1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino]-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol; AZD6140 Impurity 68; 1643378-46-4
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 68 is manufactured and tested under strict quality systems. Each batch is characterized using advanced analytical techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing the results for all specified tests. The material is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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