Description

Ticagrelor Impurity 24 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the antiplatelet drug Ticagrelor. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, manufacturing, and regulatory affairs.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ticagrelor Impurity 24 in active pharmaceutical ingredients (API) and finished drug products.
• Method Development and Validation: Critical for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor impurity profiles and ensure Ticagrelor API meets stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and demonstrate comprehensive control of the drug substance.
• Research and Development: Supports process chemistry research aimed at understanding impurity formation pathways and optimizing synthesis to minimize its presence.

Basic Information

Product Name	Ticagrelor Impurity 24
CAS No.	1482484-92-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(1R,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; Ticagrelor Related Compound 24; Ticagrelor Impurity RRT 1.24; AZD6140 Impurity 24; Brilinta Impurity 24
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 24 is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as HPLC, LC-MS, and NMR for full structural confirmation and purity assessment. We adhere to relevant guidelines for impurity standards, supporting compliance with ICH, USP, and EP requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C in a dry environment. For long-term storage, consider storing desiccated under inert atmosphere. Allow the vial to equilibrate to room temperature before opening to prevent moisture condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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