Description

Ticagrelor Impurity 153 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Ticagrelor, a critical antiplatelet medication. This impurity is essential for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ticagrelor Impurity 153 in active pharmaceutical ingredient (API) and finished drug product batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Critical for developing, optimizing, and validating chromatographic methods to monitor this specific impurity.
• Stability Studies & Forced Degradation: Used to track the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control & Batch Release Testing: A key component in the routine QC testing protocol to ensure every batch of Ticagrelor API meets stringent purity specifications as per ICH guidelines.
• Regulatory Submissions: Provides necessary data and reference material for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Ticagrelor.

Basic Information

Product Name	Ticagrelor Impurity 153
CAS No.	1643413-83-5
Molecular Formula	C23H28F2N6O4S
Molecular Weight	522.57 g/mol
Synonyms	(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; Ticagrelor Related Compound 153; Ticagrelor EP Impurity J; Ticagrelor USP Impurity; AZD6140 Impurity 153
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 153 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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