Description

Ticagrelor Impurity 72 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 active pharmaceutical ingredient (API) 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 and manufacturing, particularly for those involved in method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Ticagrelor.
• Method Development and Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities in Ticagrelor API and finished dosage forms.
• Quality Control & Batch Release: Used in routine QC testing to ensure Ticagrelor batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity profiles.
• Stability Studies: Employed to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during Ticagrelor synthesis.

Basic Information

Item	Detail
Product Name	Ticagrelor Impurity 72
CAS No.	63755-08-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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 72; Ticagrelor Impurity C; AZD6140 Impurity 72; BRILINTA Impurity 72
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 72 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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