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 impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification during analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Ticagrelor Impurity 72 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor this specific impurity.
• Quality Control & Batch Release Testing: Used in routine QC labs to ensure Ticagrelor drug substance and product batches meet stringent purity specifications as per ICH guidelines.
• Stability Studies: Employed to track the formation and level of this impurity over time under various stress conditions to determine drug shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory agencies like the FDA and EMA.
• Research & Process Chemistry: Aids in understanding the degradation pathways and synthesis by-products of Ticagrelor, helping to refine manufacturing processes.

Basic Information

Product Name	Ticagrelor Impurity 72
CAS No.	1402150-11-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 72; Ticagrelor Impurity C; Ticagrelor EP Impurity C; (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 72
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 72 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, impurity profile, and analytical results, supporting compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown 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.