Description

Ticagrelor Impurity 96 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Ticagrelor, a key antiplatelet medication. It serves as an essential benchmark for analytical method development, validation, and impurity profiling. Pharmaceutical manufacturers and analytical laboratories require this standard to ensure drug safety, efficacy, and adherence to strict pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, and LC-MS methods to monitor impurity levels during manufacturing.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Ticagrelor meets specified purity thresholds as per ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf-life.
• Process Chemistry Research: Aids chemists in understanding and optimizing the Ticagrelor synthesis pathway to minimize impurity formation.

Basic Information

Product Name	Ticagrelor Impurity 96
CAS No.	1643413-84-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 96; Ticagrelor Impurity 96; Ticagrelor EP Impurity 96; Ticagrelor USP Impurity 96; (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 (IUPAC-based); AZD6140 Impurity 96; Brilinta Impurity 96
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 96 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity characterization.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider conditions recommended for pharmaceutical reference standards.

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)	Total impurities ≤ 5.0% Any single 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.