Description

Ticagrelor Impurity 18 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiplatelet drug Ticagrelor by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality assurance testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines and regulatory submissions.

Application

• Primary use as a certified reference standard for the identification and quantification of Ticagrelor Impurity 18 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Ticagrelor and related substances.
• Essential for impurity profiling and control during Ticagrelor API manufacturing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Used in stability studies to monitor the formation of degradation products under various stress conditions.
• Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and submission packages.
• Valuable for pharmaceutical research to understand the degradation pathways and chemical behavior of Ticagrelor.
• Employed in quality control laboratories for routine release testing and in-process checks of Ticagrelor batches.

Basic Information

Product Name	Ticagrelor Impurity 18
CAS No.	220352-32-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 18; Ticagrelor Impurity O; Ticagrelor EP Impurity G; Ticagrelor USP Impurity; (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 18
EINECS	Contact for details

Quality Control

Our Ticagrelor Impurity 18 is manufactured and tested under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial expectations (e.g., USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all specified tests, including chromatographic purity and structural confirmation.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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