Description

Ticagrelor Impurity 81 (L-Tartaric Acid) is a high-purity reference standard specifically used for the analytical control and quality assurance of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for research and development, method validation, and routine quality control testing in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Ticagrelor Impurity 81 in active pharmaceutical ingredients (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Ticagrelor.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filings: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data required for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed to track the formation of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research on Degradation Pathways: Facilitates studies into the chemical degradation mechanisms of Ticagrelor, aiding in formulation optimization.

Basic Information

Product Name	Ticagrelor Impurity 81 (L-Tartaric Acid)
CAS No.	2376278-68-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Related Compound 81; Ticagrelor Impurity 81 L-Tartrate; (1S,2S)-1,2-Dihydroxybutanedioic acid impurity of Ticagrelor; L-Tartaric Acid derivative of Ticagrelor Impurity; Ticagrelor EP Impurity L; Ticagrelor USP Impurity; Ticagrelor Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Impurity 81 (L-Tartaric Acid) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

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 dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccants or a nitrogen atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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