Description

Ticagrelor Related Compound 68 Oxalate is a high-purity chemical reference standard, specifically identified as an impurity or degradation product of the antiplatelet drug Ticagrelor. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, stability studies, and quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for ensuring drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of Ticagrelor impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor related substances.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Ticagrelor and to establish appropriate shelf-life and storage conditions.
• Quality Control and Batch Release Testing: A critical component in the QC workflow to ensure that Ticagrelor batches meet the purity specifications outlined in pharmacopeias (USP, EP).
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling.
• Research on Drug Metabolism and Pharmacokinetics (DMPK): Can be utilized in studies investigating the metabolic fate and pharmacokinetic profile of Ticagrelor and its related compounds.

Basic Information

Product Name	Ticagrelor Related Compound 68 Oxalate
CAS No.	2165799-36-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 68 Oxalate; Ticagrelor Related Substance 68 Oxalate; Ticagrelor Oxalate Impurity 68; (1R,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 Oxalate; AZD6140 Related Compound 68 Oxalate; Brilinta Impurity 68 Oxalate
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 68 Oxalate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance profiling, and structural confirmation (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to a primary reference standard where applicable.

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. The product is light-sensitive (store away from light). Keep the container tightly sealed in a dry and well-ventilated place.

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 impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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