Description

Ticagrelor Related Compound 27 Oxalate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity or degradation product of Ticagrelor, a key antiplatelet medication, making it essential for ensuring drug safety and efficacy. It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and rigorous quality control testing. The availability of this well-characterized standard is fundamental for meeting stringent regulatory requirements in drug substance and drug product analysis.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ticagrelor Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating stability-indicating HPLC or UPLC methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency and purity specifications are met.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Pharmacopoeial Testing: Supports testing procedures aligned with standards from USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other pharmacopoeias.

Basic Information

Item	Detail
Product Name	Ticagrelor Related Compound 27 Oxalate
CAS No.	1816939-47-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 27 Oxalate; Ticagrelor Oxalate Related Compound 27; Ticagrelor Degradant 27 Oxalate; Ticagrelor Oxalate Impurity 27; Ticagrelor EP Impurity O Oxalate; Ticagrelor Related Substance 27 Oxalate; (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 Oxalate
EINECS	Contact for details

Quality Control

Every batch of Ticagrelor Related Compound 27 Oxalate is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F), in a dry environment. For long-term storage, consider storing at 2°C to 8°C. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability.

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%
Assay (by HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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