Description

Ticagrelor Related Compound 94 Hcl is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the antiplatelet drug Ticagrelor by serving as a known impurity or degradation product for analytical method validation. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug substance characterization and quality control processes.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ticagrelor active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, calibrating, and validating chromatographic methods to ensure accuracy and regulatory compliance.
• Stability Studies: Employed to monitor the formation of degradation products in Ticagrelor formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) Testing: Essential for routine batch release testing in GMP environments to confirm that impurity levels are within specified limits (ICH guidelines).
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA) to demonstrate comprehensive impurity control.
• Research and Development: Used in metabolic and pharmacokinetic studies to understand the drug's behavior and potential related substances in biological systems.

Basic Information

Product Name	Ticagrelor Related Compound 94 Hcl
CAS No.	1643378-59-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ticagrelor Impurity 94 Hydrochloride; Ticagrelor Related Substance 94 HCl; Ticagrelor EP Impurity HCL; Ticagrelor USP Related Compound 94; (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 hydrochloride; AZD6140 Related Compound 94 HCl; Brilinta Related Compound 94 HCl
EINECS	Contact for details

Quality Control

Our Ticagrelor Related Compound 94 Hcl is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines (USP, EP).

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. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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