Description

Pyrotinib Racemate CAS NO 1246089-97-3 is a key chemical reference standard and synthetic intermediate in advanced pharmaceutical research and development. This compound is of significant value for analytical method development, impurity profiling, and pharmacokinetic studies. It is primarily utilized by research institutions, pharmaceutical companies, and contract development and manufacturing organizations (CDMOs) engaged in the discovery and synthesis of novel therapeutic agents.

Application

• Pharmaceutical Reference Standard: Used for the qualitative and quantitative analysis of Pyrotinib and related substances in drug substances and products.
• Research & Development Intermediate: Serves as a critical building block in the synthetic pathways for developing tyrosine kinase inhibitors and other targeted therapies.
• Impurity Characterization: Essential for identifying, quantifying, and qualifying process-related impurities and degradation products in accordance with ICH guidelines.
• Bioanalytical Method Development: Employed as a standard in developing and validating HPLC, LC-MS, and other analytical methods for biological matrices.
• Metabolite Studies: Used in preclinical and clinical research to study the metabolic pathways and pharmacokinetics of active pharmaceutical ingredients.
• Quality Control Laboratories: Provides a benchmark for in-house quality control testing to ensure batch-to-batch consistency and regulatory compliance.

Basic Information

Product Name	Pyrotinib Racemate
CAS No.	1246089-97-3
Molecular Formula	C32H33ClN6O3
Molecular Weight	585.10 g/mol
Synonyms	(±)-Pyrotinib; Pyrotinib (Racemic); UNII-1S8N0J8X5H; (Rac)-Pyrotinib; 1-[[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]carbonyl]-4-(1-piperidinyl)-2(S)-piperidinecarboxylic acid ethyl ester (racemic); Irinitib Racemate; SHR1258 Racemate; Ethyl (2S)-1-({4-[(3-chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl}carbonyl)-4-piperidin-1-ylpiperidine-2-carboxylate (racemate)
EINECS	Contact for details

Quality Control

Our Pyrotinib Racemate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all test results against established specifications to ensure compliance with research-grade 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 product is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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