Description

Maihuatini Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a known impurity marker. It is primarily utilized by researchers and quality control laboratories in the pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling studies. The compound is supplied with full analytical characterization to support rigorous scientific work.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Maihuatini drug substances and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products under various stress conditions, supporting drug shelf-life determination.
• Regulatory Compliance & Submissions: Essential for generating data to meet the stringent requirements of regulatory bodies like the FDA, EMA, and ICH guidelines.
• Chemical Research: Used in academic and industrial research to study the metabolism, degradation pathways, and chemical behavior of related pharmaceutical compounds.
• Quality Assurance/Quality Control (QA/QC): Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Maihuatini Impurity 1
CAS No.	574738-64-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Maihuatini Related Compound A; Maihuatini Impurity A; Maihuatini EP Impurity A; Maihuatini USP Impurity; Maihuatini Process Impurity; (Chemical name based on structure - Contact for details); Maihuatini Degradant
EINECS	Contact for details

Quality Control

Every batch of Maihuatini Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced analytical techniques, and a detailed Certificate of Analysis (COA) providing purity, identity, and impurity data is available upon request. Production can be aligned with cGMP guidelines for pharmaceutical reference standard applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (typically 15-25°C) in a dry environment. For long-term storage under inert atmosphere, please contact our technical team for specific recommendations.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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