Quality Analysis Research Services

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Wuhan Hiteck Biological Pharma Co., Ltd. Analytical Laboratory adopts lean 5S management, equipped with state-of-the-art facilities, advanced support software, and a standardized GLP quality system. It operates with strict compliance and confidentiality, offering specialized analytical services such as analytical method development and quality research for small molecule chemical drugs.

Two major service platforms—Analytical Methodology Research

A comprehensive method development and screening platform, featuring 8 HPLC multi-channel screening systems, 2 complete analytical method development kits, and a range of chromatographic columns including reverse-phase columns (C18/AQ/C8/PFP/HILIC), gas chromatography columns (FFAP/HP/WAX/624/CP), and chiral columns (AD/OD/OJ/AS/OX/IA/IC/IG), HPLC-UV detector, HPLC-electrospray (CAD) detector, GC-FID detector, GC-ECD detector, LCMS, etc., network-based data processing system, regular data backup, account hierarchical management, audit trail, timely and traceable records, capable of developing rapid and highly accurate analytical methods, compliant with ICH regulations, and providing analytical method validation services.

Two major service platforms—Quality Research Platform

With the support of experienced chemical synthesis technicians specializing in IND/NDA/ANDA submissions, we conduct research on the generation, derivation, and transfer of impurities, as well as the preparation of impurities. In accordance with ICH regulations, we perform studies on general impurities, residual solvents, structural confirmation, impurity standardization, and testing and release. We collaborate with stable and professional partner institutions to conduct research on elemental impurities and basic toxic impurities, providing comprehensive and reliable quality research services.

Technical background

The ICH Q8 guideline states that the concept of quality by design can be applied to various aspects of analytical method development, evaluation, transfer, and validation. Jacky Musters defines analytical quality by design (AQbD) as a systematic research approach based on predefined analytical method objectives, continuously enhancing scientific understanding of analytical method performance, improving its reliability, and conducting ongoing validation and improvement throughout the entire method lifecycle.

The AQbD methodology comprises several key elements, including analytical method objectives (ATP), risk assessment, critical method attributes, critical method parameters, design space, and control strategies, which together form the analytical method development steps and strategies.

References:

1. Applying QbD principles to develop a generic UHPLC method which facilitates continual mprovement and innovation throughout the product lifecycle for a commercial API.

2. Research progress on the application of Quality by Design (QbD) in the development of drug analysis methods.

World Environment Day 2025

Hiray Pharma(Jingmen) participated in the 7th Organic Chemistry Sakura Forum at Wuhan University.

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