918博天堂

1. Pharmaceutical Analytical Method Development and Standard Establishment Platform

As an authoritative municipal drug control institute in the research of drug specifications and advanced drug inspection and testing, the Center has established a comprehensive platform for pharmaceutical analytical method development, validation, and transfer. Our capabilities include physicochemical, microbiological, and bacterial endotoxin testing for chemical drugs. We support the establishment of quality standards across the entire drug lifecycle - from R&D through post-market stages.

2.Drug Stability Research Platform

Drug stability studies aim to evaluate the change pattern of drug quality over time and scientifically establish the shelf-life and storage requirements. Our platform offers end-to-end support, including study design, execution, and analysis for the stability studies on drug substances and products (raw materials and preparations). We conduct studies related to innovative drugs, generic drugs, and changes to marketed chemical drugs. Additionally, we perform migration and adsorption tests for compatibility studies between drug products and packaging materials or containers.

3.Drug Viscosity and Rheology Testing Platform

In compliance with relevant domestic and international regulations and guidelines, the Center has established a specialized technical platform for drug viscosity and rheology testing. We have extensive experience in method development, validation, measurement, and evaluation. Capabilities include capabilities of viscosity measurement and method development, as well as the ability to conduct rheological property research and rheological equivalence evaluation of generic drugs.

4.Chemical Drug Impurity Profile Research Platform

Leveraging Multidimensional analytical techniques, we provide impurity structural identification and origin investigation, developing impurity control strategies with scientifically established acceptance criteria. It researches complementary detection technologies, such as combining positive-phase and reversed-phase systems, and applying multi-dimensional liquid chromatography-mass spectrometry (LC-MS) technology, ion chromatography analysis technology, capillary electrophoresis technology, etc., to carry out impurity profile research.

5.Chemical Reference Standard Preparation and Qualification Platform

The center is equipped to qualify chemical reference standards using both the Mass Balance Method and the Value Assignment Method. We also employ preparative liquid chromatography technology for the development of working chemical reference standards, ensuring full traceability and metrological reliability.

6.Oral Solid Dosage Form Dissolution Profile Characterization Platform

In compliance with major pharmacopoeias such as Chinese Pharmacopoeia (ChP), United States Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP), and relevant guidelines from NMPA, FDA, and EMA, the center performs the dissolution profile of oral solid dosage forms, dedicated to providing high-quality, efficient, and customized professional services, and facilitating the R&D and market launch for generic and innovative drugs.

7.Pharmaceutical Element Analysis Platform

Leveraging diverse elemental analysis instrumentation and adhering to ICH Q3D and international/national Pharmacopeial guidelines, the center has established a comprehensive elemental analysis and research system. Our focus encompasses quantification of elemental content, identification of impurities, and investigation of process-related elemental impurities in drug substances, excipients, and finished products.

8.Drug Particle Characterization Platform

The particle size and characterization of drug substances, excipients, and dosage forms significantly influence critical quality attributes, including dissolution performance, bioavailability, content uniformity, and stability. The center offers comprehensive particle size analysis services using microscopy, light scattering, and Coulter counter techniques for the development, validation. We support method development, validation, and testing for drug substances, excipients, and preparations.

9.Rapid Microbiological Method（RMM）Platform

In compliance with the Chinese Pharmacopoeia (ChP), European Pharmacopoeia (EP), and United States Pharmacopeia (USP), the Center employs a fully automated rapid microbiological detection system for sterility testing. This platform supports rapid sterility assessment and timely release strategies for pharmaceuticals, innovative biologics, and related products, accelerating time-to-market while ensuring product safety.

10.Microbial Identification Platform

The Center utilizes a comprehensive suite of advanced techniques, including biochemical, microscopic, protein-based (MALDI-TOF MS), and nucleic acid-based (DNA sequencing) identification, to accurately and rapidly identify reference strains and environmental isolates from pharmaceutical settings; We also support manufacturers in establishing proprietary strain libraries and constructing detailed microbial contamination maps, enhancing contamination control strategies and ensuring product safety.

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