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Advanced Analytical Chemistry & E&L Consulting Solutions

General Analytical Chemistry Capabilities

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The workstation on the left features advanced computer monitors displaying complex chromatographic data (HPLC/GC peaks). SMZY delivers core analytical solutions including:

 

  • Method Development & Validation: Custom assay design, purity testing, and quantitative method development following ICH Q2(R1) guidelines.

     

  • Routine Quality Control: Mass spectrometry (MS), gas chromatography (GC), and liquid chromatography (LC) analysis for raw materials and finished products.

     

  • Structure Elucidation: Unknown impurity identification using high-resolution mass spectrometry and analytical spectral evaluation.

     

Extractables and Leachables (E&L) Expertise

 

The right side of the laboratory showcases specialized instrumentation, including GC-MS/LC-MS systems, alongside visual workflow documentation for Extractables and Leachables testing. SMZY provides end-to-end E&L advisory:

 

PhaseFocus AreaAnalytical Approach

1. Controlled Extraction StudiesMaterials CharacterizationAggressive solvent extraction to identify potential organic and inorganic leachables.

2. Simulation & ScreeningRisk AssessmentEvaluation of container closure systems (CCS), single-use systems (SUS), and drug delivery devices under real-world storage conditions.

3. Target Method ValidationSemi-Quantification & SafetyToxicological evaluation, Analytical Evaluation Threshold (AET) determination, and trace leachable monitoring in final drug formulations.

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