- Overview
- Our Services
- Method Development
- Method Validation
- Choose Us
Overview
Analytical method development and validation are essential processes in pharmaceutical development program to ensure the accuracy, reliability, and robustness of analytical procedures used for testing drug substances and products. Our company provides customers with full-stage analytical method development and validation services based on the requirements of ICH and different national pharmacopoeias.
Our Services
- Development and validation of a method for quantitative determination of genotoxic impurities
- Development and validation of a method for the determination of heavy metal impurities
- Development and validation of a method for the determination of residual solvents
- Development and validation of solubility determination method
- Development and validation of a method for the determination of contents and/or related substances
- Experimental design in method development, process report, validation method and validation report
Analytical Method Development Service Process
a. Project Initiation
- Define project scope, objectives, and requirements in consultation with the client.
- Identify key parameters such as analytes of interest, sample matrix, detection limits, and regulatory standards.
b. Literature Review and Preliminary Research
- Conduct a thorough literature review to identify existing methodologies and relevant scientific literature.
- Perform preliminary experiments and feasibility studies to explore potential analytical techniques and approaches.
c. Experimental Design
- Design experimental protocols and procedures tailored to the specific requirements of the project.
- Determine analytical techniques, instrumentation, and reagents needed for method development.
d. Optimization and Testing
- Systematically optimize experimental conditions such as temperature, mobile phase composition, and chromatographic parameters.
- Perform method testing using standard samples or synthetic mixtures to assess method performance and reliability.
e. Data Analysis and Interpretation
- Analyze experimental data to evaluate method performance metrics such as selectivity, sensitivity, accuracy, precision, linearity, and robustness.
- Interpret the results and identify potential directions for further optimization or refinement.
f. Documentation and Reporting
- Document experimental procedures, optimization steps, and results obtained during method development.
- Prepare a comprehensive report summarizing the methodology development process, including key findings, challenges encountered, and recommendations for further refinement.
Analytical Method Validation Service Process
a. Protocol Development
- Develop a validation protocol, acceptance criteria, experimental procedures, and validation parameters.
- Validation parameters include specificity, accuracy, precision, linearity, limit of detection (LOD), limit of quantitation (LOQ), robustness, etc.
b. Execution of Validation Experiments
- Perform validation experiments according to the predefined protocol using standardized procedures.
- Execute validation tests using representative samples and reference standards under controlled conditions.
c. Data Collection and Analysis
- Collect experimental data and analyze results to evaluate the performance of the analytical method.
- Calculate validation parameters such as recovery, repeatability, intermediate precision, correlation coefficients, and detection limits.
d. Assessment of Compliance
- Compare validation results against predetermined acceptance criteria and regulatory guidelines (e.g., ICH, pharmacopeial standards).
- Determine whether the analytical method meets the required performance characteristics for its intended application.
e. Documentation and Reporting
- Document validation procedures, experimental data, and results obtained during validation studies.
- Prepare a validation report summarizing the validation process, including a detailed discussion of validation parameters, compliance assessment, and conclusions.
f. Regulatory Submission (if applicable)
- Prepare documentation required for regulatory submissions, including validation reports, method protocols, and relevant supporting data.
- Submit validation documentation to regulatory authorities as part of the drug development and registration process.
Choose Us
Our company's analytical method development and validation services provide clients with comprehensive and reliable solutions to ensure pharmaceutical quality and compliance. If you are interested in our services, welcome to consult us.