Analytical Method Development and Validation Testing

Analytical Method Development and Validation Testing

Fig.1 Analytical Method Development and Validation Testing

Analytical method development and validation are key elements of any drug development program. Protheragen-ING Lab offers comprehensive analytical method development and validation testing services to assist pharmaceutical, biotechnology, and other industries in ensuring the quality, safety, and efficacy of their products.

Using state-of-the-art instrumentation, advanced technologies and industry-recognized guidelines, our experienced team of scientists develops and validates reliable analytical methods tailored to your specific needs to meet the objectives required at every stage of drug development. We ensure that all analytical methods are effectively developed and validated for a wide range of APIs, drug compounds, excipients, and finished products, reducing the cost, complexity, and overall timeline of development.

Analytical method development

Analytical method development is the process of selecting and optimizing analytical methods to measure specific properties of an API or drug product. The process provides important information about the purity, identity, physical properties and potency of a drug product, including its bioavailability and stability. Key aspects of our method development process include:

  • Method Selection and Optimization: We evaluate different analytical techniques and determine the most suitable method based on the physicochemical properties of the target analyte, sample matrix, detection limits, and other relevant factors.
  • Method Feasibility Studies: We conduct preliminary experiments to assess the applicability and performance of potential methods, ensuring their suitability for further development.
  • Method Development and Optimization: Using advanced instrumentation and scientific expertise, we optimize parameters such as separation conditions, mobile phase composition, detection wavelength, sample preparation techniques, and more to achieve accurate and precise results.
  • Forced Degradation Studies: We perform stress testing on drug substances or products to identify degradation pathways and select appropriate stability-indicating methods for quality control purposes.

Analytical method validation

Method validation is the process of demonstrating that an analytical method is suitable for its intended use and is capable of producing reliable and consistent results over time. Protheragen-ING Lab aims to provide scientific evidence of the reliability, accuracy and robustness of the analytical methods developed.

We ensure that a validation program is developed that is stage-appropriate for your objectives. Our standard operating procedures (SOPs) for validation methods are modeled according to the guidelines in USP<1225>.

Our validation process includes the following key elements:

  • Specificity and Selectivity: We assess the method's ability to differentiate the analyte from potential impurities, degradation products, and other matrix components, ensuring reliable quantification.
  • Precision and Accuracy: We evaluate the repeatability, intermediate precision, and accuracy of the method by analyzing multiple samples under various conditions to ensure consistent and precise results.
  • Linearity and Range: We determine the linearity, range, and limits of detection and quantification of the method to establish its suitability for a specific analytical purpose.
  • Robustness and System Suitability: We evaluate the method's robustness by testing its performance under different conditions such as changes in pH, temperature, and flow rate. System suitability parameters are also determined to ensure consistent system performance.
  • Stability Studies: We conduct stability studies to assess the method's performance over time, including evaluation of analyte stability under different storage and sample preparation conditions.

Depending on the property being analyzed, we use state-of-the-art instruments such as HPLC, LC-MS, HRMS, MS/MS, GC-FID /MS, NMR, enzyme markers, etc.

Fig.2 Analytical method validation

Why Choose Us?

  • Expertise.
  • State-of-the-Art Facilities.
  • Regulatory Compliance.
  • Customized Solutions.
  • Timely Delivery.
  • Confidentiality.

If you require analytical method development and validation testing services, please contact us. We are happy to discuss your specific requirements and provide customized solutions to meet your analytical needs.