NABL Accredited · ICH Q2(R1) Compliant

Analytical Method Validation Services India | ICH Q2(R1) | NABL

Analytical method development and validation services per ICH Q2(R1) from an NABL-accredited laboratory in India.

Analytical method validation is the regulatory requirement that every analytical procedure used for pharmaceutical testing must be demonstrated as fit for purpose. Auriga Research provides end-to-end method development and validation services compliant with ICH Q2(R1), ensuring your analytical methods meet the specificity, linearity, accuracy, precision, and robustness standards required by CDSCO, FDA, EMA, and other regulatory agencies.

Our method development process begins with systematic technique selection and feasibility assessment, followed by column and mobile phase screening for chromatographic methods, optimisation of separation conditions, and forced degradation studies to establish stability-indicating capability. Once the method is optimised, we execute full ICH Q2(R1) validation covering all required parameters with detailed protocol, raw data, and validation report suitable for inclusion in CTD Module 3.

We also provide method transfer verification, partial validation for compendial method adaptations, and cross-validation between analytical techniques. Our experienced analytical team has validated methods across HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer, ICP-OES, ICP-MS, and microbiological assay platforms.

Method Validation Parameters (ICH Q2(R1))

  • Specificity — forced degradation under acid, base, oxidative, thermal, and photolytic stress
  • Linearity and range — correlation coefficient, y-intercept, and residual analysis
  • Accuracy — recovery studies at 80%, 100%, and 120% of target concentration
  • Precision — repeatability (intra-day) and intermediate precision (inter-day, inter-analyst)
  • Limit of detection (LOD) and limit of quantitation (LOQ)
  • Robustness — deliberate variation of critical method parameters
  • System suitability criteria and solution stability
  • Method transfer and cross-site verification protocols

Turnaround Time

Method Development: 2-4 weeks
Full ICH Q2(R1) Validation: 3-4 weeks
Combined Dev + Validation: 6-8 weeks
Method Transfer Verification: 2-3 weeks

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Frequently Asked Questions — Analytical Method Validation

What is analytical method validation per ICH Q2(R1)?
Analytical method validation per ICH Q2(R1) is the process of demonstrating that an analytical procedure is suitable for its intended purpose. The guideline requires evaluation of specificity, linearity, range, accuracy, precision (repeatability and intermediate precision), detection limit, quantitation limit, and robustness. Each parameter has defined acceptance criteria that must be met before the method can be used for routine testing, stability studies, or regulatory submissions.
What analytical techniques does Auriga validate methods for?
Auriga Research develops and validates methods across all major pharmaceutical analytical techniques including HPLC, UPLC, GC, UV-Vis spectrophotometry, dissolution testing, Karl Fischer titration, ICP-OES, ICP-MS, and microbiological assays. Our team selects the appropriate technique based on the analyte, matrix, and regulatory requirements, then develops and validates the method to ICH Q2(R1) standards.
What is the difference between method development and method validation?
Method development is the process of designing and optimising an analytical procedure — selecting the technique, column, mobile phase, detection parameters, and sample preparation. Method validation is the subsequent process of proving that the developed method performs as intended, meeting predefined acceptance criteria for specificity, linearity, accuracy, precision, and robustness. Development precedes validation, and both are required for regulatory acceptance.
What is the typical turnaround time for method development and validation?
Method development at Auriga Research typically requires 2-4 weeks depending on analyte complexity and matrix. Full ICH Q2(R1) method validation requires an additional 3-4 weeks. Combined method development and validation projects are completed within 6-8 weeks. Partial validation or method transfer verification can be completed within 2-3 weeks.

Need Analytical Method Development or Validation?

ICH Q2(R1) compliant method validation from an NABL-accredited laboratory. Complete validation reports for regulatory submissions.

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