More Precision, Less Turnaround Time


Analytical Method Development (AMD) and Analytical Method Validation (AMV)

OTH is proficient in carrying out essential and complex method development and method validation studies for drugs, excipients, impurities, residual solvents, powdered samples, dissolution samples, microbiological tests, bacterial endotoxins, trace metals, heavy metals and catalyst residues. The method development and validation studies are performed in accordance with ICH guidelines and systematic procedures by the experienced scientists of OTH.

The parameters evaluated for the method development and validation include:

  • Linearity
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Specificity (including stability of solutions)
  • Precision (method, intermediate and system)
  • Accuracy (recoveries)
  • Robustness
  • Forced degradation
  • System Suitability
  • Specificity including forced degradation
  • Stability of solution
  • Filter compatibility
  • Linearity and range
  • Precision (System, Method and Intermediate)

The procedure followed for Analytical Method Validation :

  • Designing Method Validation Protocol
  • Getting approval
  • Initiating the analysis
  • Sharing Validation Report

Stability Studies

Stability Chambers for stability conditions continuously monitored by Automated Monitoring System with full back up power and water supplies.

  • Accelerated Stability Study : 40°C ± 2°C, 75% ± 5% RH
  • Intermediate Stability Study : 30°C ± 2°C, 65% ± 5% RH
  • Long Term Stability Study : 25°C ± 2°C, 60% ± 5% RH
  • Stability Study : 30°C ± 2°C, 75% ± 5% RH
  • Humidity cum Photo stability Study

Dissolution Profiling Studies

OTH is adept in conducting significant dissolution profiling studies for the generic pharmaceutical industry. The studies effectively help the clients with identification of formulation factors that influence bioavailability of the API and gauge quality assurance and bioequivalence.

Preservative Efficacy Testing

OTH has proven expertise and capabilities in performing Preservative Efficacy Tests (also known as Antimicrobial Efficacy Tests) for the assessment of antimicrobial preservation of pharmaceutical, cosmetic and personal care products.