Test Services

Method Development

DYNALABS has a department dedicated to performing method development and method validation services. Our scientists have years of experience working on stability indicating methods, residual solvent methods, and dissolution methods. We have our own protocols that comply with FDA guidelines or we can follow client-supplied protocols. Our protocols are flexible enough to be custom designed to meet client specific requirements.

We offer method development and validation services using a wide range of technologies including: HPLC, GC, TLC, ELISA, FTIR, UV-VIS Spectrophotometry. We have extensive experience in HPLC method development, HPLC validation, GC method development and GC validation. We use these analytical techniques to develop and validate methods for API’s, intermediates, raw materials and finished products.

We provide a report at the conclusion of each project. Included within this report is the analytical method itself which is written in a step-by-step format.

Our protocol includes the following parameters:

• Precision
  
• Limit of detection (LOD)
  
• Limit of quantitation (LOQ)
  
• Accuracy
  
• Linearity
  
• Range
  
• Specificity
  
• Robustness
  
• System Suitability
  
• Ruggedness
  
• Standard & Custom Forged Degradation
  
• Stability of Standard and Sample Solutions

DYNALABS brings years of experience performing all types of analytical testing on many drug substances and drug. We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. We are FDA and DEA registered, cGMP compliant