Services


Analytical Services:

HDH Pharma utilizes a step-wise approach for analytical testing. The activities completed are appropriate to the phase of the drug development. From discovery candidates to clinical trial materials to regulatory submissions to post-approval studies, we offer our partners an extensive array of small and large molecule analytical capabilities. . 

Our focused studies provide a range of benefits that can enhance your final outcome:

  1. Extensive experience in method development, optimization, qualification and validation
  2. Custom designed for your drug substance and/or drug product

Method Development
 
  1. Evaluate methodology based on the development phase.
  2. Optimize the reagent selection, the sample introduction, and the sample size.
  3. Approximate, instantaneous solubility study to assess possible diluents and mobile phases.
  4. UV spectrum of the API to assess detection wavelength.
  5. Scouting run to determine column chemistries.
  6. Pre-Validation Exercise - mini linearity, LOD/LOQ, specificity check before committing to formal validation.

Method Qualification/Validation
 
  1. Accuracy, Linearity, Repeatability, Intermediate precision and System precision.
  2. Specificity - including limited forced degradation studies for stability indication chromatography methods at early phases and full forced degradation studies at late phases (acidic, basic, oxidative, thermal and photolytic stress conditions).2
  3. Limits of detection and quantitation.
  4. Solution stability.
  5. Peak Purity by Photodiode Array (PDA) for stability indication chromatography methods Additional critical aspects of the assay will be included.

 
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