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:
- Extensive experience in method development, optimization, qualification and validation
- Custom designed for your drug substance and/or drug product
- Evaluate methodology based on the development phase.
- Optimize the reagent selection, the sample introduction, and the sample size.
- Approximate, instantaneous solubility study to assess possible diluents and mobile phases.
- UV spectrum of the API to assess detection wavelength.
- Scouting run to determine column chemistries.
- Pre-Validation Exercise - mini linearity, LOD/LOQ, specificity check before committing to formal validation.
- Accuracy, Linearity, Repeatability, Intermediate precision and System precision.
- 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
- Limits of detection and quantitation.
- Solution stability.
- Peak Purity by Photodiode Array (PDA) for stability indication chromatography methods Additional critical aspects of the assay will be included.