最新色情影片

Skip to Main ContentSkip to FooterSkip to Search
Main menu
Regional Sites
  1. Home
  2.  » 
  3. Oral Dose
  4.  » 
  5. Oral Dose Analytical Solutions
  6.  » Methods Development & Validation

Methods Development & Validation

EXPERTLY MEETING THE SPECIFICITY DEMANDS OF ANALYTICAL ASSAYS

最新色情影片 utilizes a step-wise approach for analytical testing. The activities completed are appropriate to the phase of the drug development. Analytical activities will be completed with reference to International Conference on Harmonization (ICH) requirements, or any globally relevant regulatory guidance, whenever appropriate.

Back to top

CATALENT BENEFITS

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 

Back to top

METHOD EVALUATION

  • 最新色情影片 will demonstrate that system suitability requirements are met using standards and/or 1鈥2 samples (when available).
  • 最新色情影片 will perform sufficient evaluation to establish confidence that required method parameters can be met.
  • It is assumed that these methods are robust and will require minimal effort to establish at 最新色情影片 (no development or adjusting of method parameters).
  • Compendial methods must be taken from a recognized compendium such as the USP/NF, Ph. Eur., and JP. 最新色情影片 assumes the methods do not require validation as they will be run as per the compendia.

Back to top

METHOD TRANSFER

  • 最新色情影片 requires documentation of validation for the method/s to be transferred.
  • 最新色情影片 will provide a transfer protocol (in standard format) for Client approval prior to initiating the transfer study.  Results generated by 最新色情影片 will be compared with those of the transferring facility.
  • 最新色情影片 will demonstrate that the method is operational by generating data (e.g., spectra, chromatograms, etc.) using standards and/or 1鈥2 samples, and demonstrating that system suitability requirements are met.
  • It is assumed that these methods are robust and will require minimal effort to establish at 最新色情影片 (no development or adjustments of method parameters)

Back to top

METHOD DEVELOPMENT

  • 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
  • Informal forced degradation study to select one marker solution for method development (thermal and photolytic stress conditions)
  • Scouting run to determine column chemistries
  • Sensitivity evaluation
  • Pre-Validation Exercise – mini linearity, LOD/LOQ, specificity check before committing to formal validation
  • Assess stability in preferred media in 37 C for duration of dissolution tests
  • Optimize medium, paddle/basket speed and sampling times for final formulation for dissolution tests

Back to top

METHOD QUALIFICATION/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)
  • Limits of detection and quantitation
  • Solution stability
  • Peak Purity by Photodiode Array (PDA) for stability indication chromatography methods
  • Robustness assessments (assessed by making small deliberate variations in method parameters and measuring the effect)
  • Additional critical aspects of the assay will be included (as necessary)

Back to top

FACILITIES

By using this website you understand and accept that 最新色情影片 tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our聽听触听听触听Cookies Settings.