Analytical Method Development
Robust and stability-indicating methods are significant drivers to ensure product quality and ensure faster regulatory approval.
Our method development strategy involves the use of proper scientific approaches and scientific literature reviews which lead to the appropriate selection of analytical techniques for the targeted product.
Daicel Pharma Services is capable of developing phase-appropriate analytical methods from key starting materials to finished products (Drug Substances and Drug Products).
We specialize in Method Development of the following:
- Stability-indicating related substances by HPLC (including UV transparent compounds)
- Stability-indicating assay methods by HPLC (including UV transparent compounds)
- Purity by HPLC
- Residual solvents by GC/GCHS
- Enantiomeric purity by HPLC (Global leader in this area)
- Genotoxic impurity quantification at ppm and ppb level
- Screening and development of methods for elemental impurities by ICPMS, as per USP general chapter <232>, <233>, ICH Q3D
- Non-carry over studies at ppm and ppb level by LCMSMS/GCMSMS
- Residue/cleaning methods
- Quantification of ions by Ion Chromatography
- In-process control methods for intermediates
- Extractable and Leachable studies
- Peptides and Biologics
- In vitro bioequivalence studies
By following our “First Time Right” concept, we support all of our customers by developing appropriate analytical methods, without compromising on quality, and completing projects within agreed timelines.
A dedicated team can be assigned, for a particular project, based on customer requirements.
Analytical Method Validation
Method validation is one of the most crucial components in any regulatory submission.
- Our validation protocols and reports are based on globally accepted guidelines such as ICH/FDA/USP/ANVISA requirements and cover various parameters
- We are capable of validating methods to support DMF/ANDA filings
- We perform method validation as per ICH Q2 requirements, meeting 21 CFR Part 11 regulatory requirements for electronic review and electronic signatures
Efficiency and productivity are ensured by the implementation of custom field calculations and electronic signatures. The data calculations are embedded in your report to avoid manual error.
Analytical Method Transfer
We provide services for the transfer of analytical methods to customer sites with pre-approved protocols.
- Direct/Indirect method transfers
- Co-validation/Reproducibility studies