Expertise, flexibility and capacity to take care of your analytical requirements.
At Douglas, our analytical development experts are here to help you develop and test methods to successfully bring your product to the clinical stage and beyond.
We can support in a number of areas including:
API and Pre-formulation Characterisation
- Differential scanning calorimetry
- X-ray powder diffraction
- Infrared spectroscopy
- Particle size analysis
- Particle physical properties
- Scanning electron microscopy
Raw Ingredient testing
- Description
- Identification (IR, XRPD, UV, HPLC)
- Specific Optical Rotation
- Colour and clarity of solution (Ph. Eur.)
- Assay (HPLC)
- Organic Impurities (HPLC)
- Residual Solvents
- Water Content (KF)
- Heavy Metals (ICP-OES)
- Residue on Ignition (Ph.Eur)
- Particle Size Distribution (Laser Diffraction)
- Loss on drying
- Microbial enumeration (Ph.Eur)
- Micro Method Suitability
Finished Product Testing
At Douglas, we utilise 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 Harmonisation (ICH) requirements, or any globally relevant regulatory guidance, whenever appropriate.
We’ll work with the customer to set Finished Product specifications and release test to those specifications accordingly.
Method Validation
Method Validation is the process of demonstrating that an analytical method is suitable for its intended purpose. It is a critical step to ensure that the developed analytical method is suitable for its intended use. The validation process also includes documenting the validation protocols, results, and conclusions in a comprehensive validation report. This serves as a crucial document for regulatory submissions and ensures traceability and accountability of the analytical method.
ICH Stability Testing
We follow the ICH stability guidelines to support shelf-life claims and to guide formulation development.
Forced degradation studies play a significant role in understanding the degradation pathways, impurity profiles, and stability characteristics of drug substances and drug products.
Impurity Identification
The Douglas team has extensive experience and a wide range of analytical equipment to conduct successful impurity identification for drug substances and drug products.
Our impurity identification services include:
- Mass spectrometry (MS) and ultra-performance liquid chromatography (UHPLC) methods
- Isolation of the impurity using preparative high-performance liquid chromatography (HPLC)
Equipment
Some of the equipment we specialise in at Douglas:
- U/HPLC
- Gas chromatography
- Karl Fischer
- Mass Spec
- UV/Vis Spectroscopy
- Dissolution apparatus
- FTIR