At Douglas CDMO, we offer a comprehensive suite of analytical services tailored to meet every stage of your pharmaceutical project. From raw material analysis to batch release testing, we provide thorough support for your development, manufacturing, and packaging needs.
Analytical testing
Douglas CDMO has extensive expertise in method development, technology transfer, validation and verification, cleaning validation and stability studies against regulatory guidelines for both compendial and non-compendial methods across many types of dosage forms.
API and pre-formulation characterization
We perform comprehensive analyses of both active ingredients and other components, ensuring the preservation of drug properties, effectiveness, and safety.
- X-ray powder diffraction
- Infrared spectroscopy
- Particle size analysis
- Particle physical properties
- Scanning electron microscopy
- Solubility studies
- Forced degradation
- Excipient compatibility study
Raw ingredient testing
Throughout the development and manufacturing process we undertake raw ingredient testing, to ensure raw materials meet quality standards. We review based on the following criteria:
- 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
Overview of analytical equipment
Some of the equipment we specialize in at Douglas CDMO for analysis includes:
- Liquid chromatography: high-pressure liquid chromatography (HPLC) and ultra-performance liquid chromatography (UPLC) equipped with different types of detectors such as Photo diode array (PDA), UV-visible, Fluorescence (FLR), Tunable UV (TUV).
- Gas Chromatography (GC): with flame ionization detection (FID) and headspace analysis.
- Moisture analysis (Karl Fischer).
- Single Quadrupole LC-MS covering mass range 10 – 1250 m/z Fourier- transform infrared spectroscopy (FTIR).
- Dissolution (USP apparatus 1 and 2 with autosamplers, USP apparatus 3 (Reciprocating cylinder)).
- Microscopy FTIR.
- particle size analysis (laser light scattering and light obstruction).
- Densitometer.
- Viscometer.
Impurity identification
We have extensive experience and a wide range of analytical equipment to identify and characterize impurities present in a sample.
Our impurity identification services include mass spectrometry (MS) and ultra-performance liquid chromatography (UHPLC) methods.
Batch release testing
Our comprehensive assessment ensures that your product meets quality standards and specifications prior to release for distribution and use. Tests are conducted with reference to International Conference on Harmonization (ICH) requirements or any relevant regulatory guidance.
Tests undertaken are appropriate to the phase of the drug development. We work with customers to set Finished Product specifications and release test to those specifications accordingly.
Analytical method development
Our analytical development services are customized to your specific needs based on development phase and dosage form. We specialize in establishing robust, reliable, and efficient analytical methods to accurately measure the quality attributes of your products accurately. We conduct testing according to current United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.), and other relevant standards.
Cleaning validation
Our service ensures effective cleaning procedures, preventing cross-contamination and maintaining product quality and safety. We maintain rigorous cleaning validation protocols and adherence to regulatory requirements.
Method validation and verification
Our method validation services ensure the reliability of analytical methods by demonstrating their suitability for intended purposes and their ability to consistently deliver accurate and precise results over time. This process involves documenting validation protocols, results, and conclusions in a comprehensive validation report. Such reports are crucial for regulatory submissions, ensuring traceability and accountability of the analytical method.
ICH Stability Testing
We follow the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (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.
Our environmental stability chambers cover standard ICH conditions from frozen to accelerated (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, -80°C, -20°C, 5°C) and photostability.