Gateway Analytical provides a unique set of analytical testing services to support drug product development, quality testing, and reverse engineering of semi-solid formulations including gels, creams and ointments. Whether developing a novel drug product or working to be first to market with your generic equivalent, Gateway Analytical can be an integral partner to your success.
Analytical Testing Services Include:
- Ingredient-specific particle size distribution (PSD) measurements
- Identification and PSD analysis of agglomerated materials
- Measurement of drug PSD over time as part of stability testing support
- Characterization of polymorphs in a drug product
- Characterization of drug phase – dissolved or precipitated
- Localization of drug and excipient materials
- Content uniformity of drug materials
- Identification of particulate contamination
- Analysis of product packaging
Consulting Services Include:
- Method development and validation protocol for services listed above
- Failure and root cause analysis
- Particulate contamination analysis & source determination
Utilize our analytical testing and consulting expertise to help with drug development and formulation, ensuring product performance, and delivering the highest quality product you can.
Gateway Analytical is an FDA Registered, ISO 9001:2008 certified laboratory and performs many of the services listed above in a cGMP-compliant laboratory environment.
Contact us for to request a quote or ask for more information regarding our analytical testing services for semi-solid drug products.