Pharmaceutical Testing Services
Supporting drug development with pharmaceutical testing is some of the most exciting work we do. As a premier cGMP contract service laboratory, PTL partners with pharmaceutical scientists to identify key physical characteristics of pharmaceutical APIs and excipients ranging from powders, solids and liquids.
With over a decade of experience testing a vast array of pharmaceutical products, PTL’s analytical staff uses custom-designed test methods for particle size, particle shape, surface area, pore volume, pore size, thermal analysis, powder flowability and zeta potential analyses.
We can provide third party verification of your material, or assist with identifying differences between problem batches / lots. We can provide QC analysis for process control or generate data to include in your certificate of analysis. These are just a very few of the ways we are helping clients with their pharmaceutical samples.
Utilizing our wide array of analytical techniques in the field of particle characterization, PTL provides the comprehensive source for physical testing of your pharmaceutical samples. We provide insight throughout the drug development pipeline; starting with R&D and method development to product scale-up and finally, method validation for FDA approval. The techniques at our disposal are applicable to your raw materials and final dosage forms. United States Pharmacopoeia (USP) and the International Standards Organization (ISO) provide guidance documents for the numerous techniques we employ, providing additional creditability to your results.
Our specialties are in pharmaceutical testing method development, method validation, and method transfer services.
Our Laboratory is cGMP compliant, registered with the FDA and holds a DEA and ATF permit.
Particle Size and Shape Analysis Image Analysis is a powerful analytical technique which can provide additional information on a sample compared to just “particle size” and distribution. The majority of particle sizing techniques...
Nitrogen Gas Physisorption - Includes B.E.T. (Static Pressure / Volumetric Technique) Click here for a typical sample report Pore diameter range ~7 - 4000 angstroms (0.0007 - 0.4 microns) 10 – Point Adsorption and Desorption Isotherm (and...
B.E.T. Specific Surface Area Dynamic Flow Technique Static Pressure / Volumetric Technique 1 – Point Analysis 3 – Point Analysis 5 – Point Analysis Click here for an example output Click here to request...
Image Analysis - Microscopy Services Image Analysis Automated Image Analysis offers particle size distribution as well as shape. Other parameters measured are Circle Equivalent Diameter, Length, Width, Perimeter,...
Sieve Analyses Sieving has been around since the time of the Egyptians and can be considered the backbone of particle size technology. Sieving’s continuing popularity is due to the technique’s fundamentally...
Mercury Intrusion Porosimetry Mercury porosimetry is a powerful technique utilized for the evaluation of porosity, pore size distribution, and pore volume (among others) to characterize a wide variety of solid and powder materials....
Powder Flowability Freeman FT4 Powder Rheometer The flowability characteristic of a powder is directly related to both the physical properties of the material itself, as well as the specific processing conditions in...
Particle Size Distribution Analyses - Electrozone Coulter Counter Technique Electric Sensing Zone is also referred to as the Coulter Technique or Coulter Counter. The instrument is a true high resolution, high speed particle counter and particle...