Research and Development Support
Testing support for product research and development.
Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.
Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, dissolution, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.
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Sample Characterization using Thermogravimetric Analysis (TGA)
Thermogravimetric Analysis (TGA) involves the determination of the change in weight of a sample as a function of temperature and/or time of heating.
Weight loss information is useful in the characterization of materials and in problem solving. The TGA instrument used at Impact Analytical is a TA Instruments Q50. The Q50 is ideal for projects in basic research or production support. The instrument has an integral mass flow control, gas switching capability (nitrogen or air), and superb software which provides quality results for each analysis.
A key component of the TGA is the gas composition in the furnace.
TGA is performed either in an inert nitrogen environment or in an oxidative environment (air). In certain sample types, different mechanisms of degradation may be present in oxidative and inert environments. Thus, the number of degradation steps and the temperatures at which the steps occur can be studied in different environments.
The TGA instrument at Impact Analytical has been qualified for use from ambient temperature to
1000 °C, in compliance with: U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP) Regulations, 21 CFR Parts 210 and 211, and the United States Pharmacopeia (USP), General Chapters <891> Thermal Analysis.
This instrument is capable of measuring using just a few milligrams of sample. Samples can be analyzed in accordance with various standard methods including ASTM E1131, ASTM E1868, ASTM E2008 and ASTM D6370.
The most common sample matrices applicable for TGA analysis include:
The most common TGA analyses requested are to determine:
- Degree of hydration: In most cases, surface adsorbed water can be differentiated from water within a crystal lattice, as well as that of a non-aqueous solvent
- Level of residual solvent or moisture
- Thermal Stability: Many sample types undergo thermal decomposition as a function of temperature. It is not uncommon for a sample to decompose in multiple steps.
Examples of other studies suitable for a TGA include:
- Oxidative stability
- Decomposition kinetics
- Copolymer or polymer blend characterization
- Polymers for the presence of fillers, and additives such as flame retardants
- Polymer degradation, including under oxidative environments
- Ash content