Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Headspace Moisture Analysis (HMA) / Frequency Modulation Spectroscopy (FMS) (CAT#: STEM-B-0413-CJ)

HMA measures the absorption of a laser light with a wavelength of 1,400 nm that passes through the gaseous headspace of a vial containing the freeze-dried drug product. The water content in the headspace is determined by using a calibration curve from standards of known water vapor concentrations. Since absorption is dependent on the path-length and influenced by the optical properties of the container, container-specific standards are constructed. The output parameter of HMA is water vapor pressure in mbar. Results from HMA can also be converted to cake moisture, if a correlation to results from Karl-Fischer titration [KFT] is established.

Biopharmaceutica

1. Start up the moisture analyzer, pick or set testing parameters.
2. Put a sample in a tared dish (or sample pan) and close the lid to start the drying process.
3. The analysis happens while the sample is drying.

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more
• Equipment: FMS Analysis Laboratory Instruments

• HMA can be used during formulation development, lyophilization process development as well as for quality control testing of freeze-dried products.
• A low residual moisture is important for the long-term stability of lyophilized drug products and thus an essential parameter when performing stability studies.
• HMA is used for container closure integrity testing.
• A major benefit of HMA over orthogonal techniques, such as KFT and thermo-gravimetric analysis (TGA), is its non-destructive nature, allowing for 100% testing of drug products or a subsequent analysis of the same vial using other techniques.
• The analysis time is short and its performance straightforward.