Direct measurement of volatiles or residual solvents by selected ion flow tube-mass spectrometry (SIFT-MS) within the headspace of pharmaceutical packaging
Sampling the headspace of pharmaceutical packaging and products by SIFT-MS allows selective determination of trace gases, residual solvents or volatile inorganic and organic compounds which may have originated from excipients or materials used in the manufacturing process or from packaging materials.
Volatile compounds can be harmful to a patient’s health if present at levels that present a toxicological risk. To mitigate risks to human health, potential product recalls and the resulting damage to your brand, a direct and efficient means of measurement of volatile inorganic and organic compounds can be invaluable.
Our experts use SIFT-MS analysis to determine volatiles within the packaging headspace to deliver efficient, selective screening and product testing through, direct quantification of residual solvents such as those listed in ICH Guidelines and USP <467> and VOCs such as aldehydes (including formaldehyde), ketones, esters. SIFT-MS can also determine volatile inorganics such as Hydrogen sulphide, Hydrogen Cyanide or Ammonia.
This approach is highly sensitive, allowing quantification down to sub-parts per-billion (ppb) concentrations with a wide dynamic range possible for each sample. The speed of this technique offers an efficient approach for multiple sample screening.
SIFT-MS separates compounds through gas-phase ion-molecule chemistry. The soft chemical ionisation method of SIFT-MS helps to overcome challenges typically experienced using conventional chromatography approaches including specific challenges with compounds such as formaldehyde, formic acid, and ammonia. As there is no need for derivatisation, the analysis is extremely rapid. The data generated is appropriate for ICH method validation requirements.
It is ideal for determination of volatile residual monomers that may have been released from packaging into the headspace of the packaged product. It can also be used for packaging screening, allowing swift identification of packaging-related issues earlier in the development process. Other applications include rapid analysis of volatile leachables, taint compound detection, measurement of VOCs in the headspace of excipients or any materials used in the manufacture of your products and also continuous dynamic monitoring of released volatiles from a formulation / product over time.
We offer a comprehensive set of packaging related analytical techniques for the pharmaceutical industry including world-class extractables / leachables programs, glass delamination studies and headspace volatiles analysis. With our network of GMP compliant facilities in the USA and Europe, we can help you to identify the risks related to your product or packaging early in your development process.
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