Small Molecule Identification and Purity Testing
Identity and purity testing are crucial requirements of a lot-release. There are a variety of testing methods to determine drug substances and products to ensure that final drug products match client specifications.
FTIR Spectroscopy Analysis
FTIR (Fourier Transform Infrared Spectroscopy) is an analytical method for determining, polymeric, biological, or in some cases inorganic compounds.
FTIR spectroscopy is used for structural characterisation of both organic and inorganic molecules in:
FTIR It is is a technology that characterises the spectra to identify materials.
In order to identify chemical properties, Infrared radiation is emitted for it to pass through (or reflect off) sample in order to collect raw data from the absorption.
The infrared radiation that is emitted by the FTIR is in the range of 10,000 to 100 cm-1. The sample molecules will then transform the absorbed radiation into vibrational and/or rotational energy.
The signal is presented at the FTIR’s detector as spectrum that ranges from 4000 cm-1 to 400cm-1. The signalled spectrum represents one of your samples molecular fingerprint.
The Fourier Transforms converts the raw data from the infrared emission into a spectrum which Medistri’s laboratory uses to study, analyse and identify the compound.
Since all spectral fingerprints produced by a molecule or chemical structure are unique, FTIR analysis’ are considered an excellent chemical detection method.
When identifying industrially produced compounds, FTIR spectroscopy is considered as a strong technique for quality control.
FTIR Spectroscopy Analysis is frequently recommended as the first stage of your material analysis process.
Bisphenol A (BPA) is a compound used to make certain polycarbonate materials and epoxy resins. BPA’s are used in a variety of products, including packaging, bottling systems, medical devices, and impact-resistant products. Including in the epoxy resins are used on the interior of packaging and piping.
Due to their regular usage in everyday products, there are concerns about the potential harmful effects of BPAs on human health. BPA can migrate from packaging materials and pipes into food and drink, resulting in human exposure to BPA.
Some industries have them classified as carcinogenic and/or mutagenic and/or toxic and have put in place multiple frameworks to regulate the types and the levels of BPA’s in wide range of products. These regulations require some industries to heavily & regularly monitor the presence an amount of these specific compounds. They have been established to monitor either low percentage or part per million (ppm) levels.
A sample is placed in a closed sampling vessel, heated using a known temperature profile, and the vapor in the vessel is sampled for analysis.
GC/MS Analysis (also called Gas Chromatography/ Mass Spectrometry) is an analytical process that utilises the capabilities of Mass Spectrometry and Gas Chromatography in order to determine the chemical compounds within a sample.
GC/MS Analysis are recognised for being one of the most highly reliable and effective analysis for the pharmaceutical, Biotechnology & Medical Device industries.
GC/MS Analysis are also preferable for chemical compounds with low limits of detection. Our customers use our GC/MS Analysis to analysis sample in any size chemical state particularly when sample quantity is restricted.
Medistri’s Laboratory leverages world-class equipments and infrastructure to maintain the highest level of accuracy and precision for our customers most specific applications.
GC/MS Analysis can identify both volatile and semi-volatile chemical compounds. Medistri’s laboratory can analyse both liquid and gas compounds using the direct injection method into gas chromatography - allowing for a large scope of applications:
- VOC & SVOC Testing.
- Residual Analysis.
- Compound Separations.
- Identification and Quantification.
- Material Outgassing Testing.
- Identification of Debris & Contamination.
- Identification Impurities.
- Identification of Potential Extractables and Leachables.
Our laboratory works according to ISO 17025 (current version) and is accredited since 2008 by the Swiss Accreditation Service (SAS). All testing can be performed according to European or US pharmacopeias.
Volatile Organic Compounds (VOCs) Analysis by GC/MS
Volatile organic compounds (also known as VOCs) are compounds that evaporate rapidly from their liquid or solid state into the atmosphere under normal pressure and temperature conditions. VOCs are of concern due to their low boiling points, extensive use, relatively high toxicity, and a high degree of halogenation.
ISO 10993-18 focus on chemical characterisation of medical device material within a risk management process. Part of this process is the identification, quantification of extractables and leachable compounds using gas chromatography/mass spectrometry (GC/MS) technology.
However, this procedure requires rigorous quality control. Therefore, the GC/MS system must be conditioned and prepared before starting the analysis. Volatile Organic Compounds (VOCs) are collected by incubation of the device at 150°C in a sealed vessel using Head-Space Trap Technology and analyzed by gas chromatography-mass spectrometry (GC/MS) which will provide a signal and a identification using NIST ( NIST: National Institute of Standards and Technology) database.
PDMS Analysis by FTIR
PDMS analysis by FTIR is a test that consists of extracting and identifying PDMS residues in a qualitative/semi-quantitative method in pharmaceuticals or medical samples.
Polydimethylsiloxane, commonly called PDMS or dimethicone, belongs to a group of polymeric organosilicon compounds (large molecules formed by the linking of monomers) commonly called silicones. This compound, thanks to its inert and non-toxic components, is frequently used in the pharmaceutical/medical industries.
PDMS is optically transparent and, in general, inert, non-toxic and non-flammable - it is one of many types of silicone oil.
According to ISO 7886-1, sterile, single-use hypodermic syringes used for medical purposes must not exceed a certain concentration of this type of compound, i.e. 0.025mg/cm2.
The analysis consists of using a predefined "pool" of syringes in which dichloromethane (which acts as an extractant) is added to dissolve the silicone. Once the silicone is dissolved, and the extractant evaporated, we will use the "FTIR" equipment to identify the extract by comparing its spectrum with a database.
Medistri's contract Laboratory is located in the heart of Switzerland to continuously serve the countries most innovative universities, research institutes, start-up companies & large enterprises from the Pharmaceutical, MedTech & BioTech industries.
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