Extractables Leachables studies
At QACS Lab, we specialize in conducting comprehensive Extractables and Leachables studies for pharmaceuticals. The materials employed in containers closures systems for pharmaceutical products may contain residual monomers various additives and possible breakdown products, but it’s crucial to ensure that these materials do not release substances in any quantity that could compromise the efficacy, stability, or safety of the product.
Extractables and Leachables studies are vital for achieving compliance with regulatory bodies. The custom designed Extractables studies involve meticulous analysis to identify and quantify substances present in the materials of pharmaceutical containers, medical device packages, and single use manufacturing systems which could migrate into the final pharmaceutical product.
Leachables studies are designed to detect traces of the substances identified in the extractables study in addition to a screening for possible unknown Leachables from other sources.
Our testing procedures cover a wide range of organic and inorganic components, including volatile and nonvolatile residues, alongside Elemental Impurities analysis.
Available Testing
At QACS Lab we perform E&L studies using:
- High-performance liquid chromatography (HPLC)
- Gas chromatography mass spectrometry (GC-MS)
- Liquid chromatography mass spectrometry (LC-MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- Ultraviolet-visible spectroscopy (UV-VIS)
- Liquid Chromatography–high-resolution mass spectrometry (LC–HR–MS )
Packaging Testing for Pharmaceuticals is conducted according to methods described in the current editions of Ph.Eur. Monographs (3.1.3), (3.1.4), (3.1.5), (3.1.6), (3.1.15), (3.2.2). At QACS Lab we test for:
- Appearance of solution
- Absorbance Acidity / Alkalinity
- Reducing Substances
- Extractable Al, Ti, Zn
- Extractable Heavy Metals
- Sulfated Ash
- Plastic Additives
- Phenolic and non-phenolic Antioxidants
- Amides and Stearates
- Mechanical Properties
- Oxygen Permeability Testing -OTR
- Leak test
- Real Time, Accelerated (ASTM F1980)
- ICH Storage stability services
Identify & quantify any traces
For L/E studies contact us – [email protected] – +30 210 29 34745