萃取物和浸润物测试 - 简短的E＆L测试是识别和量化可以从含塑料产品中释放的分子的过程。这篇博客文章讨论了用于分析样品提取物的许多不同的分析技术。
E＆L测试is an essential part of medical device and pharmaceutical packaging testing. Any compounds that could leach out and potentially cause harm must be accurately identified so that they can be eliminated from the product. Failure to do so accurately could result in the product not being approved for use, or even in harm to patients.
E＆L测试is a complex process. Following the extraction phase, where solvents are used to extract compounds from a representative sample of a product, an E&L testing study will typically make use of multiple analytical techniques in order to characterize the tens or even hundreds of compounds present in the extract.
所使用的分析技术和方法的选择对于研究的成功至关重要。如果未彻底分析测试方法缺乏足够的范围或数据，则未检测到从样品中成功提取的化合物。
Characterization of Unknown Compounds
Choosing the correct analytical techniques for a certain E&L testing study is complicated and some wrongly claim that certain single techniques are capable of adequately identifying all unknowns in a sample. In fact, the wide variety of components present in a typical extraction cannot be identified by any one analytical technique.
Extract components can be broadly categorized as either organic (such as monomers and additives) or inorganic (such as metals and salts). Organic compounds can be further categorized as either volatile, semi-volatile and non-volatile. Typically, at least 3 different analytical techniques are required to cover all of these bases.
Organic Unknowns
易挥发的
- 气相色谱质谱法（GCM）
- Headspace GCMS (HGCMS)
- Dynamic Headspace GCMS (D-HMS)
- Desorption Mass Spectroscopy (DMS)
Semi-Volatile
- 气相色谱质谱法（GCM）
- 液相色谱质谱法（LCMS）
- Desorption Mass Spectroscopy (DMS)
非易失性
- Pyrolysis Mass Spectroscopy (PYMS)
- 核磁共振（NMR）
- Fourier Transform Infrared Spectroscopy (FTIR)
- Gel Permeation Chromatography (GPC)
Inorganic Unknowns
Metals
- Inductively Coupled Mass Spectroscopy (ICP-MS)
- X-ray Fluorescence (XRF)
盐
- 离子交换色谱法（IEC）
- Inductively Coupled Mass Spectroscopy (ICP-MS)
选择和应用正确的分析l techniques is vital, but only as a starting point. The success of any E&L testing study relies on rigorous and careful analysis of collected data, and this depends largely on the skill and experience of the analyst.
定量分析
Accurately assessing the risks posed by various leachable compounds requires that their concentration in the extract can be measured. This is often challenging due to the very wide range of possible leachables and the fact that identification of these compounds beyond a molecular formula is challenging if the components are not commercially available.
Quantitative analysis is achieved by two primary methods: formal quantitation, which uses standards of known concentration; and relative quantitation, which uses a surrogate standard with a similar chemistry compared to the unknown. The levels of each component are then compared to the recommended safe limits for those compounds based on guidelines from groups such as thepqriand theEMA.
E＆L测试是验证医疗和药物过程安全性的重要组成部分 - 但没有一定大小的技术。乐动体育登录乔迪实验室很荣幸能提供尖端E＆L测试services enabled by world-leading chemists, state-of-the-art instrumentation, and more than four decades of analytical experience. To find out more,get in touch with usourdownload our E&L Testing white paper here.
