At many stages in the manufacturing and packaging of therapeutic products, there are opportunities for contact-based contamination. For scenarios that involve plastics and other primary and secondary packaging or processing materials, there is a growing trend toward identification and regulation of extractable and leachable (E&L) substances that may pose a risk to public health. Extractable compounds are those which can be removed from the contact material by solvents, extreme heat, or other physicochemical extraction. Leachable compounds are those that devolve from packaging materials under typical storage conditions.

Because of the wide variety of substances used in the packaging of therapeutics and the wide range of potential analytes, performing full analysis of extractables and leachables for a delivered product may involve techniques from liquid chromatography-mass spectrometry (LC-MS) for detection of plasticizers to X-ray dispersive fluorescence to detect heavy metals. Shimadzu provides the tools you need to discover the E&L compounds relevant to your workflows, then provide the compliance-ready instrument platforms to monitor and ensure safe manufacturing and distribution.

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Application Notebook - Solutions for Pharmaceutical Impurities


With an ever-increasing consumption of pharmaceutical products by the world population, there are considerable concerns about the unknowns and impurities which are ingested along with these medicinal drugs. The nature of these impurities and their consequent effect may pose a potential hazard to human health. This makes identification, estimation, quantification and control of these impurities matter of great concern and challenge. Regulatory agencies are laying increasingly defined guidelines for different types of impurities both for drug substances and drug products. Chemical properties of these impurities are diverse. Accordingly laboratories need to use variety of analytical equipment like LC-MS/MS, UHPLC, GC-MS, GC-MS/MS, ICP-MS. Shimadzu has been a trusted scientific partner for these analytical equipment, with workflows suitable for impurity analysis and compliance platforms tailor-made for the pharmaceutical business environment. In this handbook, we share a variety of methodologies for different classes of impurities like elemental, organic, residual solvent and more. Methods described are in synchronization with relevant ICH guidelines and create a sound platform for scientists to initiate their quest for answers with confidence.

Thermal Desorption – GCMS Method for Screening Analysis of Extractables in Drug Packaging Materials


Extractables are defined as the compounds that can be extracted from a drug packaging under certain conditions, e.g. in solvent and/or with heating. Meanwhile, leachables are compounds that migrate from the drug packaging into the drug under normal storage conditions. Many regulatory guidance documents have been established regarding extractables and leachables (E&L) approach and assessment. However, details on how to perform E&L evaluation in various packaging materials and products is still under discussion and development. A screening analysis method for extractables in the packaging of ophthalmic solution by thermal desorption (TD) - GCMS was developed in this study. The result is compared with the leachables result of an ophthalmic solution measured by GCMS with liquid injection.

Extractables and Leachables Analysis of Common Household Food Storage Products using a Quadrupole Time-of-Flight (Q-TOF) Mass Spectrometer


Since food contact materials (FCMs) are in direct contact in consumer products, the existence of extractables and leachables (E&L) in the packaging and storage materials can raise health and safety concerns. To address these concerns and comply with the regulations, companies demand methods and techniques to analyze their products for research and development as well as quality assurance purposes. In response to this increasing demand, we developed a method to analyze extractables and leachables in FCMs using a liquid chromatography high accuracy mass spectrometer.

TOC – Determination according to USP 661.1 Testing of Plastic Packaging Systems and their Materials of Construction


Plastic packaging systems for pharmaceutical products must be suitable for their intended use. The US Pharmacopeia revised the related chapter. It is published in USP 39- NF34, which will be valid from May 2016. Besides the change of the title “Plastic Packaging Systems and their Materials of Construction”, two new chapters are established. This application note is related to the first chapter 661.1.

TOC – Determination according to USP 661.2 Testing of Plastic Packaging Systems and their Materials of Construction


In the pharmaceutical industry plastic packaging is used in various forms for example for intravenous bags, bottles, cartridges or pre-filled syringes. The packaging must be tested for suitability for these uses. It is published in USP 39-NF34, which will be valid from May 2016. Besides the change of the title "Plastic Packaging Systems and their materials of Construction", two new chapters are established. This application note is related to the second chapter 661.2.