As a pharmaceutical manufacturer, you wish to perform a leaching analysis in accordance with USP 1663 and USP 1664.
Understanding the impact of USP 1663 and 1664 on E&L analysis following USP 661-2.
Switching to USP 661-2 is the first step in ensuring that plastic packaging does not contaminate medicines.
USP 1663: identification of extractables
USP 1664: identification of leachables
What are USP 1663 and USP 1664 about?
USP 1663 and USP 1664 are United States Pharmacopeia (USP) guidelines focused on assessing the leaching risks of packaging materials in contact with pharmaceutical products.
This section focuses on the identification and quantification of extractable compounds likely to be released from packaging materials into the drug. This includes establishing protocols for the extraction and analysis of chemical compounds that could migrate from packaging or delivery systems into the drug product. The aim is to understand the profile of extractables to assess potential risks to drug stability and patient safety.
This section complements USP 1663 by focusing on leachates, i.e. chemical compounds that are actually transferred from the packaging material to the drug product under normal conditions of use. USP 1664 aims to assess the impact of leachates on the quality, efficacy and safety of the drug product, using analytical methods to detect and quantify these compounds.
FILAB supports pharmaceutical manufacturers in leaching analysis according to USP 1663 and USP 1664
Why choose FILAB for your USP 1663 and USP 1664 analyses?
The FILAB laboratory, expert in materials analysis and characterization, offers guidance to manufacturers on how to assess and control potential contamination of pharmaceutical products by packaging materials.
Our services
Analysis of heavy metals and elemental impurities ICH Q3D by ICP-MS
Analytical development in the laboratory using ICP-MS or ICP-AES
Analytical validation according to USP 233 for the analysis of elemental impurities
What is leaching risk?
The risk of leaching, in the context of the pharmaceutical industry and packaging materials, refers to the potential for chemical substances to transfer from the packaging material to the pharmaceutical product.
This phenomenon can occur when chemical compounds present in packaging materials, such as plastics, rubbers, inks, adhesives, and coatings, migrate into the medicine they contain. This migration process is often referred to as ‘leaching’.
What are the risks associated with leaching?
The risks associated with leaching include:
Did you know?
FILAB laboratory is COFRAC ISO 17025 accredited on the following scope, since 2015: Analysis and determination of elemental impurities and minerals including heavy metals by ICP-AES and ICP-MS in cosmetic and pharmaceutical products according to European Pharmacopoeia 2.4.20 and USP 233
FAQ
DSC helps identify the thermal profiles of materials, enabling the detection of structural changes that may influence the release of substances in pharmaceutical products.
