As a pharmaceutical manufacturer, you would like to carry out a leaching analysis in accordance with USP 1663 and USP 1664.
What is a leaching risk?
Leaching risk, in the context of the pharmaceutical industry and packaging materials, refers to the potential transfer of chemical substances 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 drug they contain. This migration process is often referred to as “leaching”.
What are the risks of leaching?
Risks associated with leaching include:
What do USP 1663 and USP 1664 say?
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.
USP 1663
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.
USP 1664
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
USP 233 analytical validation for elemental impurity analysis
ICH Q3D analysis of heavy metals and elemental impurities by ICP-MS
OUR TECHNICAL RESOURCES
Thermal analysis: ATG, ATG-FTIR, DSC
Powder analysis: XRD, SEM-FEG EDX, BET, Laser particle size analysis
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
