Compliance to the USP revised methods will take effect by January 1, 2018
New methods and guidelines are coming from United States Pharmacopeia (USP) Chapters USP <232>, <233> and <2232>, and counterpart guidelines from International Conference on Harmonization (ICH), which are observed by the European Medicines Agency and referred to as ICH Q3D.
At Milestone, we help chemists offering a practical guidance for determining Elemental Impurities in Pharmaceutical Products and Dietary Supplements.
What are the right tools to do the job?
Elemental impurities in pharmaceutical products can be introduced from a number of sources, including catalysts, raw materials, production processes, and packaging materials.
Solve the puzzle
The implementation of the new USP chapters <232> and <233> on elemental impurities, in January 2018, will redefine how the pharmaceutical industry tests for elemental impurities in drug products.
Complete Sample Preparation Guide
Ideal circumstances the sample under investigation is in a liquid form, so it can be diluted in an aqueous or organic solvent or aspirated without any prior sample preparation.
However, if the sample is a solid or powdered material, chances are that it will have to be digested either via an open-vessel hot plate dissolution technique using concentrated mineral acids, or with a closed-vessel, microwave digestion procedure.
Milestone created this primer to provide QA/QC practitioners and Lab Managers insight into the evolution and current status of methods and guidelines for the determination of elemental impurities, whilst educating in the best practices and optimum workflows for this demanding application.
Getting your laboratory ready for implementation
In this web training, we will educate attendees on the method requirements, define key parameters, and discuss considerations laboratories should make as they get themselves ready to implement the new methods. We discussed the importance of sample preparation and choosing the correct analytical technique.
Key Learning Objectives
• Review and discuss latest requirements of USP <232> and <233>
• Determining whether to use ICP-OES or ICP-MS
• Importance, options, and best practices for sample preparation
• How to manage the timeline for validating the new methods
• Real world examples for analysis
Documentation WORTH a READ
Milestone has prepared a complete package with suggestions on how to deal with Microwave-Assisted Sample Preparation and Determination of Elemental Impurities in Pharmaceutical Products.
Our Application Team of Experts remains at your disposal for any tailored solution you may need.
From a User Perspective: Case studies
As most of you are aware, the soon to be replaced USP Heavy Metals Limit test has been in existence for over 100 years. The USP was not capable of individually determining the concentration of each metal in a specific sample. It was a qualitative analysis capable of only giving a combined concentration result of heavy metals at a detection level of a possible 3 to 10 ppm.
Now elemental impurities can be isolated and determined at levels unachievable by the soon to be replaced USP <231> and </231>.
Read how some important global companies managed to meet the new regulatory requirements.