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new USP <232>/<233> and ICH Q3D
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Determining Elemental Impurities in Pharmaceutical Products

New methods and guidelines from United States Pharmacopeia (USP) Chapters USP <232>, <233> and <2232> as well as guidelines from International Conference on Harmonization (ICH observed by the European Medicines Agency (referred as ICH Q3D) set new standards in laboratory analysis and sample preparation for pharmaceutical samples. Determination of elemental impurities in pharmaceutical products can be made from the sources like catalysts, raw materials, production processes, and packaging materials.
The implementation of the new USP chapters <232> and <233> on elemental impurities in January 2018 redefined analysis and sample preparation in pharmaceutical industry.
Milestone offers chemists a practical guidance for determining elemental impurities in pharmaceutical products and dietary supplements.

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Milestone Methods

Application Team of Experts develops hundreds of easy guidelines to tailor your application method.

Application Reports

Written by professionals for professionals, it aims to provide a short and focused technical paper on our technology and application, integrated with analytical data.

Book

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.

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Need to fulfill regulatory requirements?

The Milestone Validation Packages include several protocols in order to fulfill regulatory requirements, such as the Good Manufacturing Practice (GMP) guidelines that, along with our superior support and expertise, will be by your side throughout the whole process. Our experts will support you with the right confi guration, with a dedicated procedure for your samples, with a demonstration of the system’s capabilities and with a complete validation package that includes:DQ (Design Qualification), IQ (Installation Qualification),

OQ (Operational Qualification), PQ (Performance Qualification) and the requalification. All the tests carried out by our service engineers are guaranteed by certified test equipment, providing high accuracy and meeting all the regulatory requirements. Our software is fully compliant with the FDA regulation 21 CFR part 11, with an exhaustive audit trail for complete traceability. The MVP is one of the multiple services offered by Milestone to ensure the highest industry standards in customer support.

Milestones' solutions for Pharmaceutical applications