Elemental Impurities in drug products can arise from several sources, including interactions with processing equipment or container/closure systems, presence in the components of the drug product, or even intentionally through residual catalysts added in synthesis. However they got there, the levels of impurities need to be controlled or they can have a negative impact on your final drug product.
In developing controls for elemental impurities in drug products, the principles of quality risk management, described in ICH Q8 and Q9 guidelines, should be considered. The risk assessment should be based on scientific knowledge and is critical to your success.
The ICH Q3D guideline for finished drug products is divided into three parts:
- The evaluation of the toxicity data for potential elemental impurities
- The establishment of a permitted daily exposure (PDE) for each element of toxicological concern
- The application of a risk-based approach to control elemental impurities in drug products
That means you need the right techniques and tools to help you maintain compliance. From sample preparation and instrumentation to our comprehensive toolkit, we offer complete, integrated solutions to ensure your work fully adheres to the guidelines set out in USP <232>/<233> and ICH Q3D.
Software Compliance
Syngistix™ Enhanced Security Software helps pharmaceutical QA/QC laboratories maintain data integrity and regulatory compliance with secure, traceable control of elemental analysis data across PerkinElmer AAS, ICP-OES, and ICP-MS platforms.
- Supports 21 CFR Part 11 compliance with secure user access and electronic records
- Maintains complete data traceability with comprehensive audit trails
- Protects critical results with controlled workflows and secure data management
- Streamlines compliance with easy data review, reporting, and export capabilities
- Increases confidence in analytical results with reliable, reproducible workflows
NexION 1100 ICP-MS
The NexION® 1100 ICP-MS delivers the sensitivity, reliability, and productivity pharmaceutical QA/QC laboratories need for routine elemental impurity testing and regulatory compliance.
- Provides accurate results across complex pharmaceutical matrices
- Simplifies workflows and maximize laboratory productivity
- Supports compliance with USP <232> and ICH Q3D requirements
- Minimizes downtime with a robust, easy-to-use platform
- Generates consistent, defensible data for routine QA/QC testing
Avio 550 Max ICP-OES
The Avio® 550 Max ICP-OES combines true simultaneous performance, advanced spectral capabilities, and exceptional productivity to help pharmaceutical QA/QC laboratories efficiently manage complex elemental analysis workflows.
- Analyzes all elements simultaneously to maximize sample throughput
- Accelerate sample turnaround with fast, efficient analysis.
- Simplifies routine testing with intuitive, easy-to-use workflows
- Confidently handles challenging samples with advanced spectral correction capabilities
- Lowers operating costs while delivering reliable, high-quality results
Avio 220 Max ICP-OES
The Avio® 220 Max ICP-OES provides a flexible, easy-to-use solution for routine pharmaceutical elemental analysis, combining proprietary hybrid simultaneous capabilities with fast, reliable performance.
- Maximizes throughput with unique hybrid simultaneous multi-element analysis
- Allows fast startup, from cold start to analysis in just 10 minutes
- Simplifies routine testing with intuitive, easy-to-use workflows
- Supports compliance with USP <232> and ICH Q3D requirements
- Reduces operating costs while delivering reliable, high-quality results
PinAAcle 900T AAS
The PinAAcle® 900T AAS offers versatile flame and longitudinal Zeeman furnace capabilities in a single platform, providing pharmaceutical QA/QC laboratories with reliable elemental analysis flexibility.
- Allows both flame and graphite furnace AA analyses on one instrument in a space-saving stacked design
- Measures elements across a wide concentration range with exceptional sensitivity
- Simplifies routine pharmaceutical testing with flexible, easy-to-use workflows
- Supports elemental impurities testing with accurate, reliable results
- Maximizes laboratory efficiency while minimizing instrument footprint and cost
MPS 320 Microwave Digestion System
The MPS 320™ Microwave Digestion System delivers reliable, compliant sample preparation for pharmaceutical QA/QC laboratories, supporting elemental analysis workflows across PerkinElmer AAS, ICP-OES, and ICP-MS platforms.
- Ensures data integrity with 21 CFR Part 11-compliant software and audit-ready results
- Achieves consistent, reproducible digestions with high-quality, permanently sealed vessels
- Protects volatile analytes with sealed MR-50 and MR-100 digestion vessels
- Maintains precise control with advanced pressure and temperature monitoring technologies
- Simplifies compliance with IQ/OQ support and flexible data management capabilities
Consumables
Our accessories, consumables, methods, and application support meet the most demanding requirements and are the preferred choice in thousands of laboratories globally.
We test and validate our complete portfolio of solutions to ensure that you receive accurate, repeatable results, on time, every time, throughout the lifetime of your instrument. We also offer a complete portfolio of specialized consumables that deliver reliable performance, control operating costs, and maximize the uptime of your instrument.
Services
The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses pharmacopeial (USP, EP, and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer.
OneSource Compliance Services ensures the highest levels of compliance with international regulations and guidelines. UOQ enables a seamless, cross-platform approach to a contemporaneous and automated documentation process, letting you gain immediate access to raw data from computer or database, for increased scientific productivity.