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Elemental Impurities Testing of Pharma Materials

BE AGILENT SURE - In your elemental impurities testing of pharma materials

Regulatory bodies worldwide have agreed to new standards for controlling elemental impurities in drug products and ingredients. For example, USP <232>/<233> and ICH Q3D—scheduled for implementation in January 2018—require more elements to be monitored at lower levels than ever before. The new standards also recommend modern analytical procedures, such as ICP-OES and ICP-MS, to quantitate elemental impurities.

Agilent can help your lab implement effective elemental impurities testing, taking an integrated, workflow-based approach to keeping your lab compliant.

On-demand webinar

New Elemental Impurities Tests for Pharmaceutical Products to Start in Less Than One Year. Are You ready?

Speaker: Mark Kelinske
Applications Chemist, Agilent Technologies

The deadline for implementing the new USP and ICH guidelines for elemental impurities in drug products and ingredients is fast approaching. Final revisions to USP <232> have harmonized the analyte list and daily exposure limits with those defined in ICH Q3D.

In this webinar, we will summarize the most recent updates and explain how innovative instrumentation, software tools, qualification, and compliance services can help you meet these new requirements.

Register now

End-to-end support for your elemental impurities testing

Agilent can help you keep abreast of the latest compliance requirements and ensure that your equipment and processes conform. Roll your mouse over each question to see what Agilent can do for your lab.

What sample preparation is needed?

Backed by decades of expertise and worldwide vendor relationships, we can help you select the best sample preparation equipment.

Which instrument best meets my needs?

We can help you choose the most appropriate technique for your lab.

Is my instrument installed and operating correctly?

We offer complete installation, commissioning, and qualification services.

How can I set up a method to meet my requirements?

We supply preset methods for USP <232>/<233> and ICH Q3D to quickly get you operational.

What about procedural and operator training requirements?

Our SOP templates and setup documentation can help you implement best practices, and provide analyst training.

Where do I obtain reliable standards and consumables?

We offer premixed USP/ICH CRM stock solutions, as well as system consumables and parts.

Will I meet Part 11 and Annex 11 regulatory requirements?

We offer a range of compliance software options, suitable for any lab size and type.

Where do I get applications support and instrument services?

Our global team of industry and technical experts can provide training and support.

Simple workflows, reliable results

Measure elemental impurities in pharmaceutical materials with confidence

Confidently measure elemental impurities in pharmaceutical materials

Agilent quadrupole ICP-MS systems perfectly match the demands for elemental impurity analysis in all types of pharmaceutical materials. They enable you to easily measure all 24 USP/ICH regulated elements at the low PDE levels required in parenteral and inhalational medicines—as well as the higher limits that apply to oral dosage forms.

Our 7800 ICP-MS ensures high accuracy and data quality—even with limited sample amounts or large dilution requirements. What’s more, auto-optimization tools, built-in preset methods and reports, and a comprehensive SOP template make the 7800 a productive, easy-to-implement system for manufacturers and contract labs.

7800 ICP-MS

Run fast ICP-OES analysis, using less gas

The Agilent 5110 ICP-OES is well suited for analyzing elemental impurities in bulk ingredients (such as raw materials and excipients), or oral dosage final products. It can measure all 24 regulated elements down to parts-per-billion levels, and can handle samples containing up to 25% total dissolved solids (such as sodium carbonate).

What’s more, the 5110 ICP-OES delivers high speed and reduced cost-per analysis, making it ideal for labs offering contract pharmaceutical analysis services.

5110 ICP-OES

Implement compliant elemental impurities testing capabilities

Pharmaceutical labs must demonstrate and document the suitability of analytical instruments for their intended use. CrossLab qualification services reduce your regulatory risk by:

  • Harmonizing qualification processes and reports across instruments
  • Configuring testing to your SOP requirements
  • Implementing full automation to ensure adherence to protocols
  • Providing an audit-ready Equipment Qualification Report (EQR)

CrossLab service experts to support your continuing analytical and compliance needs with industry and method expertise.

Software, documentation, and supplies

Comply with 21 CFR Part 11 and Annex 11 regulations on electronic records and electronic signatures (ERES)—and ensure data security, integrity, and traceability.

Certified Reference Materials (CRMs) that simplify testing of inorganic contaminants in pharmaceutical products to USP/ICH requirements.

Complete your elemental impurities testing workflow

standards

Parts and Supplies

Simplify your preparation of calibration standards and QCs for USP/ICH elemental impurity analysis with Agilent Certified Reference Materials (CRMs). Our complete CRM kit includes an internal standard mix and four calibration solutions containing all USP/ICH analytes, sorted by class and chemical compatibility.

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CrossLab

Agilent CrossLab

Trust Agilent CrossLab experts to keep your instruments running at top performance. Our industry-leading services—tailored to meet your needs—include automated system qualification, audit-ready equipment qualification reports, preventive maintenance, repairs, application consulting, and education resources. Ask us how we can support your laboratory today.

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