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Safeguarding-Drugs-Controlling-Elemental-Impurities-ICH-Q3D

Elemental Impurities

Ensuring compliance with ICH Q3D Guidelines

Elemental impurities in medicinal products pose significant risks to patient safety and regulatory compliance. At QbD Group, we provide expert support for analyzing, controlling, and mitigating elemental impurities in accordance with ICH Q3D guidelines. Using state-of-the-art techniques, we help you achieve compliance while ensuring the safety and efficacy of your products.

Discover how we can help you

How can we help?

At QbD Group, we provide comprehensive support for managing elemental impurities:

ICP-MS analyses

ICP-MS analyses

State-of-the-art testing for elemental impurities and heavy metals with low detection limits.

Risk assessments

Risk assessments

Evaluating potential sources of elemental impurities in your processes and materials.

 

Control strategies

Control strategies

Implementing effective plans to manage and mitigate elemental impurities.

Accredited lab services

Accredited lab services

Offering reliable and efficient testing with clear cost visibility upfront.

Elemental Impurities - Lab Services - QbD Group (2)

Why partner with QbD Group?

QbD Group provides unmatched expertise and tailored solutions for managing elemental impurities:

  • Expert knowledge: In-depth understanding of ICH Q3D guidelines and pharmacopoeial standards.

  • Advanced technology: Cutting-edge ICP-MS equipment for precise and reliable results.

  • Efficient processes: Fast turnaround times and transparent cost structures.

  • Comprehensive support: From risk assessment to routine testing, we handle every aspect.

  • Proactive solutions: Guidance on best practices to maintain compliance and product quality.

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What are elemental impurities?

 

Elemental impurities are trace levels of metals that can be introduced into medicinal products during manufacturing, packaging, or storage.

These impurities must be carefully monitored and controlled to meet stringent regulatory requirements and ensure product safety. Key aspects of elemental impurities include:

  • ICH Q3D compliance: Adherence to International Council for Harmonisation (ICH) guidelines for controlling elemental impurities.

  • Testing methods: Conducting analyses using pharmacopoeia procedures, such as ICP-MS (Inductively Coupled Plasma Mass Spectrometry).

Why is monitoring them essential?

 
Elemental impurity monitoring is crucial for:

  • Patient safety: Minimizes toxic risks associated with heavy metals.

  • Regulatory compliance: Meets ICH Q3D and pharmacopoeial requirements.

  • Risk mitigation: Identifies sources of elemental impurities during risk assessments.

  • Product quality: Ensures the integrity of both raw materials and finished products.

  • Streamlined operations: Avoids delays or rejections due to non-compliance.

Questions? Get in touch.

What are elemental impurities?

 

Elemental impurities are trace levels of metals that can be introduced into medicinal products during manufacturing, packaging, or storage.

These impurities must be carefully monitored and controlled to meet stringent regulatory requirements and ensure product safety. Key aspects of elemental impurities include:

  • ICH Q3D compliance: Adherence to International Council for Harmonisation (ICH) guidelines for controlling elemental impurities.

  • Testing methods: Conducting analyses using pharmacopoeia procedures, such as ICP-MS (Inductively Coupled Plasma Mass Spectrometry).

Why is monitoring them essential?

 
Elemental impurity monitoring is crucial for:

  • Patient safety: Minimizes toxic risks associated with heavy metals.

  • Regulatory compliance: Meets ICH Q3D and pharmacopoeial requirements.

  • Risk mitigation: Identifies sources of elemental impurities during risk assessments.

  • Product quality: Ensures the integrity of both raw materials and finished products.

  • Streamlined operations: Avoids delays or rejections due to non-compliance.

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Get in touch

Ready to control elemental impurities in your products?

Ensure compliance with ICH Q3D guidelines and protect your product’s quality with QbD Group’s elemental impurities services. Contact us today to discuss your project and learn how we can support your testing and control needs.

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