Elemental Analysis ICH Q3D


September 2022: Revision of the ICH Q3D Guideline

What will change for you?

  • New routes of absorption: Until now, pharmaceutical products that are ingested orally, inhaled or parenterally were subject to the guideline. What is new is that the risk analysis must also be carried out for the cutaneous and transcutaneous routes of absorption (e.g. ointments, creams, lotions).
  • Change in limits: new limits apply in ICH Q3D(R2) for the elements gold (Au), silver (Ag) and nickel (Ni).

The ICH Q3D guideline on elemental impurities in pharmaceutical products is highly complex and challenging for both drug manufacturers and raw material suppliers. Drugs that have not undergone a risk analysis in line with ICH Q3D will no longer be approved in the future.

We are pleased to support you in meeting the requirements! Call us or use the contact form!

The complete package for risk analysis in line with ICH Q3D

Supplier certificates, literature data and even empirical values can be used as indicators of possible elemental impurities in your product. Elemental or metallic impurities of this kind can come from abrasion particles in production, natural raw materials or as a result of migrating materials out of packaging.

However, the sources, elements and limits vary to such a degree that additional screenings using appropriate analytical methods should be an integral component of the risk analysis for each finished medicinal product. There is just one problem – the ICH Q3D guideline on elemental impurities does not name any specific analytical methods.

Based on a thorough examination of the guideline, we can offer you a specially developed screening method for detecting elemental contaminants in active ingredients, ancillary materials and finished medicinal products. Our complete package for supporting risk analysis in line with ICH Q3D includes quantitative analysis for 46 elements. We have already validated this method on a matrix-independent basis.

Depending on the outcome of the risk analysis, we optimize and validate product-/element-specific methods and carry out ongoing checks for you on finished medicinal products and/or active ingredients and raw/ancillary materials, as well as packaging.

Standardized screening method

The screening method for finished medicinal products and raw materials, which we have developed in-house, covers 46 elements. It combines microwave-assisted acid digestion and mass spectrometry with inductively coupled plasma (ICP-MS), and has been validated by us on a matrix-independent basis. Digestion and ICP-MS analyses are, of course, carried out and documented in line with GMP. You will also receive a detailed test report.

Continuous checks through risk analysis

Depending on the requirements of the risk analysis, we optimize and validate product-specific tests. Our recommendations for the most suitable measuring technology to use in these tests are based on a variety of factors and parameters, including:

  • Elements that need to be detected under GMP conditions
  • Product-specific limit values
  • Validation specifications (ICH Q3D, USP, Ph. Eur, etc.)
  • Matrix/composition of the material being tested
  • Number of samples to be analyzed annually
  • Time constraints
  • Low analysis costs

We carry out the necessary validations and documentation for you in line with GMP specifications. We also help you evaluate the results, and provide advice and support for your particular issues.

Our evaluations can help you minimize risks, ensuring you are well equipped to meet the extensive range of specifications laid out in the ICH Q3D guideline.

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