Skip to Content
Merck
HomeProductsAnalytical ChemistryReference MaterialsInorganic Elemental Impurity Mix Standards

Inorganic Elemental Impurity Mix Standards

Detection of elemental impurities in drug products as per ICH Q3D guidelines

Drug products may contain metal elemental impurities that present a risk to patient health. Elemental impurity levels must be monitored and should be below the daily intake levels set in the ICH Q3D guidelines. 

In 2009, the International Conference on Harmonization (ICH) outlined a global policy for limiting metal impurities in drug products and ingredients. This approach required clear regulatory guidance on specification limits for elemental impurities and for national regulatory bodies to provide transparent and comparable results. The ICH classified elemental impurities in four different categories to facilitate decision making during risk assessment processes. 

Beginning on January 1, 2018, the USP and the EP adopted ICH Q3D guidelines for elemental impurity limits. This resulted in an analytical method change for the determination of metal sulfide precipitation from colorimetric determination to analysis by ICP-OES or ICP-MS methods. We offer a wide selection of certified reference materials of different elemental impurity mixes and single elements with concentration limits in accordance ICHQ3D guidelines.

Read more about

Elemental impurity mixes

Our products include standard mixes of TraceCERT® certified reference materials for different elements. They consist of element ratios corresponding to the oral, parenteral, and inhalation elemental concentration limits defined in ICHQ3D guidelines. They can be used for tests according to USP<232>, Ph. Eur. Gen. Chapter 5.20, as well as a mix for USP<2232> for dietary supplements.

  • Products are made and analyzed under ISO/IEC 17025 and ISO 17034
  • Product values are traceable to at least two independent references (NIST®, BAM, or SI unit kg)
  • Convenient 100 mL pack sizes
  • Packed in opaque bottles (FEP) and gas-tight, aluminum foil bags for extended stability
  • Certificates provided in accordance with ISO Guide 31

Single element certified reference material solutions

For each classified and non-classified element, we offer single-element certified reference material solutions, under the Certipur® trademark, in addition to TraceCERT® brand, and NIST® SRM® selection.

  • Suitable for inductively coupled plasma-optical emission spectrometry (ICP-OES) and inductively coupled plasma-mass spectrometry (ICP-MS) applications
  • Available in multiple concentrations of 10 g/L, 1 g/L, 10 mg/L, and 1 mg/L.
  • Tested for approximately 70 impurities
  • Supplied in 100 mL HDPE or borosilicate glass bottles

Additionally, we offer multielement standard solutions in 100 mL HDPE bottles. The bottles are sealed in aluminum bags along with a certificate providing detailed documentation of uncertainty values, expiry date, and storage information.

Related Applications
Mass Spectrometry
Mass spectrometry (MS) is an analytical tool used to identify compounds, determine chemical structure, and assess isotopic abundance. In MS, samples are ionized, and the resulting ions are identified based on their mass-to-charge (m/z) ratios.
Calibration, Qualification & Validation
Reference materials selection is vital for accurate testing, supporting method validation, calibration, and measurement uncertainty assessment.
Atomic Spectroscopy Overview
Atomic spectroscopy uses the energy absorbed or emitted by electrons to identify and quantify the elemental composition of a sample. It includes various analytical techniques, such as AAS, AES, FAA, GFAA, ICP-OES, ICP-MS and XRF.
Related Product Categories
ICP & AAS standards
Enhance inorganic trace analysis with our certified AAS and ICP standards. NIST-traceable solutions available.
Analytical Reference Standards
Explore our broad spectrum of reference materials including pharmaceutical primary & secondary standards, impurities, extractables & leachables, microbiological, phytochemical and physical property standards that support your analytical workflow across the drug manufacturing process.
Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?