We at Chromak Research are experts in the critical evaluation and testing of elemental impurities to ensure the safety and efficacy of pharmaceuticals. Elemental impurities are trace amounts of metals like lead, arsenic, and cadmium, which may be toxicologically relevant. Such impurities from diverse sources could be present during production and could play a very influential role in the quality of the final therapeutic product.

What Are Elemental Impurities?

Elemental impurities are trace levels of metals that can be present in drug products. They must be carefully controlled to avoid any possible health risks. Elemental impurity testing is important to meet regulatory requirements and ensure patient safety.

Regulatory Guidelines and Standards.

The International Council for Harmonisation (ICH) offers cornerstone guidelines for the control of elemental impurities in pharmaceuticals. The ICH Q3D Guideline specifies allowable daily exposures (PDEs) specific to various routes of administration, such as oral, inhalation, and parenteral. Supplemental to these are the US Pharmacopeia (USP) chapters <232> “Elemental Impurities—Limits” and <233> “Elemental Impurities—Procedures,” which provide the basis for measuring and controlling elemental impurities. USP <665> is centered on risk assessment and testing methodology for equipment used in manufacturing and processing.

ICH Elemental Impurities and Their Classification

Elemental impurities are classified by the FDA according to their potential for toxicity:

Established human toxicants (As, Cd, Hg, Pb) that present a high risk

  • Highly toxic-probable elements (Co, Ni, V)

Less toxic-probable elements (Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, Tl)

Elements (Ba, Cr, Cu, Li, Mo, Sb, Sn) that are to be considered for risk assessment by route of administration

Sources of Elemental Impurities

Sources of elemental impurities in pharmaceuticals can be classified in four general ways:

Unintentional addition of impurities by the use of impure drug substances, excipients, or reagents during drug product preparation

Contamination or leaching from equipment used in manufacturing and processing.

Residual catalysts or intentional addition of inorganic reagents during synthesis.

Container closure system leaching.

Elemental Impurities Testing at Chromak Research

Chromak Research Laboratory, being a recognized national/international standard and cGMP-certified laboratory, has an impeccable record of offering up-to-date elemental impurity testing services to numerous pharmaceutical and chemical industries. We at Chromak Research with our well-furnished state-of-the-art laboratory, can analyze and track elemental impurities as per the client’s requirements by employing various methods such as Mass Spectroscopy (MS), ICP-MS, ICP-OES, Atomic Absorption Spectroscopy (AAS), etc. In collaboration with our clients, we work to find the optimal approach that will yield the most appropriate, dependable, accurate, and reproducible information with rapid turnaround time according to ICHQ3D and USP <232> & <233>.

Why Chromak Research?

Choosing Chromak Research for your elemental impurities testing needs ensures:

  • ICH, FDA, and USP compliance.
  • The most modern analytical instrumentation.
  • Expert elemental impurities risk assessment capabilities.
  • Fully complete and accurate test results that ensure product safety and efficacy.
  • Personalized service from a professional staff, committed to the success of your project.

We are dedicated to helping the pharmaceutical industry produce safe, effective, and quality drugs at Chromak Research. Allow us to be your ally in the complexities of elemental impurities and complete regulatory compliance. Your safety, our science—let’s advance healthcare together.”.