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What the New Elemental Impurities Regulations Mean for Your Pharma Business

What the New Elemental Impurities Regulations Mean for Your Pharma Business

Many great strides in toxicology over the last few years, supported by significant advancements in analytical instrumentation, have increased knowledge about acceptable levels of metals in consumer products, especially pharmaceuticals.

Previous methods for heavy metals analysis were based on colorimetric assays, for which analysts had to conduct visual inspections. Today’s inductively coupled plasma mass spectrometer (ICP-MS) allows metal species to be detected in drug products at even parts-per-trillion levels.

According to regulations set forth by USP <232>/<233> and ICH Q3D, metals are now sorted into three classifications: Class 1, Class 2A/2B, and Class 3. Permissible daily exposure (PDE) limits have been established based on the route of administration and dosage.

What Pharmaceutical Manufacturers Need to Do

Pharmaceutical manufacturers will have to balance risk with effect to comply with new regulations USP <232>/<233> and ICHQ3D. The most accurate choice is to employ the services of a dependable chemical analysis team to perform analysis of drug products starting from method development and validation.

Teams will need to detect and quantify metals present in pharmaceuticals to determine levels and thus compliance with the limits.

  • Class 1 – pharmaceuticals in this class are toxic no matter the administration method and have no role in pharmaceutical manufacturing.
  • Class 2A/2B – pharmaceuticals in this class are more or less toxic depending on how they are administered.
  • Class 3 – pharmaceuticals in this class are of low toxicity when taken orally, but may need further risk assessment for other delivery methods.

Examples of metals included in each category are as follows:

  • Class 1 Examples – Arsenic (As), cadmium(Cd), mercury(Hg), lead(Pb)
  • Class 2A/2B Examples – Cobalt(Co), vanadium(V), nickel(Ni)
  • Class 3 Examples – Lithium(Li), antimony(Sb), barium(Ba), molybdenum(Mo), copper(Cu), tin(Sn), chromium(Cr)

Once metals are properly classified, they will need to be quantified to determine if they meet or exceed permissible daily exposure limits. If they exceed limits, pharmaceutical formulas will have to be reviewed to identify how they are being introduced to the drug.

Chemical analysis teams can ensure compliance with stricter regulations set forth by USP <232>/<233> and ICH Q3D chapters. Get in touch with Avomeen for elemental impurities testing and analysis. Learn how Avomeen can test your existing and pending drug products and help you meet USP requirements for elemental impurities.