Preparing for New Regulations of Elemental Impurities in Drugs

Drug and dietary supplement manufacturers face an increasingly complex set of elemental impurity standards, which we will detail here.

USP 232/233/2232

The United States Pharmacopeial Convention (USP) says manufacturers can use both current standards and the new standards. You can read more about changes on the USP site.

RQM+ Lab Services is already helping drug and dietary supplement manufacturers comply with the new USP 232/233/2232 regulations.

Our team of PhD chemists have experience identifying USP 232 impurities in drug delivery systems using an Agilent 7900 ICP-MS instrument, which excels at determining trace and ultra-trace amounts of deleterious elements.

ICH Q3D

Separately, since 2014, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has had guideline which apply to new finished drug products (as defined in ICH Q6A and Q6B) and new drug products containing existing drug substances. The drug products containing purified proteins and polypeptides (including proteins and polypeptides produced from recombinant or non-recombinant origins), their derivatives, and products of which they are components (e.g., conjugates) are within the scope of this guideline, as are drug products containing synthetically produced polypeptides, polynucleotides, and oligosaccharides.

Our team of PhD analytical chemists has extensive experience helping companies with regulatory testing services.

Contact us to see how we can help your company with comply with the complex and evolving regulations for drug manufacturers.