PDA Letter Article

Hidden Contamination in Starting Materials

by Annette Kirsch, PhD, Merck KGaA


Are Your APIs Free of Dirt?

Contamination by foreign particles has been covered only to a small extent in regulatory and compendial guidelines, and, even then, mostly for parenteral products (1–5). The European Pharmacopoeia only covers particle contamination of oral herbal medicines. (6). To cover this gap, the Active Pharmaceutical Ingredients Committee (APIC) and the International Pharmaceutical Excipients Council (IPEC) published position papers in 2015 explaining how pharmaceutical manufacturers should deal with particles in APIs and excipients (7,8). Additionally, PDA recently stepped in and published Technical Report No. 78: Particulate Matter in Oral Dosage Forms in December 2017 to complement the pharmacopeial guidance for oral dosage forms (9).