Elemental Impurity Analysis in Cutaneous and Transcutaneous Drug Products Using ICP-MS Based on ICHQ3D (R2)

User Benefits

- Even if Option 1 is used to convert the PDE to the target concentration, the control value can be set at 10 % of the PDE. - The acceptance criteria for accuracy and precision in Quantitative Tests of 2.66 Elemental Impurities in the Japanese Pharmacopoeia 18th Edition can be easily achieved.

Introduction

The ICH Q3D Guideline for Elemental Impurities specifies the Permitted Daily Exposure (PDE) of 24 toxic elements for oral, parenteral, and inhalation routes. In Japan, since the Japanese Pharmacopoeia 18, which describes analytical methods, was announced on June 7, 2021, elemental impurity control must be performed for the drug products specified in the Japanese Pharmacopoeia within a three-year grace period. In addition, the ICH Q3D guideline has been updated to Q3D (R2) and new PDE values have been established for cutaneous and transcutaneous drug products (cutaneous products). After an international agreement on Q3D (R2) has been reached, elemental impurity control should also be considered for cutaneous and transcutaneous routes, as these routes will be listed in each country’s pharmacopeia. In this Application News, white petrolatum and heparinoid oil- based cream, which are in high demand for cutaneous and transcutaneous drug products, were used as test samples and analyzed for class 1 and 2A of elements which require a risk assessment.

June 2, 2022 GMT