DIN Standards Committee Materials Testing
DIN 53010-1
Rheometry and Viscometry - Pharmaceutical, cosmetic and medical products/devices - Testing the rheological properties - Part 1: Determination of the viscoelastic behavior of semisolid preparations using an oscillatory rheometer by amplitude sweep
Rheometrie und Viskosimetrie - Pharmazeutische, kosmetische und Medizin-Produkte - Prüfung der rheologischen Eigenschaften - Teil 1: Bestimmung des viskoelastischen Verhaltens von halbfesten Zubereitungen mit einem Oszillationsrheometer mittels Amplitudenversuch
Overview
In collaboration with Working Group NA 002-00-07-16 AK "Rheometrie" ("Rheology") at DIN Standards Committee Coatings and Coating Materials (NAB), Working Committee NA 062-08-31 AA "Viskosimetrie und Rheometrie" ("Viscosimetry and Rheometry") at DIN Standards Committee Materials Testing (NMP) prepared this draft standard in order to specify methods for characterizing the rheological properties of semisolid preparations. Oscillatory rheometry is used for this purpose. Oscillatory measurements, for example using an amplitude test, can also be used to describe the viscoelastic behavior of the respective test sample and to differentiate between the elastic and viscous material properties. Rotational measurements can be used to determine shear viscosity. This document applies to semisolid preparations, which include ointments, creams, gels, and pastes. Regulatory aspects are of secondary importance in product categorization; that is, pharmaceuticals, medical devices, and cosmetics may all be taken into consideration. Semisolid preparations within the meaning of this standard are stable at rest. Stability is defined as the presence of a yield point. Preparations of this type exhibit the properties of a viscoelastic solid at rest but behave like a liquid above the yield point. However, preparations that are liquid at rest and lack stability are not considered in this document.
