Intertek ASG Laboratory, Manchester, UK

Inks and Colorants Analysis:

Pharmaceutical Products and Formulations

The marking and branding of pharmaceutical products and formulations by solid colour, direct printing or other form of coding is becoming of increasing importance to meet patient safety requirements and meet new standards for security marking. Intertek ASG has extensive experience in colour chemistry with dyes, pigments and their formulation into liquid inks and materials. This, combined with a GLP and GMP compliant laboratory environment, ensures that Intertek ASG is well placed to solve problems of measurement and analysis in the development and manufacture of these specialist materials. Intertek ASG is able to support the requirements of expert witness programmes.

Examples of specialist technologies relevant to the dye and pigment precursors include:

Detection of heavy metal contaminants to trace levels (sub ppm) in organic matrices
Detection of potentially toxic organic residues from manufacture of the base chromophore such as aromatic amine related derivatives
Assessment of chromophores by UV/vis and related spectroscopic methodologies
Reflectance spectroscopy for pigments
Identification and quantitation of surfactants and dispersants commonly used in colourant formulations
Identification and quantitation of dye molecules by LC-MS
Identification and quantification of polymer and resin components in coated products
For pigments, morphology by XRD (for different crystal components and polymorphic forms) and sensitive thermal analysis for presence of varying hydrates

Information can be provided on formulated products through studies of aggregation phenomena and distribution of surfactants and dispersants. Studies can also be carried out on materials after application to the finished product using a range of physical characterisation techniques including light and electron microscopy, and AFM. These techniques can be important for assessing issues such as chromophore distribution in the product, ink penetration into a substrate or properties of the final cured film for security marked products.

For applications of inks and markings in indirect contact with the pharmaceutical product (e.g. on primary packaging surfaces), Intertek ASG is also able to offer an extractables/leachables service.