[Phytolab 공식대리점 관련 업무대행/수입] Excipients

Apart from active substances and/or functional ingredients, pharmaceuticals, food supplements and cosmetics also contain numerous excipients. These may constitute the physical matrix for the value-adding ingredients, enable technical processability, control the release of active ingredients, increase shelf life or improve flavour, for example. Ascertaining physicochemical and functional quality is therefore just as important for excipients as it is for active ingredients in order to ensure that promises of efficacy are met and patient/consumer safety is assured.

Excipient quality is specifically tested in accordance with the relevant pharmacopoeia monographs and official conventional methods. Standardised methods from such collections as the ISO and EN standards. Although conventional methods may be less complex in technical terms, a high level of experience and stringent quality management in accordance with GMP and/or ISO 17025 are required in order to apply them for reliable, reproducible results. Whether identification testing as per pharmacopoeia monographs, testing for elemental impurities in accordance with ICH-Q3D, for diethylene glycol or ethylene glycol by means of gas chromatography, testing microbiological purity or for potential substance-specific impurities such as PAHs – trust in quality and security for your excipients!

We would also be happy to conduct a risk assessment for possible impurities, such as nitrite/nitrosamines, in your excipients and give you advice regarding the development of specifications.