Impurities - a risk for drug manufacturers and patients
Impurities detected too late in the development phase of a pharmaceutical product can delay product approval. Impurities that are only discovered during the production process can result in delays in market supply. If contaminated pharmaceutical drugs are already on the shelf, expensive recalls and official measures are inevitable. The consequences for the manufacturer are a loss of patient confidence in the efficacy of the preparations on offer, including a loss of brand image and a loss of confidence in the effectiveness of regulatory controls.
Pharmaceutical Analytical Impurities for early detection
Impurities can occur during the entire product life cycle of a pharmaceutical drug - during development, raw material purchasing, production, transportation, and storage. In order to detect an impurity and assess its degree at an early stage in these complex processes, a supplementary tool is required in addition to the use of official reference standards. Many years of experience in cooperation with science, industry, and authorities have led USP to develop its own product range, the Pharmaceutical Analytical Impurities - PAI. PAIs are analytical reference materials for the early detection of impurities in analytical research and development and process development.
The USP PAI portfolio already includes over 550 analytical reference materials for over 130 active pharmaceutical ingredients (APIs) in 20 therapeutic categories. Each USP PAI is supported by its own product information sheet with details of identity and purity.
PAIs can be used in various applications:
- Performing analytical testing during early feasibility studies for formulations
- Determination of degradation impurities, e.g. during stress studies
- Conducting spiking studies during process R&D
- Identification of unknown impurities formed under ICH stability conditions
- Testing for and profiling impurities that are not listed in the monographs for pharmaceutical drugs and drug products
PAIs can help reduce the risk of unsafe levels of impurities in the manufacturing process and increase pharmaceutical drug safety for patients. The availability of nitrosamine impurities (NSDRIs) is just one example.
Order PAI and Reference Standards easily online
Eurofins PHAST GmbH has created a webshop to provide clients with the best possible support when purchasing official reference standards and PAIs. Here clients can conveniently select and order the reference standards and PAIs needed for analyses. Register and test at: www.reference-standards.com/ or contact us at reference-standards@bpt.eurofinseu.com.
Reference standards and PAIs can only be obtained by specialists (pharmaceutical industry - e.g. manufacturers of original preparations and generics as well as phytopharmaceuticals, institutional laboratories, pharmacies).