In the chemical industry, a preliminary '5 Batch' analysis is an essential requirement for product registration. It requires the analysis of five or more production batches of the chemical. Analysis are performed according to GLP standards where each amount of an active ingredient is tested and impurities above a set level are identified and quantified.
Why it is required?
The 5-Batch analysis is necessary for the registration of any new/generic product by the manufacturer. By conducting 5-Batch analyses, the manufacturer proves the chemical equivalence to the reference specifications, as per the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).
The aim is to quantify significant impurities ≥0.1% w/w, borderline impurities ≥ 0.06% w/w and toxicological relevant impurities. All other impurities in the< 0.06% w/w category, need to be identified and characterized, whenever and wherever possible or feasible.
Eurofins BioPharma Product Testing Italy, is an accredited GLP facility for 5-Batch analysis of technical materials for active ingredients. We can provide you with a complete characterisation and impurity profiling for your 5-Batch analysis. Our testing solutions comply with global regulatory directives, such as FAO and IUPAC worldwide, Regulation (EC) 1107/2009 and SANCO 3030/99 for the European market, EPA guidelines OCSPP 830.1700and 830.1800 and 40CFR part 158OPPTS for the US market.
