5-Batch Analysis GLP and Impurity Profiling

A GLP approved facility for 5-Batch Analysis of technical materials for an active ingredient, Oxford Analytical can provide you with a comprehensive characterisation and impurity profiling for your 5-batch analysis. Our in depth, analytical laboratory studies are designed to meet high quality standards and are accredited to GLP by the MHRA.

Our dedicated lab staff deliver a fast turnaround, pre-screening of your batches for manufacturing, or other significant impurities. After the detection and characterisation of those impurities, we will arrange a bespoke analysis based on the individual profile. Using our wide range of expertise and instrumental techniques, we are proud to offer you a 5-star service that meets all your 5-batch analysis requirements.

 

A number of regulatory authorities require 5-batch analysis for registration. For example, FAO and IUPAC worldwide, Regulation (EC) 1107/2009 and SANCO 3030/99 for Europe, EPA guidelines OCSPP 830.1700and 830.1800 and 40CFR part 158OPPTS for the USA, ABNT NBR 14029:2005 and NBR 14029-2016 for Brazil, SENASA Argentina, COFEPRIS Mexico. We can tailor your needs to fulfil the requirements of these bodies.

Identifying and quantifying unknown impurities is often challenging. We pride ourselves that our detection processes are conducted in-house under the highest standard of controlled conditions using an array of state-of-the-art equipment. Initial screening is performed using a number of analytical techniques including GC-FID and HPLC-UV followed by characterisation using GC-MS and LC-MS and other relevant instrumentation. 

Once we have created the individual profile from your 5-batch analysis, a highly skilled Study Director will work closely with you on how best to proceed. Oxford Analytical will provide you with continued support throughout your 5-batch project.

A full list of our 5-batch services is:

  • Full analytical profiling of batches
  • Pre-screening Analysis of the active substance to obtain the identification and estimation of the quantification of impurities. 
  • Development and validation of robust analytical methods for the active substance and impurities.
  • Assay of the relevant five batches for quantification of the purity of the active substances and accurate determination of the individual impurities.
  • Low-level contaminant detection 
  • Complete physical testing of water content, sulphated ash, and losses on drying
  • Additional testing based on the individual project requirements

Analytical techniques include, HPLC DAD, LC MS, GC MS, GC FID, and numerous other state of the art equipment to ensure full characterisation of the product.

Oxford Analytical is proud to support small to large businesses and we have collaborated with consultants from the industry for over 25 years. Because every 5-batch project is different, we can refer you to an expert consultant that best suits your individual needs, or we are happy to collaborate with any consultants you may already be using.

So, if you are looking for a 5 batch analysis GLP service that’s cost effective and of the highest quality, the next step is to reach out to us here at Oxford Analytical for a consultation. We will be happy to discuss your project 1-1 and ascertain your individual requirements.

We offer our full expertise to advise you on the best methods and processes available. This includes additional screening for components that are of toxicological or environmental concern.

Oxford Analytical prides itself on being able to offer you the most competitive quote for your 5-batch project.

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