5-Batch Analysis and Impurity Profiling
We aim to excel in 5 batch testing, offering reliable and accurate results with a focus on practical applications for industries like agriculture and plant protection. Our team, known for its meticulous approach, utilises advanced analytical methods and modern equipment to ensure precise data. We are known as a trusted partner for businesses in the agricultural and plant protection sectors, providing valuable insights into product quality and consistency. By prioritising accuracy and industry standards, we play a crucial role in supporting these industries with essential testing services.
The steps to 5 Batch Analysis
Review the manufacturing process/information provided by the customer
Screen representative batch (or multiple batches if you prefer) to develop a profile of the material. This includes impurity profiling. Various techniques can also be used based on the potential for impurities to be present.
Continue method development as needed to determine the profile to compute at least 98% of the material
Non GLP inspection to confirm % active ingredient is within specification. Also to count impurities of significance (<0.1%), as well as any product relevant/toxic impurities
GLP Validation of the analytical methods for the active and also relevant/significant impurities
GLP 5 Batch Analysis.
The entire process is usually surprisingly fast. Especially considering how complicated it sounds. However it can be completed in a few short months.
Technical Equivalence
These studies are also very similar to 5 batch studies, where they require 5 representative batches to be analysed to confirm they meet a certain specification.
The difference however, is that the product is not new. But it may have had a change to the manufacturing process, changed source or manufacturer.
To clarify the above steps are still followed. However the exception is that the specification will need to be equivalent to that already registered. Otherwise there is a likelihood that additional testing will also be needed.
We have carried out a lot of 5 batch studies over our years in operation. You can see many examples of actives we have worked with on our case studies page, and also examples of equipment available too.
Our Services
Need data for registration or a safety data sheet?
From explosive properties through to partition co-efficient, we cover a wider range of physical tests. We can also develop our own in-house methods for novel experiments.
We use a range of methods from CIPAC, ASTM, ISO, OPPTS, OECD and more to meet global regulatory requirements. Find out more here
New regulations around Biocides came into place in 2012 . We have since therefore worked with industry to support registration needs. These include conducting 5 batch analysis and routine testing, as well as storage stability, in addition physical testing and more on a wide range of Biocides.
Biostimulants are a wonderful new way to protect our plants and wildlife. This is done by using nature to protect itself. They are natural substances harnessed for their characteristics. After that they are developed into various products. These products can be applied to seeds, plants and soils in order to stimulate natural growth.
We have worked with consultants and direct customers for many years supporting their Agrochemical registration testing requirements under global regulations. Find out more here
We can design storage stability studies with or without GLP accreditation under the Biocides, Plant Protection, or ICH guidelines to support registration around the world. Find out more here
We can also cover elemental to extremely low levels. If you just need to identify, quantify, or even fully validate a method. Our ICP systems also cover a wide range of elements often working on 10+ elements simultaneously.
We regularly work on Silver, Lead, Arsenic, Chromium, Cadmium, Mercury, Copper, Boron and Sodium to name a few. Our list of capabilities stretches much longer! Find out more here
Furthermore we can carry out impurity profiling, product screening and method validation. We also carry out 5 batch analysis or Technical Equivalence studies to meet your registration needs. We develop tailored methods for your products. Furthermore we can also support with structural identification requirements.
We also have many years of experience with successful studies over many compounds. From Citric Acid to Pyrethrins covering elemental impurities, isomers, and also additives of all types.
Whether your product is a TC, or TK we can help. Find out more here
We have been developing tailored methods at affordable prices for many years. Our chemists have developed thousands of methods over the years. They range from simple single actives to complex products covering a wide range of levels and product types.
We can also validate already developed methods or support you through your own method development journey via consultation.
Our validation expertise covers global requirements including SANCO/3030/99, SANTE/2020/12830 and ICH Q2, OPPTS 830.1800 and APVMA among others. Find out more here
The fertiliser market is well established. However it has come under scrutiny with the introduction of new regulations. These regulations demand more accurate testing and reducing acceptable levels of elements.
We are one of few labs that can offer the full suite of Fertiliser testing including Inorganic Arsenic, and Chromium VI. Find out more here
Need routine quality checks, one offs or concerned about contamination?
New regulations to meet? We often take on complex unique projects. It is what we are known for! Our chemists enjoy doing something different! Find out more here
Need a reasoned case for a regulator? Trying to develop a product or a method? See what our chemists and consultants can do to help. Find out more here