Extractables and Leachables

Extractables and Leachables - GLP compliant testing

Part of formulation development is understanding the interactions of your formulation under different conditions, that may have an adverse effect on the product in real “in use” situations.

We can stress test your product under various conditions to determine the suitability of the Active and determine whether any components or additives may be creating adverse effects such as generating harmful by-products.

Regulators around the globe are becoming more aware of the toxicity of by products, and safe levels are heavily under scrutiny. 

These tests can help to determine any potential future challenges you may face during production, which could cost you heavily in product recalls.

There are various options that could include:

Temperature exposure – accelerated or low temperatures to determine effects on separation, active loss, or impurity formation. These tests may include the use of different packaging types, which should include the pack(s) you intend to market in, as well as something like glass. This will help to support whether your packaging material is interacting with the formulation.

Testing your formulation with different solvents to extract any leachables out that may form over time. 

We can perform a full suite of screening tests, or we can focus on anything that is of particular concern to you or your regulatory authority, such as heavy metals or VOC’s. 

Analysing for potential impurities or elements using our specialised chromatography techniques.

The test design would depend entirely on the chemistry of your product. 

Our Services

New regulations around Biocides came into place in 2012 and we have since worked with industry to support registration needs conducting 5 batch analysis, routine testing, storage stability, physical testing and more on a wide range of Biocides. Find out more here

Biostimulants are a wonderful new way to protect our plants and wildlife by using nature to protect itself. They are natural substances harnessed for their characteristics and developed into products that can be applied to seeds, plants and soils in order to stimulate natural growth. 

We can help with your testing requirements. 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

We can cover elemental to extremely low levels. If you just need to identify, quantify, or fully validate a method. Our ICP systems 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

During the formulation of your product there may be formluation stress tests needed to determine your product will meet regulatory requirements once it undergoes formal GLP analysis. 

Not all labs that formulate have the equipment needed to support the full scope of testing and it may mean failure of the product down the line costing significant amounts.

We can support you develop your formulations and carry out various forms of preliminary physical, chemical and analytical testing to confirm if it meets specifications – or to determine its specifications. Find out more here

The fertiliser market is well established but under scrutiny with the introduction of new regulations demanding more rigorous 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

We have been developing bespoke methods at affordable prices for many years. Our chemists have developed thousands of methods over the years 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

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 and 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

We have worked with consultants and direct customers for many years supporting their Agrochemical registration testing requirements under global regulations. Find out more here

Do you outsource your formulation requirements? We can help you. 

It can be difficult for small companies to find cost effective providers for their formulation needs, and many companies simply will only follow your instruction whether it is chemically correct or not. We will not just formulate for you, we will offer chemistry advice and consultancy as part of our standard service to support you on your journey.

We can prepare your formulation as per your instructions directly, or under the guidance of our chemists. We can also carry out stress testing and preliminary micro preparations to reduce you costs and trial several options at once to find the perfect solution. Find out more here

Need routine quality checks, one offs or concerned about contamination?

New regulations to meet? We often take on complex novel projects and it is what we are known for! Our chemists enjoy doing something different! 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 help students from all over analyse their prepared samples to help them along their journey when they don’t have available instruments.

Find out more here about how we might be able to help.

We can carry out impurity profiling, product screening, method validation and 5 batch analysis or Technical Equivalence studies to meet your registration needs. We develop bespoke methods for your products and can also support with structural identification requirements.

We have many years of experience with successful studies over many compounds from Citric Acid to Pyrethrins covering elemental impurities, isomers, and additives of all types. 

Whether your product is a TC, or TK we can help. Find out more here