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Pharmaceutical Factory - Quality Control

Analytical Method Development Services

 Exeter Analytical (UK) Ltd provides analytical method development services for organisations which currently have no suitable procedure in place and need a reliable, fit-for-purpose testing method. Our team develop bespoke methods for pharmaceutical, clinical, agrochemical, environmental, battery technology, and industrial materials.

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As an independent analytical development laboratory established in 1994, we take on the samples other laboratories find difficult: complex matrices, low-level analytes, novel formulations and materials where standard pharmacopeial approaches are not directly applicable. Our team can create bespoke methods that support project objectives, regulatory requirements, and long-term testing programmes.

CALL OUR TEAM ON 024 7632 3223 FOR A QUOTE

1994

EST.

What Is Analytical Method Development?

Analytical method development is the process of designing an analytical procedure capable of measuring a specific analyte, in a specific matrix, to a defined level of accuracy and precision. Method development services cover technique selection, sample preparation, instrument conditions, calibration strategy and the preliminary performance checks that confirm a method is worth taking forward.

 

It is distinct from method validation, which demonstrates that a developed method performs as intended.

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Method development is typically required when:

  • No standard method exists for your analyte or matrix

  • An existing method fails on your sample type due to interference, recovery or solubility issues

  • A product has been reformulated, and the original method no longer applies

  • Lower detection limits or tighter precision are required than the current method delivers

  • A method is being transferred between laboratories or instruments

  • Existing procedure needs rebuilding due to changes to regulatory expectations

Our Method Development Process

Although every project is scoped individually, our approach follows a consistent structure that keeps development efficient and the outcome tenable.

1. Requirements & Analytical Target Profile

We start with the question the method needs to answer. What analyte, what matrix, what concentration range, what precision, what regulatory context, what throughput. Defining this analytical target profile up front keeps development focused on the performance your method actually has to deliver.

2. Sample Assessment & Feasibility

Our team examine representative samples to understand matrix composition, homogeneity, stability, and potential interferences. This stage often identifies the real technical challenge before any instrument time is committed.

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Scientist inspecting pharmaceutical sample in fume cupboard in laboratory

3. Technique Selection

We select the analytical technique or combination of techniques which are best suited to the analyte and matrix. As an analytical laboratory operating since 1994, we can draw on our full range of instrumentation rather than forcing the sample onto a single platform.

4. Sample Preparation Development

For difficult matrices, sample preparation is where methods succeed or fail. We develop and optimise digestion, extraction, dissolution and combustion procedures.

5. Optimisation & Parameter Refinement

Instrument conditions, calibration ranges, internal standards and run parameters are refined to maximise sensitivity and minimise variability. We evaluate the factors most likely to affect robustness in routine use, so the method survives when introduced to the production schedule.

Analytical Techniques We Develop Methods Around

Our laboratory operates a broad range of instrumentation, which means technique selection is driven by what the sample needs rather than what is available.​

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•    ICP-OES — trace and major element determination including full elemental scans and heavy metals testing 
•    CHN elemental analysis — carbon, hydrogen, nitrogen determination on our CE440 elemental analyser
•    Ion chromatography — anion and cation determination in aqueous and digested samples
•    Sulphated ash and residue determination — inorganic residue quantification for pharmaceutical and chemical products
•    Moisture content testing — loss-on-drying approaches
•    pH testing and analysis and classical wet chemistry — titrimetric and gravimetric methods where instrumental approaches are unsuitable
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Explore the full range of elemental analysis laboratory services.​​​

Sample Types And Matrices We Develop Methods For

We regularly develop methods for materials where composition is complex, unusual or poorly characterised.

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•             Pharmaceuticals — active ingredients, excipients, intermediates and finished formulations

•             Energy and battery technology — cathode materials, electrolytes, precursors and recycled cell components

•             Basic and industrial chemicals — commodity and speciality chemical products

•             Polymers and plastics — additives, fillers, residual monomers and elemental content

•             Agrochemicals — formulations, actives and technical materials

•             Minerals, construction materials, cosmetics, food and textiles

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See all industries we support.

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From Development to Validation And Routine Testing

Method development rarely sits in isolation. Most clients need a method that will go on to be validated, transferred or run routinely — and we support the whole path.

Method Validation

Once a method is developed, analytical method validation formally demonstrates performance against accuracy, precision, specificity, linearity, range and robustness. It helps generate the documentation required for compliance and audit readiness.

QC And Batch Release Testing

Developed methods can move straight into routine QC testing services, with consistent reporting and fast turnaround for batch release and raw material verification.

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Why Choose Exeter Analytical As Your Analytical Development Laboratory

Over 30 Years Of Specialist Experience

Established in 1994, Exeter Analytical (UK) Ltd has spent three decades developing analytical methods for organisations across regulated and specialist industries.

Difficult Samples Are Our Normal Work

Complex matrices, low-level analytes and materials that resist standard preparation are routine here, including HF digestion capability for samples that will not dissolve by conventional means.

Direct Access to The Scientists Doing The Work

You speak directly to the analysts developing your method, not an account manager. Technical questions get technical answers.

Independent And Impartial

As an independent laboratory we have no commercial bias in the outcome of your testing, only in the accuracy of the result.

CALL US TODAY ON 024 7632 3223 FOR A QUOTE

Frequently Asked Questions

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Ready To Develop a Method For Your Project?

Partner with Exeter Analytical (UK) Ltd to develop a reliable, fit-for-purpose analytical method tailored to your samples, objectives, and testing requirements. Contact our team today to discuss your project.

 024 7632 3223

EXETER ANALYTICAL UK LIMITED, registered as a limited company in England and Wales under company number: 12523543. 

Registered Company Address: University Of Warwick Science Park, The Venture Centre, Sir William Lyons Road, Coventry, West Midlands, CV4 7EZ

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CONTACT

024 7632 3223

info@exeteranalytical.co.uk

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VISIT

The Venture Centre

Sir William Lyons Rd

University Of Warwick Science Park
Coventry
CV4 7EZ

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