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Butterworth Laboratories

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LATEST PRESS RELEASES
February 19, 2024

Butterworth at Making Pharmaceuticals 2024 – 23-24 April in Coventry, UK

Butterworth Laboratories, a company providing contract analytical chemistry services to global pharmaceutical and life sciences companies, will be exhibiting at...
pharmacuetical business review
September 7, 2023

Insight: Helium Supply and the Increase in the Use of Hydrogen as a Gas Chromatography Carrier Gas

Why hydrogen is a serious contender as a gas chromatography carrier
pharmacuetical business review


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Butterworth Laboratories

Butterworth Laboratories provides independent, contract analytical chemistry services to the global pharmaceutical and related industries.

Butterworth Laboratories provides independent, contract analytical chemistry services to the global pharmaceutical and related industries.

Consequently, we are considered leaders in Quality Control Testing, Method Development, Method Validation, Method Transfer, and Stability Testing of pharmaceutical raw materials and finished products, since 1974.

Quality Control – Analysis of raw materials, intermediates, API and finished products

The company provides independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products which can be an economical option for many companies.

Butterworth has extensive experience working to pharmacopoeial monographs, including European (EP) British (BP) United States (USP), Japanese (JP) and more recently the Chinese (ChP), internationally published standards, client-supplied or in-house developed methods

Traditional techniques such as titrimetric, gravimetric and colorimetric analysis are a core competency requirement for the laboratory staff.

State-of-the-art instrumentation complements these and ensures the laboratory provides the most up-to-date and economical analytical services.

Projects – Method development and validation in accordance with ICH guidelines

With a wealth of experience in QC testing, Butterworth is able to bring together, both expert understanding of the technique employed and the practical working knowledge of the analysts to ensure successful method development robust enough for quality control purposes.

Following the development of a method, it is vital that performance is fully validated. Butterworth Laboratories validates methods to ICH guidelines, which is required by most regulatory authorities.

Performing analysis in collaboration with clients on method validation enables projects to be delivered faster, with the benefit of increased robustness and ruggedness.

Butterworth regularly verifies existing methods and transfer methodology in-house from customers or back to them, following development.

The nature of stability studies makes them ideal for outsourcing. Assistance is provided in the design of standard real-time studies, stress testing over short periods at elevated temperatures and photostability studies, in compliance with ICH guidelines.

Butterworth can handle the testing samples, which are stored at the client’s own facility and manage the storage of samples by outsourcing to approved facilities.

Quality compliance

Butterworth is routinely inspected by the Medicines and Healthcare Regulatory Agency (MHRA), US Food and Drug Administration (FDA), and United Kingdom Accreditation Service (UKAS) on GMP, good laboratory practice (GLP) and ISO: 17025 standards, as part of its commitment to meeting the requirements of the pharmaceutical industry.

About Butterworth Laboratories

Pursuing excellence through collaboration – professionally.

For us, our Values are not just words on a website – we encourage all our employees to channel their work and actions to meet these standards so that the company as a whole reflects the Values.

The Vision of the Directors which drives our day to day mission is: “To continue to be a rewarding place to work as the first choice UK laboratory for quality analytical chemistry in the pharmaceutical and related industries.”

Our Mission Statement defines how we, on a day to day basis, aim to achieve the goal set out in our vision.

“Providing excellence in contract analytical chemistry through our core values, talented people, dedication and expertise.”

Contact

Butterworth Laboratories
54-56 Waldegrave Road, Teddington
London
UK

Tel: +44 (0)20 8977 0750
Fax: +44 (0)20 8943 2624
info@butterworth-labs.co.uk
www.butterworth-labs.co.uk

Quality Control Analysis

Independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products are provided by Butterworth. The company has extensive experience working to pharmacopoeial monographs, including European (EP) British (BP) United States (USP) and Japanese (JP), internationally published standards, client supplied or in-house developed methods. Titrimetric, gravimetric and colourimetric analysis is a core competency…

Stability Testing for Drug Substances and Products

Stability testing provides evidence on how the quality of a drug substance or product varies over a given time period and under the influence of environmental factors including temperature, humidity and light. The studies are designed to include testing of attributes susceptible to change during storage and are likely to influence quality, safety and efficacy.…

Method Development and Validation

Butterworth uses its expert understanding of techniques employed and practical working knowledge of analysts, ensuring successful method development robust enough for quality control purposes. Following the development of a method, its performance needs to be fully validated. Butterworth Laboratories validates methods to ICH guidelines, which is required by most regulatory authorities. Performing analysis in collaboration…

Elemental Impurity Analysis in Pharmaceuticals

A method to identify heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Pharmaceutical companies are still using the same method, the USP Heavy Metals Limit Test. The current colourimetric methodology is intended to control metals, which form a sulfide precipitate, such as lead and copper. These metals…

Residual Solvents

Changes to USP chapter residual solvents have affected manufacturers of pharmaceutical products and contract testing laboratories. Butterworth applies headspace analysis to residual solvents and raised concerns with the USP regarding the new procedure including: An aqueous dilution of hydrophobic solvents used in the preparation of standard stock solutions, which lead to inaccuracies due to solvent…
Quick Contact Butterworth Laboratories

Butterworth at Making Pharmaceuticals 2024 – 23-24 April in Coventry, UK

Butterworth Laboratories, a company providing contract analytical chemistry services to global pharmaceutical and life sciences companies, will be exhibiting at...
19th February 2024

Insight: Helium Supply and the Increase in the Use of Hydrogen as a Gas Chromatography Carrier Gas

Why hydrogen is a serious contender as a gas chromatography carrier
7th September 2023

Butterworth Laboratories Continues To Support the Pharmaceutical Industry during COVID-19 Crisis

Contract Analytical Laboratory remains open for business as (almost) usual.
6th April 2020

Meet Butterworth Labs at Biotech Outsourcing Strategies Event

Butterworth Labs will be attending Biotech Outsourcing Strategies at the Congress Center in Basel, Switzerland.
18th July 2018

Butterworth Laboratories Announces New Facility in Hampton, UK

UK contract analytical chemistry provider Butterworth Laboratories is delighted to announce it has secured a facility in Hampton, Middlesex.
31st May 2018

Butterworth Laboratories to Attend Making Pharmaceuticals Event

Butterworth Pharmaceuticals has announced it will be attending Making Pharmaceuticals in the Richoh Arena, Coventry.
24th April 2018
Quick Contact Butterworth Laboratories


Quick Contact Butterworth Laboratories
Quick Contact Butterworth Laboratories
Quick Contact Butterworth Laboratories


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