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Butterworth Laboratories

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Butterworth Laboratories

Butterworth is a UK based contract laboratory providing pharmaceutical analysis in accordance with cGMP to the global pharmaceutical industry. We specialise in Quality Control, Method Development & Validation and Stability Storage & Testing. Our focus and expertise centre on raw materials but we also have experience of finished products and medical devices.

Butterworth Laboratories conducts contract analytical chemistry and quality control (QC) activities for the pharmaceutical industry.

Butterworth’s analysis, method development, validation and stability storage and testing services meet current good manufacturing practice (cGMP) requirements.

Quality control analysis of raw materials, intermediates, API and finished products

Butterworth Laboratories provides independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products as an economical option.

The company has extensive experience working with pharmacopoeial monographs, including European (EP) British (BP) United States (USP) and Japanese (JP), internationally published standards, client supplied or in-house developed methods.

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

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

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 the following development.

Stability study design, storage and testing

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 storage of samples, as well as the associated analysis. Services also include testing samples, which are stored at the client’s own facility.

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

The company’s core values are quality, reliability and confidentiality in analytical chemistry outsourcing.

Butterworth aims to meet clients’ needs in a fluctuating environment by understanding their business through regular communication.

Clients are continuously engaged through meetings to discuss current and future requirements, and access will be available to analysts during analysis.

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…
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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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