Butterworth Laboratories

Contract Analytical Chemistry Services and Quality Control Testing

Butterworth Laboratories, 54-56 Waldegrave Road, Teddington, TW11 8NY,London, United Kingdom

Butterworth Laboratories, 54-56 Waldegrave Road, Teddington, TW11 8NY,London, United Kingdom



Butterworth Laboratories is a fully independent laboratory providing contract analytical chemistry services to the pharmaceutical and related industries.

Butterworth specialises in quality control (QC) analysis, method development, validation and stability storage and testing, in accordance with current good manufacturing practice (cGMP).

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 have 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

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

State-of-the-art instrumentation compliment 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 are 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.

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.

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.

Residual Solvents

Changes to USP Chapter Residual Solvents have affected manufacturers of pharmaceutical products and contract testing laboratories.

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.

Quality Control Analysis

Independent certification of raw materials, intermediates, active pharmaceutical ingredients (API) and finished products are provided by Butterworth.

Residual Solvents to USP <467> and <1467>

At Butterworth Laboratories Ltd we understand the importance of keeping up with changes in the Pharmacopoeias and ensuring their implementation. A revision of USP, Residual Solvents.

How Virtualisation Can Help Electronic Data Retention

One of the most discussed topics currently affecting good manufacturing practices (GMP) laboratories, data integrity involves conforming to fundamental elements of quality: attributable, legible, contemporaneous, original, and accurate (ALCOA). Of these, legibility presents a particularly tough challenge.

Genotoxic Impurities

Over the past decade or so, the issue of impurities present in pharmaceuticals which may be DNA-reactive has caused regulators and manufacturers significant problems.

Hosting Client Audits and Regulatory Inspections Remotely

In early 2020, Butterworth Laboratories Ltd (Butterworth) were eagerly anticipating a letter from the MHRA informing us of the intent to carry out a regulatory inspection of our premises, as our last inspection had been in August 2017.

Butterworth’s Statement on Brexit

Butterworth Laboratories Ltd, a UK-based a contract analytical chemistry testing laboratory working principally in the pharmaceutical market, has been continuously monitoring Brexit and its potential outcome over the last 12 months.

Butterworth Laboratories

Butterworth Laboratories

54-56 Waldegrave Road, Teddington

TW11 8NY

London

United Kingdom

Daniel Morland +44 (0)20 8977 0750 +44 (0)20 8943 2624 www.butterworth-labs.co.uk