A method to identify heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago.
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.
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.”
Butterworth uses its expert understanding of techniques employed and practical working knowledge of analysts, ensuring successful method development robust enough for quality control purposes.
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.
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.
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.
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.
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.
In a randomised clinical trial led by a team from Oxford University, a total of 2104 severe Covid-19 hospital patients received therapy of a once-daily 6mg dose of dexamethasone, either by orally or by intravenous injection, for ten days.
Keeping the supply chain of life-saving and life-changing drugs functioning efficiently is demanding under normal circumstances, so the difficulties experienced during these unprecedented times are intensifying an already challenging predicament.
Butterworth Laboratories is pleased to announce that it will be exhibiting at Making Pharmaceuticals Exhibition and Conference at Ricoh Arena in Coventry, England on 26-27 October.
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 Ltd (BLL) has operated in a UK that has been a member of the EEA / EU ever since its establishment in 1974.
Butterworth Laboratories has announced that it will be showcasing its ingredients and laboratory services at Making Pharmaceuticals in Coventry, UK.
Butterworth Pharmaceuticals has announced it will be attending Making Pharmaceuticals in the Richoh Arena, Coventry.
UK contract analytical chemistry provider Butterworth Laboratories is delighted to announce it has secured a facility in Hampton, Middlesex.
Butterworth Labs will be attending Biotech Outsourcing Strategies at the Congress Centre in Basel, Switzerland.