A method to identify heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago.
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.
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.
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.