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Butterworth Laboratories Ltd

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Butterworth Laboratories Ltd

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

Pharmaceutical Quality Control Testing

We have extensive experience in the quality control (QC) analysis of raw materials and finished products in accordance with internationally published (EP, BP, USP, JP), client supplied or in-house developed methods.

The use of classical wet chemistry techniques is a requirement for many QC analyses and a key competency of all of our laboratory analysts as we believe this to be the foundation of a good analytical chemist.

We also have a wide range of state-of-the-art analytical instrumentation to compliment our classical competencies, all of which are maintained and qualified to GMP standards. This enables us to provide the most up-to-date and cost effective analytical services.

Raw Material Testing

We consider ourselves experts in the analysis of excipients and active pharmaceutical ingredients (API), the outsourcing of which can often prove to be a cost-effective option for many companies. Lack of instrumentation and expertise, support through periods of high workload and meeting short deadlines are some of the reasons our customers choose to utilise our services.

We have extensive experience in elemental impurities and residual solvents analysis, two key safety ensuring analyses that require considerable knowledge and equipment investment to perform.

Method Development And Validation Services

ButterworthOur wealth of experience in quality control analysis, including practical working knowledge and expert understanding of the techniques employed lends itself directly to the successful development of robust methods for routine quality control analysis.

Method performance is also fully validated to ICH requirements following development. We often perform analysis in parallel with our clients on method validation enabling projects to be delivered in shorter time frames, with the additional benefit of increased robustness and ruggedness.

In addition, we regularly transfer methodology in-house from customers or back to them following development.

Method Verification Services

Material specific verification of methods is vitally important in demonstrating that an existing validated method is suitable for use with a material and that the method can be successfully performed routinely in the laboratory. It can be as simple as demonstrating that system suitability parameters are met but will be dependent on the technique employed.

Stability Storage and Testing Services

We regularly design and set-up real time stability studies under standard controlled conditions as well as stress testing over short periods at elevated temperatures and humidity. We also provide photostability studies, all of which comply with ICH guidelines.

Customer Focus

We believe that the best way to meet your needs is to understand your business, the key to this and to delivering a successful analytical service is good communication. We value meeting with our customers to discuss their current and future requirements, and you will always be able to speak directly to the analyst performing your testing.

Our Commitment To Quality

We are committed to providing the highest quality services and are routinely inspected by the MHRA and FDA as well as our customers for GMP and GLP compliance.

Our Key Techniques

Contact Us

FButterworthor more information about our services or to request a quotation for analysis, please contact us.

Butterworth Laboratories
54-56 Waldegrave Road, Teddington.
Greater London. TW11 8NY.
Tel: +44 (0)20 8977 0750
Fax: +44 (0)20 8943 2624
www.butterworth-labs.co.uk
info@butterworth-labs.co.uk
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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 Ltd
Quick Contact Butterworth Laboratories Ltd
Quick Contact Butterworth Laboratories Ltd


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


Contact Butterworth Laboratories Ltd

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Quick Contact Butterworth Laboratories Ltd