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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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Clinical Trial Sample Analysis

This is the quality control analysis of products to be administered during a clinical trial and has the aim of ensuring safety prior to use. It can also be the analysis of biological samples taken from the patient during a trial. The latter requires additional GCP controls within a laboratory quality system to ensure patient safety.

For more information visit our website.

GLP Laboratory Services

GLP studies are carried out at the pre-clinical stage of development and are aimed at providing data on the safety of materials used in a medicine. These studies are strictly controlled and compliance is regulated by the appropriate regulatory body, in the UK this is the MHRA.

Butterworth Laboratories have been a member of the UK Good Laboratory Practice (GLP) Compliance Programme since 1989.For more information visit our website.

Method Development Validation Services

Method Development ensures a procedure is designed for determining an analyte in a specific sample. This includes choosing the most appropriate sample preparation method and analytical technique. Subsequent method validation ensures that the method is specific, linear over the desired range, accurate, precise and robust. This ensures that it is fit for purpose and can be routinely reproduced in a laboratory setting by any suitably trained analyst.

We have many years of method development and validation experience particularly in techniques such as HPLC, GC, IC, AAS and ICP.For more information visit our website.

Pharmaceutical QC Testing

Quality Control (QC) analysis of pharmaceutical raw materials and finished products to cGMP ensures compliance with international standards and ultimately helps to ensure patient safety.

Techniques routinely used are:ChromatographyGeneral & Wet ChemistryPhys/Chem TestingSpectroscopy - AtomicSpectroscopy - MolecularElemental MicroanalysisFor more information visit our website.

Stability Storage and Testing Services

Stability studies are performed to assess material or product performance over time by means of storage under controlled conditions of temperature, humidity and light. Analysis at a variety of time intervals helps to ensure the safety and efficacy over the designated shelf life.

For more information visit our website.
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


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