Butterworth Laboratories Ltd

Teddington, 
United Kingdom
  • Booth: 2908

Leaders in Pharmaceutical Analysis Butterworth Laboratories Ltd are a UK based contract laboratory providing analytical chemistry services to the global pharmaceutical industry in support of R&D, Clinical Development and Licensed Manufacture. We are GLP, GCP and GMP compliant and FDA and MHRA inspected. We have extensive experience in the analysis of raw materials, finished products, devices and packaging in accordance with internationally published (EP, BP, USP, JP, JPE), client supplied or in-house developed methods. A wide range of state-of-the-art analytical instrumentation compliment our classical competencies, enabling us to provide the most up-to-date and cost effective analytical services.


 Products

  • Pharmaceutical Quality Control Analysis
    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, JPE), 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
    Full analytical chemistry qualification to international (EP, BP, USP, JP, JPE) requirements...

  • 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
    Development and Validation and methods in accordance with ICH guidelines....

  • 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, in accordance with ICH guidelines, 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.

    Our 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.

    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.

  • Method Verification Services
    cGMP Method Verification...

  • 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. 
  • GLP Studies
    GLP studies in support of pre-clinical development...

  • 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.

  • GCP Analysis
    Analysis of IMPs and Trial Samples...

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