Method Development

The Butterworth staff are experienced at developing methods for both drug substance (API) and drug product (including active ingredient) impurity and excipient assays for clients from the pharmaceutical industry. These same skills can also be applied to manufacturers of medical devices, health and beauty products and fine chemicals, as well as a variety of other industries.

Undertaking method development requires close co-operation with our customers. The more information they can supply on the compound or product in question, the faster a result can be achieved. It is usual to commence with the agreement of objectives, intermediate targets and blocks of work in advance with the customer in writing. Progress reports can then be made by Butterworth staff as each section of work is completed.

The following checklist is used by Butterworth staff when initiating a project:

• Scope of method to be developed
• Type of analytical procedure
• Identification
• Testing for impurities - quantitative or limit
• Assay - content/ potency or dissolution
• Stability indicating
• Type/Range of sample(s) to be tested
• Hazards associated with sample(s)
• Parameter(s) to be determined
• Techniques/ Equipment to be employed
• Analytical parameters to be met:
  • Sample/ product specification
  • Range
  • Precision
  • LOD/LOQ etc
• Reference standards available/ required
• Whether method is to be transferred back to

Butterworth have the relevant facilities to undertake stress testing as outlined in the relevant ICH guidelines for the development of stability indicating methods.

Following development of a method, prior to analysing samples the laboratory, we require the method to be validated to a level agreed with the client.

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