USP Elemental Impurities Validation
Overview of USP <233> Validation
As required by USP <233>, Galbraith Laboratories validates USP <233> in a new material. This page describes the method validation process as it specifically relates to USP <233>. For general information on our method validation services, please click here.
Every USP <233> validation begins with a proposal (quotation) for the project. When the terms of the proposal are accepted, the client is asked to submit the sample along with a purchase order. Once provided, Galbraith Laboratories will begin the project by conducting the method development experiments.
Method development on USP <233> validations begins with a full elemental analysis. This allows our chemists to evaluate potential interferences and devise digestion conditions for the test material. Once the development experiments are done, Galbraith provides a report on the test results.
Galbraith will write an analytical procedure compliant with USP <233> and customized for your product. The procedure is meant to supplement USP <233> by providing analysis details such as sample mass, digestion conditions, internal standards, etc. This procedure will be approved by the Galbraith QA and the client prior to being considered effective.
Galbraith also creates a method validation protocol that captures the required method characteristics and performance specifications. This document will contain necessary details on the experiments that will be performed and details on the report. Like the procedure, this document will be approved by Galbraith QA and the client before it is effective.
When the development work has been completed and the protocol and analytical procedure are approved, Galbraith will begin the validation experiments. The nature of the experiments depends on whether a limit or quantitative test was indicated. The experiments will comply with cGMP requirements and all data is inspected by Galbraith’s QA Unit.
Once the validation experiments are completed, Galbraith staff will prepare a validation report. The results of all experiments are discussed in the report. The document must be reviewed and approved by the client before the validation is considered complete. Once the validation is complete, Galbraith can provide routine testing of the product using USP <233>.