Each category of assay procedure requires different types of analytical information in order to comply with USP <1225>. The information required for each assay category is as follows:
Category I
Required tests: Accuracy, Precision, Specificity, Linearity, Range
Not required: Detection limit, Quantitation limit
Category II
Required tests: Accuracy, Precision, Specificity, Quantitation Limit, Linearity, and Range for Quantitative Methods. Accuracy, Specificity, Detection limit, Range for Limit Methods.
Not required: Detection limit for quantitative methods is not required. Precision, Quantitation Limit, Linearity and Range are not required for Limit method.
Category III
Required tests: Precision is required. Accuracy, Specificity, Detection Limit, Quantitation Limit, Linearity, and Range are not required.
Category IV
Required: Specificity
Not required: Accuracy, Precision, Detection Limit, Quantitation Limit, Linearity, and Range are not required.
BA Sciences offers extensive experience, expertise, and knowledge in routine testing, method development, and method validation. We are your partner of choice for regulatory and compliance needs. We support pharmaceutical manufacturers and developers to meet regulatory guidelines from industry-specific standards through federal regulations. We maintain the latest testing equipment and expertise to allow us to provide cutting edge testing results.