USP <1225>
Method Validation

USP General Chapter <1225> Validation of Compendial Procedures is used in pharmaceutical settings to show that a method will reliably fulfill its intended analytical application. USP General Chapter <1225> outlines the criteria required for a successful method validation, to ensure that the validated method is suitable for its intended use.

Parameters for validation include:

  • Accuracy
  • Precision
  • Specificity
  • Limit of Detection
  • Limit of Quantitation
  • Linearity
  • Range
  • Ruggedness

BA Sciences features expertise in performing method validations that comply with USP <1225> general chapter guidelines for a broad range of test methods and techniques. We provide method development, validation, and full documentation of all procedures to help you fulfill all appropriate regulatory requirements that you may need to meet.

USP <1225> Method Validation Services

BA Sciences offers a full method validation services and capabilities to meet USP <1225> standards, including:

  • Validation protocol development
  • Custom development of validation acceptance criteria and standards
  • Development of stability indicating methods where applicable
  • Forced degradation studies
  • Transfer-ready validated methods
  • Methods tailored to development phases
  • Revalidation after method updates or process changes

Our services and processes are regularly validated to ensure accuracy and the confidence you need in fulfilling your quality standards and requirements.

Applications of USP <1225>

There are a number of compendial assay methods to which USP <1225> should be applied. USP <1225> defines several categories of test method and validation criteria, which are as follows:

Category I: Quantitation of active ingredients or major components, including preservatives, in bulk drug products or finished pharmaceutical products

Category II: Identification, through quantitative assays and limit tests, of impurities in bulk drug products or degradation compounds in finished pharmaceutical products

Category III: Determination of performance characteristics of products; example characteristics include release behavior, dissolution, and others

Category IV: Component and product identification testing

Testing Requirements by Category

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.

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