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Description

This two-day course expands on the key elements of USP-NF General Chapter <1010> concerning acceptable statistical concepts and practices for the analysis and interpretation of analytical data. Special emphasis is given to making statistical inference using statistical interval approaches, use of the right statistical methods to establish comparability, sample size calculation for significance and equivalent tests, outlier detection, and application of variance component analysis to tease out variations from different sources. In addition, the new proposed USP General Chapter <1210> Statistical Tools for Method Validation and its relationship with USP General Chapter <1225> will be introduced.

Miscellaneous

Certificate of Analysis (specimen)

Reference Material CoA specimen: for the current lot, please contact your customer service representative at info@labmix24.com

Product data sheet

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USP | United States Pharmacopeia

US Pharmacopeia Standards set a global benchmark, enabling efficient, reliable, and cost-effective development and quality control of pharmaceuticals.

Official USP Reference Standards are highly characterized physical specimens intended for quality control use when conducting assays and tests for medicines as described in the USP-NF. When you conduct tests and assays required by the USP-NF using the USP reference standards specified, the results can be considered conclusive.

As a USP-Authorized Distributor, we offer the following products and services:

  • USP Reference Standards
  • USP Pharmaceutical Analytical Impurities
  • USP Training and educational programs