USP QA/QC Testing Resources

Collection of LC Application Resources in Accordance with United States Pharmacopeia (USP) Methods

Introduction

The official requirements for the United States Pharmacopeia can be found in the general notices, individual monographs, and general tests and assays chapters. Monographs contain tests, procedures, and criteria to ensure the identity, strength, quality, and purity of the active pharmaceutical ingredient (API) and drug product.

But it isn’t always easy to find all the information necessary to set up a method for a given assay. This is why we’re providing easy-to-follow applications to help your lab adopt and offer new methods for the analysis of a wide variety of pharmaceuticals.

This collection of application briefs and notes demonstrates the use of PerkinElmer LC 300 HPLC System and PerkinElmer Epic HPLC Columns, fulfilling all the requirements described in the monographs for the top generic medicines approved by FDA.

HPLC Analysis of Finasteride Using LC 300 in Accordance with the USP

Finasteride is an antiandrogenic compound or ‘testosterone blocker’ which is used as a treatment for an enlarged prostate and can treat male hair loss. It inhibits the production of the enzyme Type-II 5a-reductase which converts testosterone into the more active metabolite 5a-dihydrotestosterone (DHT). DHT is responsible for the development and enlargement of the prostate and can contribute to hair loss by shortening hair follicles and causing them to fall out more quickly.

HPLC Analysis of Betamethasone Dipropionate

Glucocorticoid steroids work by suppressing various aspects of the human immune system in conditions where hyperactivity can cause poor health through allergies, inflammation, and autoimmune dysfunction.