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 Betamethasone Dipropionate Using Epic C18 HPLC Column

Betamethasone dipropionate is classified as a ‘super-potent’ steroid in the treatment of psoriasis in comparison with betamethasone valerate (another common analogue of betamethasone) which is rated as upper mid-strength. This application brief describes the use of an Epic C18 column for the analysis of betamethasone dipropionate in accordance with the official USP monograph.

HPLC Analysis of Finasteride Using an Epic C18 HPLC Column

Finasteride is commonly sold under the brand name Proscar and in 2016 was the 75th most prescribed drug in the USA. This application brief describes the use of an Epic C18 column to analyze finasteride in accordance with the official Finasteride Tablets USP monograph.

HPLC Analysis of Amlodipine Besylate in Accordance with the USP

Amlodipine is listed on the World Health Organization’s (WHO) list of essential medicines as an antihypertensive medicine, meaning that it considered among the safest and most effective compounds needed to meet the requirements of a basic healthcare system. This application brief describes the use of our Epic C18 column to analyze amlodipine besylate in accordance with the official USP monograph.

HPLC Analysis of the Semi-Synthetic Antibiotic Azithromycin Using an Epic C18 Column

The mode of action of azithromycin is like other macrolide antibiotics, it inhibits bacterial protein synthesis by binding to and interfering with the assembly of the 50S large ribosomal subunit of the bacteria, thereby inhibiting translation of mRNA. This application brief describes the use of an Epic C18 column for the simple analysis of azithromycin.

HPLC Analysis of Pregabalin Using Epic C18 Column in Accordance With USP

Pregabalin is an anti-epileptic drug that works by slowing down impulses in the brain that cause seizures. It can also be utilized to treat fibromyalgia, or nerve pain in people with diabetes, herpes zoster, or spinal cord injury owing to its ability to affect chemicals in the brain that send pain signals across the nervous system.