USP QA/QC Testing Resources

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


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, fulfilling all the requirements described in the monographs for the top generic medicines approved by FDA.

HPLC Analysis of Omeprazole Using LC 300 in Accordance with USP

The World Health Organization regards omeprazole among its ‘List of Essential Medicines’ which outlines the most effective and safest medicines required by a country's healthcare system to meet its needs. The United States Pharmacopeia (USP) closely monitors the production of these drugs and provides monographs for identification and impurity testing of the drug substance.

HPLC Analysis of Pregabalin Using LC 300 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.

HPLC Analysis of Lamotrigine Using LC 300 in Accordance With USP

Lamotrigine is an antiepileptic drug in the phenyl triazine class used in the treatment of both epilepsy and as a mood stabilizer for bipolar disorder. It is the first medication since lithium to be granted US FDA approval for maintenance treatment of bipolar type 1, and is approved for use in more than 30 countries.

HPLC Analysis of Levetiracetam Using LC 300 in Accordance With USP

HPLC Analysis of Levetiracetam Using LC 300 in Accordance With USP

Levetiracetam was approved for medical use in the United States in 1999 and is available as a generic medication. Levetiracetam is a novel anticonvulsant agent used as an adjunct medication to manage partial-onset, myoclonic, and generalized tonic-clonic seizures in patients with epilepsy.

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.