The official requirements for 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.
This collection of application briefs and notes demonstrates the use of PerkinElmer LC 300 HPLC System and PerkinElmer Epic™ C18 HPLC Columns, fulfilling all the requirements described in the monographs for the top generic medicines approved by FDA.
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.
This application brief describes the use of an ES Industries Epic C18 column for the analysis of Acetaminophen, Aspirin and Caffeine in accordance with the official Acetaminophen, Aspirin and Caffeine Tablets United States Pharmacopeia (USP) method for the assay.
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.
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.
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.
The methods for assessing Lamotrigine related compound B are described in the United States Pharmacopeia1 and rely on chromatographic techniques. This application brief describes use of an Epic C18 column coupled with the LC 300 liquid chromatography system and SimplicityChrom chromatography data system (CDS).
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.