Impurities definition in pharmacy

Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. Compounded medications made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death. USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter provides standards for compounding quality nonsterile preparations. Important Updates • November 8, 2022 – • November 1, 2022 – • May 14, 2022 – Important Note: The currently official version of General Chapter (last revised in 2014) remains official. For information on other compounding chapters Developing USP General Chapter USP is a not-for-profit, science-driven organization that has an The USP Compounding Expert Committee is responsible for the development of General Chapter . Stay Involved: Stakeholder Engagement Your participation is integral to the standard setting process. Stay involved and sign up to receive Resources • • USP Commentary • • Sign up for USP Compounding Updates

The United States Pharmacopeia – National Formulary (USP-NF) includes over 5000 quality standards for medicines, both chemical and biologic; active pharmaceutical ingredients (APIs); and excipients (inactive ingredients). It is the most comprehensive source for medicine quality standards in the world. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. USP is an official quality standard for medicines marketed in the US. In addition, USP is utilized in over 140 countries worldwide and integrated into the laws of more than 40 countries. USP-NF includes three types of quality standards for prescription medicines: • Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria. • General Chapters provide broadly applicable information to industry on accepted processes, tests and methods to support product development and manufacturing for innovative, generic and biosimilar medicines. • Material reference standards are used in conjunction with monographs and general chapters to verify that a medicine and its ingredients can pass tests to ensure adherence to quality requirements. Key components A monograph is a written document that reflects the quality attributes of medicines approved by the U.S. Food and Drug Administration (US FDA). Som...

Differential Scanning Calorimeter (DSC) / Differential Thermal Analyzer (DTA) Simultaneous Thermal Analyzer (STA/TGA-DSC) Thermogravimetric Analyzer (TGA) Dilatometer (DIL) Thermomechanical Analyzer (TMA) Dynamic Mechanical Analyzer (DMA) Multiple Module Calorimeter (MMC) Accelerating Rate Calorimeter (ARC) Dielectric Analyzer (DEA) Light/Laser Flash Analyzer (LFA) Time Domain Thermoreflectance Analyzer (TDTR) Seebeck Analyzer (SBA) Evolved Gas Analyzer (EGA, coupled to Thermal Analyzer) Software Rheometers Heat Flow Meter (HFM) / Guarded Hot Plate/Pipe (GHP) / HotBox Test Chambers (TDW) Fire Testing Systems Refractory Tester Purity Determination of Pharmaceuticals 23.07.2020 by Dr. Gabriele Kaiser The Importance of Purity Determination of Pharmaceuticals The increasing number of product recalls in recent months has again made us aware how important the purity of drug ingredients is. Differential scanning calorimetry (DSC) is able to quickly analyze the absolute purity of chemical compounds within a single run, without the need for a reference standard. The increasing number of product recalls in recent months has again made us aware how important the purity of drug ingredients is. The presence of unwanted chemicals, even in small amounts, may have an influence on the efficacy and safety of pharmaceutical products. Various analytical techniques are employed for purity checks. Among these, What is an Impurity and Where Does it Come From? According to the ICH guidelines (ICH...

Impurity testing is crucial to provide purity, safety and quality control for APIs and drug products. Pharmaceutical impurities may come from different sources, such as: starting materials, reagents, solvents, intermediates, degradation products and excipients and can be both of organic and inorganic origin. Due to the fact that impurities are present at trace levels in complex sample matrixes, its testing requires highly specific methods. Selvita’s GxP compliant laboratory facilities deliver comprehensive analytical support against impurity profiling, identification, certification – in compliance with ICH guidelines. Our scientists have broad experience in suitable method development and validation, especially at demanding low detection levels. Services available: • Custom method development and validation • Product and API specific methodology • Qualitative/quantitive analysis • Organic compounds identification