Safeguarding Health: Precise Detection of Elemental Impurities
Elemental impurities in drug products, drug delivery components and systems are of significant concern on your journey to market. These impurities, which include both metallic and non-metallic elements, may exceed established limits and originate from sources like raw materials, processing equipment, or packaging materials. Their potential toxicity poses serious health risks to patients.
Ensuring Elemental Safety
Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established guidelines for controlling elemental impurities in drug products and medical devices. These guidelines require manufacturers to test elemental impurities using various analytical techniques such as inductively coupled plasma-mass spectrometry (ICP-MS) and atomic absorption spectroscopy (AAS). The results obtained from elemental impurity testing ensure that the product meets the required safety standards and is safe for use.
Gateway's Commitment to Safe Healthcare
These guidelines require manufacturers to test elemental impurities using various analytical techniques such as inductively coupled plasma-mass spectrometry (ICP-MS) and atomic absorption spectroscopy (AAS). The results obtained from elemental impurity testing ensure that the product meets the required safety standards and is safe for use. It is vital to control the presence of elemental impurities in E&L studies to ensure the safety and efficacy of products used in healthcare.
Detect, Analyze, Protect
Elemental impurities can also be present in pharmaceutical and medical device industries’ extractable and leachable (E&L) studies. These impurities can migrate from the product into the environment or directly into the patient during use, which can affect the safety and efficacy of the product. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) have established guidelines for controlling elemental impurities in extractables and leachables.
