ELEMENTAL IMPURITY
ANALYSIS & HEAVY METALS
Pharmaceutical quality control and commercial release depend primarily on elemental analysis and trace metals testing. Understanding the elemental composition of raw materials, APIs, excipients, and formulations can ensure product quality and purity. When the elemental composition is unknown, a well-designed strategy is essential to rationalise effort and expense. For patient safety, the heavy metals in pharmaceutical finished products and raw materials must not exceed the specified limit values and must be tested for that. Heavy metals can be introduced into the product by catalysts, synthesis reagents and even by the manufacturing process itself.
Trace metals are hazardous and can impair a formulation’s stability thus the quality control is critical during the manufacturing process. presence of trace species at very low levels and samples with low solubility. Low levels or poor solubility of trace elements complicates the elemental analysis.
Trace metals elemental testing is a routine activity for our Good Manufacturing Practice (GMP) laboratories and is carried out in accordance with pharmacopeia methods such as the United States Pharmacopeia (USP) Chapters USP 232 and USP 233 for elemental impurities or to client specific methods. We also provide combined toxicological risk-assessment and testing compliance services to meet the requirements of ICH Q3D Guidelines for Elemental Impurities.
At VitelyBio, our team is equipped with in-depth subject knowledge & technology to support your analytical testing. Our team applied customized strategic approach to sample preparation for difficult samples and a range of analytical technology, relevant to your needs, including inductively coupled plasma – mass spectrometry (ICP-MS).
We offer method development and validation where required, pharmaceutical analysis or pharmaceutical impurity testing via validated analytical methods and acceptance criteria to support the intended use. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
We provide method development and validation as needed, as well as pharmaceutical analysis and impurity testing via validated analytical methods and acceptance criteria to support the intended usage. We offer Total Quality Assurance experience to help you meet and exceed quality, safety, and regulatory standards by bringing quality and safety to life.