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Dear Readers, Welcome to the latest issue of The Magazine
Pharmaceutical element analysis and trace metals analysis are crucial for drug product quality management and commercial release. Understanding the elemental composition of your raw materials, active pharmaceutical ingredients (APIs), excipients, or formulations aids in the quality and purity of your product. When the elemental composition is unknown, a strategic strategy is essential to rationalize effort and expense. Trace metals are hazardous and can impair formulation stability and catalyst degradation. As a result, control during the manufacturing process is critical. The presence of trace species at extremely low quantities, as well as materials with low solubility, can all provide analytical obstacles to elemental analysis.
The ICH Q3D guidelines have now been revised and implemented, with the correction of Permissible Daily Exposures (PDEs) for gold (updates to oral, parenteral, and inhalant PDEs), silver (updates to parenteral and inhalant PDEs) and nickel (update to inhalant PDE only) as well as the correction of gold and silver monographs. Furthermore, limits have been added for elemental impurities by the Cutaneous and Transcutaneous administration route.
Trace metal impurities, originating from raw materials or production processes, pose risks to human health as well as the quality and efficacy of pharmaceutical products.
Regulatory guidelines require the specific quantitative analysis of pharmaceutical products – primarily utilising inductively coupled plasma techniques such as ICP-MS. These analytical techniques require frequent calibration and may also require spike and recovery tests, and reference standards for control samples. In addition, traceable standards are necessary for IQ/OQ reports.
ICH Q3D Guidelines, USP <232> and USP <233> have been in routine use for many manufacturers and distributors of pharmaceuticals and related products. The allowed Permissible Daily Exposure (PDE) is specific to each impurity metal. Concentrations for calibration and spikes in the analytical run are determined by a calculated J-value (see Figure 1), as in the example shown.
The ICH Q3D guidelines have now been revised and implemented, with the correction of PDEs for gold (updates to oral, parenteral, and inhalant PDEs), silver (updates to parenteral and inhalant PDEs) and nickel (update to inhalant PDE only) as well as the correction of gold and silver monographs. Furthermore, limits have been added for elemental impurities by the Cutaneous and Transcutaneous administration route.
LGC Standards ICH-USP Certified Reference Materials (CRMs) can greatly simplify the calculations needed to achieve method conformance for the widest range of analytes in a given sample because we have configured the stock concentrations according to specified PDE. LGC CRMs are at concentrations that allow a simple dilution to meet the required J value for any product. This allows for the greatest degree of efficiency of each analysis, reduction in the potential labor of sample preparation and elimination of the often-complicated calculations involved when using single element CRMs.
Oral and Parenteral administration routes have unique PDE values according to the method, thus we have certified reference materials available for each supporting both revision 1 (R1) and revision 2 (R2) of ICH Q3D.
For ICP-MS, proper choice of an internal standard is also critical to success. Use of internal standards with the ICP-MS technique is different than those employed with familiar liquid chromatography (LC) methods. Internal standard elements are chosen for (a) mass proximity to analytes, (b) suitably matched ionization to each analyte, especially for low ionization elements such as arsenic (As). LGC Standards have optimized multi-element products for internal standard implementation, well suited across the range of available ICP-MS instrument commercial brands.
Kits for ICH (R1 and R2) / USP Methods are available that are concentration-matched for both Oral and Parenteral type sample groups. These kits bundle the necessary CRM products required for the particular sample group that applies.
Custom blends of nearly any configuration can also be provided; as well, to meet unique needs based on analyte, concentration or blend arrangement. Please contact one of our offices to inquire about custom CRM to meet your needs. All products are prepared from high purity raw materials, high grades of acids and 18 Mohm DI water. Total confidence in certified concentrations is ensured by VHG brand advanced QC and assay procedures known as the NIST High Performance ICP-AES method with ICP-MS purity verification.
Each standard that LGC produces for USP and ICH Q3D compliance meets the stringent requirements of ISO 17034 and ships with a comprehensive, NIST (National Institute of Standards and Technology) traceable certificate of analysis.
