Pharmaceutical Elemental Impurities Analysis

The purpose of elemental analysis of pharmaceutical products is to identify impurities that may contaminate the drug. In order to ensure that all pharmaceutical product components and their manufacturing procedures are in compliance, the pharmacopoeia has clearly established wet chemistry procedures for analyzing heavy elemental impurities in pharmaceutical products. All potential sources of impurities in pharmaceuticals include excipients, water, the active pharmaceutical ingredient itself, as well as container systems and manufacturing processes.

Our Analysis Procedure

BOC Sciences offers wet chemical analytical services specifically designed to meet the requirements of USP<232>Elemental Impurities - Limits and<233>Elemental Impurities - Procedures. Our team has established a complete analysis procedure to assess the presence of elemental impurities in excipients, drug substances, and products.

Qualitative Screening Methods

Our experts have developed and validated two in-house methodologies for the detection and quantification of elemental impurities in water-soluble materials and products. Our screening methods are designed to qualitatively determine the presence of any element of concern in a given matrix and provide rough estimates of elemental concentrations consistent with the default concentration limits for USP drug substances and excipients.

• Analysis of USP Class 1 impurities such as Cd, Pb, As and Hg by ICP-MS
• Analysis of USP Group 2 impurities such as Ir, Os, Pd, Pt, Rh, Ru, Cr, Mo, Ni, V, and Cu by ICP-MS

Method Development for Specific Elements

We also develop element-specific analytical methods if the qualitative screening method evaluation results in the identification of the elemental impurity of interest, or if the test article is not water-soluble. Our element-specific method development will include an evaluation of accuracy, precision and specificity in the presence of the test article (spiked sample).

Element-specific Method Validation

We recommend the following method attributes for the validation of quantitative assays: accuracy/range, systematic/method precision, intermediate precision, linearity, specificity, LOD/LOQ, robustness, and solution stability. For limit test methods, the attributes of specificity, limit of detection (LOD), and accuracy (at defined limits) are generally recommended.

Our Technologies - ICP Wet Chemical Analysis

Inductively coupled plasma, or ICP analysis, is a powerful chemical analysis method that can be used to identify trace amounts and major concentrations of virtually all elements in pharmaceutical products. ICP is also referred to as 'wet' chemical analysis due to the nature of the metal solution being analyzed. BOC Sciences offers a wide range of ICP analysis services, including ICP Mass Spectrometry (ICP-MS) and ICP Atomic Emission Spectroscopy (ICP-AES), also known as ICP Optical Emission Spectroscopy (ICP-OES). Combined with advanced ICP testing instruments, our experts can analyze a wide range of chemical compositions including metals, and non-metals.

Figure 2. Potential sources of metallic impurities during the production process of drugs and pharmaceuticals. (Balaram, V. 2017)

Available ICP Testing

BOC Sciences offers several types of ICP testing and analysis procedures, including ICP-AES and ICP-MS. ICP-AES can detect trace and major concentrations of various elements down to parts per billion (ppb), while ICP-MS has lower detection limits down to parts per trillion (ppt). In addition, our ICP analysis labs support ICP-OES analysis to identify and quantify the elements present in the sample.

ICP Testing and Analysis Capabilities

BOC Sciences' ICP analytical services range from environmental compliance testing, chemical composition testing, and analysis of regulated compounds in pharmaceutical products. Our analytical experts are familiar with compliance testing and pharmaceutical industry standards to help determine the best method to meet your ultimate goals. Whether you need pharmaceutical raw material validation or unknown trace analysis in a drug product, our ICP testing and analytical services can provide reliable and accurate test results.