Heavy metal analysis meets the latest EP and USP requirements
Pace Analytical Life Sciences (PLS) offers full-service GMP analytical laboratory capabilities for assessing levels of elemental metals / elemental impurities in raw materials, in-process formulations and finished pharmaceutical and medical device products.
PLS provides analytical services to support compliance with Quality Control requirements whether monitoring label-claim or demonstrating control of trace-level elemental impurities as published in the European Pharmacopoeia (EP) chapters 5.20 and 2.4.20 and the United States Pharmacopoeia (USP) general chapters <232> and <233>.
PLS recently completed construction of a dedicated laboratory space for the testing of inorganic analytes including elemental metals, anions and cations. By dedicating laboratory space to this area of testing, PLS is in-step with the upcoming and changing regulations and ready to help clients comply with more stringent testing requirements. Namely, PLS has recognized the significant shift from non-specific, colorimetric tests for heavy metals—which do not always provide accurate, quantifiable results—to the requirements as outlined by the European Pharmacopoeia (EP) in chapters EP 2.4.20 and EP 5.20 and the United States Pharmacopoeia (USP) in general chapters USP <232> and USP <233>.
Elemental Metals Sample Preparation
- Low-temperature Digestion Blocks
- High-temperature Digestion Blocks
- Microwave Digestion
Elemental Metals Testing Instrumentation
- Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)
- Inductively-Coupled Plasma Optical Emission Spectroscopy (ICP-OES)
- Flame-Aspiration Atomic Absorption Spectroscopy (AA)
- Graphite-Furnace Atomic Absorption Spectroscopy (GFAA)
- Cold-Vapor Atomic Absorption Spectroscopy (CVAA)
- Ion Chromatography (IC), Low-level Anions and Cations
Elemental metals may be formulated into products for functional, therapeutic or nutritional benefits, or elemental metals may be natural, process or contaminant impurities. PLS has a broad base of experience in testing materials and products for beneficial minerals and inorganic impurities using any of several instrumental techniques.
Testing for Elemental Metals / Elemental Impurities in Raw Material & Finished Goods
- Formulation Excipients
- Active Pharmaceutical Ingredients (API)
- In-Process Formulations
- Finished Products
Method of Testing for Elemental Metals / Elemental Impurities
- In-house Methods for Screening, USP Class 1 and Class 2 Metals, by ICP-MS
- Qualitative Screening Methods by ICP-OES
- Quantitative Assays
- Custom Method Development & Validation