In anticipation of the official implementation of the United States Pharmacopoeia Chapter <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures in August of 2015, pharmaceutical manufacturers are turning to their supply chain for higher purity raw materials that are already tested to more rigid standards.
USP<232> outlines a number of proposed changes, including increasing the Permitted Daily Exposure (PDE) limits from 10 to 16 analytes with the addition of the PGE catalyst elements Pt, Pd, Ru, Rh, Os and Ir. Furthermore, the maximum permitted levels will be defined according to toxicity, rather than method capability.
One of the primary goals of the proposed new USP General Chapters is to replace the current subjective, 100 year-old colorimetric test defined in USP General Chapter <231> with new analytical methods based on modern instrumentation such as ICP-MS and ICP-OES.
Although there are differences in the type of spectroscopy utilized to analyze for trace metals, both ICP techniques are capable of detecting very low levels of these impurities. Of the two, ICP-MS is capable of detecting lower concentrations, often down to the part per trillion level. ICP-OES, though not as sensitive, is still capable of measuring most trace metals in the parts per billion (ppb) range.
Instead, pharmaceutical companies are looking to source higher purity raw materials from their supply chain. By purchasing from U.S-based batch manufacturers that already routinely utilize ICP testing, such as GFS Chemicals, they hope to reap the rewards of greater transparency and consistency of product.
The Ohio-based GFS manufactures a variety of high purity and low trace metal grade organic and inorganic chemicals for the pharmaceutical industry. The company specializes in producing a customized product to the customer's exact specifications.
All of GFS' incoming raw materials and finished products are tested using ICP-OES equipment. GFS is transparent with its testing methods and shares the results with customers, when requested.
This is in sharp contrast to some foreign raw material suppliers that run continuous processing and do not perform such testing, leading to variability even within what is considered to be a single lot.
In addition to benefiting from the ICP testing, there are many advantages to working with a true domestic manufacturer such as GFS. This includes an ability to address any quality issues that arise more easily, transparency of supply chain, and superior consistency of product batch to batch, and year to year.
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