I’ve only read the highlights of this - in the process of getting the full version.
Could be interesting reading…
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Finally published in the June issue of Journal of Pharmaceutical Sciencies
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A new LC-MS/MS method was developed and validated for the detection of nitrosamine impurities in different combined finished products containing sartan group and alu-foil packaging.
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Different packaging components were studied within the scope of the Extractables&Leachables study to evaluate the possibility of leaching not only from tablet blisters but also from different pharmaceutical packaging components and ink printed labels.
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Validation parameters and acceptance criteria were determined in accordance with USP 〈736〉 mass spectrometry monograph and ICH Q2 (R2) guide.
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Packaging components (such as canister, blister, printed aluminum foil, nasal spray, and eye drop packaging materials) were checked in accordance with risk assessment studies carried out in line with the ICH Q9 guide.
Abstract:
The detection of nitrosamine impurities, particularly small dialkyl types, which are frequently known to be potent mutagenic carcinogens, in some Sartan group active pharmaceutical ingredients (APIs) and finished drug products caused global regulatory organizations to have concerns. Accordingly, Registration Holders/Applicants, API manufacturers, and their raw material suppliers are required to check the presence of nitrosamines in their products and carry out risk assessments using the quality risk management principles specified in the ICH Q9 guide. In this context, a new LC-MS/MS method has been developed and validated for the simultaneous determination of NDMA, NDEA, NMBA, NDIPA, NEIPA, NDBA, and MeNP nitrosamine compounds in API and finished products as well as in primary packaging materials, one of the risk sources. This validated method was applied to check the nitrosamine content may occur from canister, blister, printed aluminum foil, nasal spray, and eye drop packaging materials as part of the Extractables & Leachables studies arising from interactions between the product and the primary packaging. For the determination and quality control of nitrosamines in sartan group pharmaceutical products and packaging materials, the developed LC-MS/MS analytical method offers highly reliable, fast, high accuracy, good sensitivity and simultaneous detection even at low concentrations.