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Extractables and Leachable
Regulatory agencies recommend the risk evaluation of all the packaging materials used for the storage of drug products.
Nitrosamines
Nitrosamines are a class of compounds with a chemical structure of a nitroso group bonded to an Amine.
Method Development and Method Validation
We at Itrace are capability to provide services related to analytical development
Glass Delamination
USP general information chapter <1660> Evaluation of the inner surface durability of glass container.
Elemental Impurity Analysis
Elemental analysis requires identification and quantification of elemental composition from trace & ultra-trace levels.
Genotoxic Impurities
Various regulatory agencies in all over the world, require that harmful impurities in drug products be controlled and removed to below regulated limits.
Quality Policy
About Laboratory
On the other hand we denounce with righteous indignation and dislike men who are so beguiled and demoralized by the pleasure of the desire that they cannot foresee.