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Services |
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| We will be your partners in the Identification, Characterization, Impurity Profiling and Analysis of your products, be it a Pharmaceutical Finished Products, an API or an Intermediate.
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| ENEM offers a full spectrum of services. |
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| Basic Analytical Services |
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Compendial testing as per USP, EP , BP and IP |
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Method development, validation and testing for Non-Compendial products. |
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Residual solvent analysis |
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Comparator testing with RLD |
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Particle Size Characterization – Dry and Wet |
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| Stability |
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Stability storage: Accelerated, Long Term and Intermediate Stability testing |
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Testing of Stability Samples and Trend Analysis |
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| Profiling and Characterization |
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Isolation and purification of Impurities above Identification Threshold by using Combiflash, Prep HPLC |
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Structure Elucidation of API and impurities by using NMR, LC- MS, FTIR and associated instruments |
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| Inhalation Testing* |
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By Laser Diffraction as well as Andersen Impactor |
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| Other Support Services* |
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Synthesis of standards and Impurities |
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Formulation Development Projects |
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DMF Filing in eCTD format |
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Audit Services |
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| WE OFFER ALL THE ABOVE SERVICES FOR BOTH THE EU, US AS WELL AS LATIN AMERICAN, AFRICAN AND ASIAN MARKETS |
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| *Will be managed by us, but provided through other divisions of our organization. |
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