Protein synthesis steps

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  describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. 2. SPECIFICITY

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• Protein Synthesis

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  substance, impurities arising from the synthesis of the drug substance, excipients and impurities arising from the excipients), these peaks should be labeled in the chromatograms and their origin(s) discussed in the validation documentation. The quantitation limit for the analytical procedure should be not more than (≤) the reporting threshold.

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