if out of two set of results of moisture analysis first 1 is passing, second one is failing, is it oos ? or vice a versa first 1 is failing and second one is passing. for information mean value to be reported and in mean value the substance is ppassing, is it oos or normaal mean value to be considered?
Answer / vali
mean value should be consider pass from each passed trial. if any trial fails it should report as OOS
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Why we are having specification 100% above in case of assay as there is only 100% of compound?
2 Answers MSN Pharma, Nectar Lifesciences,
Dear Sir, This is Thirunavukkarasu am working in Ordain Health Care AR&D, Am Having one problem While doing method development my question Metadoxine and Pyridoxine same chemical nature and structural activity i tried lot of methods but Analyte eluted same Retantion time i cant separate both peaks. solubility, pH both are same only only difference melting point metadoxine 210 C Pyridoxine 102 C please do the help needful for me
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