ANALYTICAL METHOD SOP # S PROCEDURES ERDOSTEINE - …

SOP # S-230-04-0600 ANALYTICAL METHODPROCEDUREST otal Numberof Pages 8. ERDOSTEINE - N0: 04 Effective Date:IAGIMAPPROVED:IAG-SI -10846 ERDOSTEINE 04 ACTIVE DRUG SUBSTANCE MONOGRAPHEd. Status :Supcds 03DD/MM/2000 AnneANALYSTB ellaSUPERVISORE dannaQCCarolHEADSTRUCTURAL FORMULA( 1S-(2-[N-3-(2-oxotetrahydro thienyl)]acetamido)-thioglycolic acid) = :White to ivory whiteAppearance:Microcrystalline powderSOLUBILITYS lightly soluble in methanol, ethanol, acetone, # S-230-04-0600 ANALYTICAL METHODPROCEDUREST otal Numberof Pages 8. ERDOSTEINE - N0: 04 Effective Date:IAGIMAPPROVED:IAG-SI -10846 ERDOSTEINE 04 ACTIVE DRUG SUBSTANCE MONOGRAPHEd. Status :Supcds 03DD/ SpectrumThe infrared spectrum of a nujol homogeneous dispersion of the testmaterial, exhibits maxima only at the same wavelengths as that of a similarpreparation of an ERDOSTEINE retention time of the major peak in the chromatogram of the Samplepreparation corresponds to that of the Standard Preparation, obtained asdirected in the of solutionA test solution ( w/v in Methanol) is clear and colorless, according on dryingDetermined on a sample of about , exactly weighed, in oven at 105 Cup to constant weight, according to USP METHOD <731>.

sop # s-230-04-0600 analytical method procedures total number of pages 8. erdosteine - monograph. ed. n0: 04 effective date: iagim approved: iag-si -10846 erdosteine 04 active drug substance monograph

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