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4.05 Microbiological Examination of Non-sterile Products

4.05 Microbiological Examination of Non-sterile Products

4.05 Microbiological Examination of Non-sterile Products

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Reinforced medium for ClostridiaBeef extract10.0 gPeptone10.0 gYeast extract3.0 gSoluble starch1.0 gGlucose monohydrate5.0 gCysteine hydrochloride0.5 gSodium chloride5.0 gSodium acetate3.0 gAgar0.5 gPurified water1000 mLHydrate the agar, dissolve by heating to boiling with continuous stirring. If necessary,adjust the pH so that after sterilization it is about 6.8±0.2 at 25°C. Sterilize in an autoclaveusing a validated cycle.Columbia agarPancreatic digest <strong>of</strong> casein10.0 gMeat peptic digest5.0 gHeart pancreatic digest3.0 gYeast extract5.0 gCorn starch1.0 gSodium chloride5.0 gAgar, according to gelling power10.0 g to 15.0 gPurified water1000 mLHydrate the agar, dissolve by heating to boiling with continuous stirring. If necessary,adjust the pH so that after sterilization it is 7.3±0.2 at 25°C. Sterilize in an autoclave using avalidated cycle. Allow to cool to 45 – 50°C; add, where necessary, gentamicin sulfatecorresponding to 20 mg <strong>of</strong> gentamicin base and pour into Petri dishes.16/29

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