Potassium dihydrogen phosphate - PDF document

HiMedia Laboratories Technical Data Please refer disclaimer Overleaf. Preparation of test strain Escherichia coli ATCC50 -100 no decrease incolony count no decrease in no decrease in(stored at Escherichia coli ATCC 50 -100 no decrease in no decrease in no decrease in Escherichia coli NCTC 9002 50 -100 no decrease in no decrease in no decrease in Staphylococcus aureus 50 -100 no decrease in no decrease in no decrease in 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Salmonella Typhimurium 50 -100 no decrease in no decrease in no decrease in Growth Promotion Test/IP).Cultural response Cultural ResponseOrganism Inoculum Recovery Recovery Recovery of incubation 7.00 Quality ControlAppearanceWhite to cream homogeneous free flowing powder Colour and Clarity of prepared mediumColourless clear solution wany precipitate pH Salmonella Abony NCTC 50 -100 no decrease incolony count no decrease in no decrease in Bacillus subtilis 50 -100 no decrease in no decrease in no decrease in Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh Hn Uisro ciafnossib usd onky. Rdac shd bdeord opdninf sbnpmespmmpx bppsppsibue uecioirues fps ibodmioh HiMedia Laboratories Technical Data . British Pharmacopoeia, 201 The Stationery office British Pharmacopoeia . European Pharmacopoeia, 201, European Dept. for the quality of Medicines. . Japanese Pharmacopoeia, 20. . Indian Pharmacopoeia, 201, Govt. of India, the controller of Publication, Delhi, India. Revision : / 201 Reference . The United States Pharmacopoeia, 201 The United States Pharmacopoeial Convention. Rockville, MD. 2-8°C) Micrococcus luteus ATCC9341 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 10231 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 2091 50 -100 no decrease in no decrease in no decrease in shd procubs. shd procubs Tsd bdeord dxpiry casd on shd kabdk Uses nusu eosuse sbfe disppsbm by buupcmbwioh bod/ps iocioesbuipo pf used ps uousbbme psepbsbuipos pf uiis pspducu. Fpmmpx esubbmisied mbbpsbupsy pspceduses io disppsioh pf iofecuipus nbuesibms nusu be decpoubniobued bod disppsed pf io bccpsdboce Orobdcurds Gancbooj. 1 Please refer disclaimer Overleaf. HiMedia Laboratories User must ensure suitability of the product(s) in their application prior to use. Products conform solely to the information contained inthis and other related HiMedia™ publications. The information contained in this publication is based on our research and developmentwork and is to the best of our knowledge true and accurate. HiMedia™ Laboratories Pvt Ltd reserves the right to make changes tospecifications and information related to the products at any time. Products are not intended for human or animal or therapeutic use butfor laboratory,diagnostic, research or further manufacturing use only, unless otherwise specified. Statements contained herein should not In vitro diagnostic medicalCE Markingnot use if package is ,Esdoornlaan 13, 3951 IVD 23 Vbdiboi Iodususibm Esubue, HiMedia Laboratories Technical Data . British Pharmacopoeia, 201 The Stationery office British Pharmacopoeia . European Pharmacopoeia, 201, European Dept. for the quality of Medicines. . Japanese Pharmacopoeia, 20. . Indian Pharmacopoeia, 201, Govt. of India, the controller of Publication, Delhi, India. Revision : / 201 Reference . The United States Pharmacopoeia, 201 The United States Pharmacopoeial Convention. Rockville, MD. 2-8°C) Micrococcus luteus ATCC9341 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 10231 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 2091 50 -100 no decrease in no decrease in no decrease in shd kabdk. eormasion cud shd hyfrosbopib cry udnsikasdc Tsd bdeord dxpiry casd on shd kabdk Uses nusu eosuse sbfe disppsbm by buupcmbwioh bod/ps iocioesbuipo pf used ps uousbbme psepbsbuipos pf uiis pspducu. Fpmmpx esubbmisied mbbpsbupsy pspceduses io disppsioh pf iofecuipus nbuesibms nusu be decpoubniobued bod disppsed pf io bccpsdboce Orobdcurds Gancbooj. 1 Please refer disclaimer Overleaf. HiMedia Laboratories Technical Data Please refer disclaimer Overleaf. Preparation of test strain Escherichia coli ATCC50 -100 no decrease incolony count no decrease in no decrease in(stored at Escherichia coli ATCC 50 -100 no decrease in no decrease in no decrease in Escherichia coli NCTC 9002 50 -100 no decrease in no decrease in no decrease in Staphylococcus aureus 50 -100 no decrease in no decrease in no decrease in 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Salmonella Typhimurium 50 -100 no decrease in no decrease in no decrease in Growth Promotion TestGrowth Promotion is carried out in accordance with the harmonized method of ICH(USP/EP/BP/JP/IP). Cultural characteristics observed after recovery on Soybean Casein Digest Agar after an incubation at 30-35°C for 18-24 Cultural ResponseOrganism Inoculum(CFU) Recovery Recovery Recovery of incubation 7.00 Quality ControlAppearanceWhite to cream homogeneous free flowing powder Colour and Clarity of prepared mediumColourless clear solution wany precipitate pH Odreormanbd oe shd mdcium is dxpdbsdc whdn usdc as pdr shd cirdbsion on shd kabdk wishin shd dxpiry pdrioc whdn ssordc as Salmonella Abony NCTC 50 -100 no decrease incolony count no decrease in no decrease in Bacillus subtilis 50 -100 no decrease in no decrease in no decrease in Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation fooc bueedrinf anc akso sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh opdninf shd eabd prosdbsion. prdbausions as Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation fooc bueedrinf anc akso sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh opdninf shd eabd prosdbsion. prdbausions as Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation fooc bueedrinf anc akso sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh opdninf shd eabd prosdbsion. prdbausions as Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation fooc bueedrinfanc akso sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh opdninf shd eabd prosdbsion. prdbausions as Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation sdss ssrain **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh opdninf shd eabd prosdbsion. prdbausions as Buffered Sodium Chloride-Peptone Solution pH 7.0 MH1275 ecommended as a diluent for carrying out microbial limit testingby harmonized methodology of pharmaceutical products in accordance with USP/EP/BP/JP/IP.Composition** Ingredients Gms / Litre Potassium dihydrogen phosphate 3.600 Disodium hydrogen phosphate dihydrate 7.200 Sodium chloride 4.300 Peptone 1.000 Final pH ( at 25°C) in tube or flask DirectionsSuspend 14.64 grams (the equivalent weight of dehydrated medium per litre) in 1000 ml purified /distilled water. Heat ifnecessary to dissolve the medium completely. For preparation of nonfatty products insoluble in water, add 0.1% w/v Polysorbate 80 to assist the suspension of poorly wettable substances. Dispense in tubes or flasks and sterilize by autoclaving at 15 lbs pressure 121°C for 15 minutes or as per validated cycle. Principle And Interpretation fooc bueedrinf anc akso **Formula adjusted, standardized to suit performance parametersPeptone (meat or casein) pmmpx bppsppsibue uecioirues fps ibodmioh pmmpx bppsppsibue uecioirues fps ibodmioh eabd prosdbsion. HiMedia Laboratories Technical Data Please refer disclaimer Overleaf. Preparation of test strain Escherichia coli ATCC50 -100 no decrease incolony count no decrease in no decrease in(stored at Escherichia coli ATCC 50 -100 no decrease in no decrease in no decrease in Escherichia coli NCTC 9002 50 -100 no decrease in no decrease in no decrease in Staphylococcus aureus 50 -100 no decrease in no decrease in no decrease in 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Salmonella Typhimurium 50 -100 no decrease in no decrease in no decrease in Growth Promotion TestGrowth Promotion is carried out in accordance with the harmonized method of ICH(USP/EP/BP/JP/IP). Cultural characteristics observed after recovery on Soybean Casein Digest Agar after an incubation at 30-35°C for 18-24 Cultural ResponseOrganism Inoculum(CFU) Recovery Recovery Recovery of incubation 7.00 Quality ControlAppearanceWhite to cream homogeneous free flowing powder Colour and Clarity of prepared mediumColourless clear solution wany precipitate pH Odreormanbd oe shd mdcium is dxpdbsdc whdn usdc as pdr shd cirdbsion on shd kabdk wishin shd dxpiry pdrioc whdn ssordc as Salmonella Abony NCTC 50 -100 no decrease incolony count no decrease in no decrease in Bacillus subtilis 50 -100 no decrease in no decrease in no decrease in HiMedia Laboratories Technical Data Please refer disclaimer Overleaf. Preparation of test strain Escherichia coli ATCC50 -100 no decrease incolony count no decrease in no decrease in(stored at Escherichia coli ATCC 50 -100 no decrease in no decrease in no decrease in Escherichia coli NCTC 9002 50 -100 no decrease in no decrease in no decrease in Staphylococcus aureus 50 -100 no decrease in no decrease in no decrease in 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Salmonella Typhimurium 50 -100 no decrease in no decrease in no decrease in Growth Promotion Test/IP). Cultural characteristics observed after recovery on Soybean Casein Digest Agar after an incubation at 30-35°C for 18-24 Organism Inoculum Recovery Recovery Recovery of incubation 7.00 Quality ControlAppearanceWhite to cream homogeneous free flowing powder Colour and Clarity of prepared mediumColourless clear solution wany precipitate pH Odreormanbd oe shd mdcium is dxpdbsdc whdn usdc as pdr shd cirdbsion on shd kabdk wishin shd dxpiry pdrioc whdn ssordc as Salmonella Abony NCTC 50 -100 no decrease incolony count no decrease in no decrease in Bacillus subtilis 50 -100 no decrease in no decrease in no decrease in HiMedia Laboratories User must ensure suitability of the product(s) in their application prior to use. Products conform solely to the information contained inthis and other related HiMedia™ publications. The information contained in this publication is based on our research and developmentwork and is to the best of our knowledge true and accurate. HiMedia™ Laboratories Pvt Ltd reserves the right to make changes tospecifications and information related to the products at any time. Products are not intended for human or animal or therapeutic use butfor laboratory,diagnostic, research or further manufacturing use only, unless otherwise specified. Statements contained herein should not In vitro diagnostic medicalCE Markingnot use if package is ,Esdoornlaan 13, 3951 IVD 23 Vbdiboi Iodususibm Esubue, HiMedia Laboratories Pvt. Ltd. Reg.office : 23, Vadhani Ind.Est., LBS Marg, Mumbai-400086, Customer care No.: 022-6116 office : A-516,Swastik Disha Business Park,Via Vadhani Ind. Est., LBS Marg, Mumbai-400086, India. Customer care No.: 022-6147 1919 Email: HiMedia Laboratories Technical Data . British Pharmacopoeia, 201 The Stationery office British Pharmacopoeia . European Pharmacopoeia, 201, European Dept. for the quality of Medicines. . Japanese Pharmacopoeia, 20. . Indian Pharmacopoeia, 201, Govt. of India, the controller of Publication, Delhi, India. Revision : / 201 Reference . The United States Pharmacopoeia, 201 The United States Pharmacopoeial Convention. Rockville, MD. 2-8°C) Micrococcus luteus ATCC9341 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 10231 50 -100 no decrease in no decrease in no decrease in Candida albicans ATCC 2091 50 -100 no decrease in no decrease in no decrease in opdninf, procubs shd procubs. shd procubs Uses nusu eosuse sbfe disppsbm by buupcmbwioh bod/ps iocioesbuipo pf used ps uousbbme psepbsbuipos pf uiis pspducu. Fpmmpx esubbmisied mbbpsbupsy pspceduses io disppsioh pf iofecuipus nbuesibms nusu be decpoubniobued bod disppsed pf io bccpsdboce Orobdcurds Gancbooj. 1 Please refer disclaimer Overleaf. HiMedia Laboratories Technical Data Please refer disclaimer Overleaf. Preparation of test strain Escherichia coli ATCC50 -100 no decrease incolony count no decrease in no decrease in(stored at Escherichia coli ATCC 50 -100 no decrease in no decrease in no decrease in Escherichia coli NCTC 9002 50 -100 no decrease in no decrease in no decrease in Staphylococcus aureus 50 -100 no decrease in no decrease in no decrease in 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Pseudomonas aeruginosa 50 -100 no decrease in no decrease in no decrease in Salmonella 50 -100 no decrease in no decrease in no decrease in Growth Promotion Test/IP). Cultural characteristics observed after recovery on Soybean Casein Digest Agar after an incubation at 30-35°C for 18-24 Organism Inoculum(CFU) Recoverywithin 2 hours Recovery Recovery of incubation 7.00 Quality ControlAppearanceWhite to cream homogeneous free flowing powder Colour and Clarity of prepared mediumColourless clear solution wany precipitate pH Odreormanbd oe shd mdcium is dxpdbsdc whdn usdc as pdr shd cirdbsion on shd kabdk wishin shd dxpiry pdrioc whdn ssordc as Salmonella NCTC 50 -100 no decrease incolony count no decrease in no decrease in Bacillus subtilis 50 -100 no decrease in no decrease in no decrease in