Products Specifications

Compound Sodium Lactate Injection B.P.
Test Characteristics Identification (A, B & C) Acidity or alkalinity PH Particulate Contamination Test of Sterility Bactrial endotoxins Extractable volume Assay (i) Content of sodium (ii) Content of Potassium (iii) Content of total chloride (iv) Content of calcium chloride (v) Content of lactate, calculated as c3 H6 O3	Specification A Clear colour less solution Should comply BP 1999 Between 5.0 & 7.0 Should comply BP 1999 Should comply BP 1999 Should comply BP 1999 (Endotoxin limit NMT 0.25 IU/ml) Between -500ml&510ml 0.27% to 0.32% w/v 0.019% to 0.022% w/v 0.37% to 0.42% w/v 0.025% to 0.029% w/v 0.23% to 0.28% w/v
Metronidazole Injection I.P. (0.5% W/V)
Test Description Identification PH Bacterial Endotoxin test Extractable volume Particulate Matter Sterility Assay	Specification Clear, colourless to pale yellow solution Should comply IP 1996 Between 4.5 & 7.0 Not more then 0.35 mg of Metroidazole Between -100 & 104 Should comply IP 1996 Should comply IP 1996 Not less then 90% and not be more then 110%
Metronidazole Injection USP (0.5% W/V)
Test Description Identification PH Bacterial Endotoxin test Extractable volume Particulate Matter Sterility Assay	Specification Clear, colourless to pale yellow solution Should comply USP 24 Between 4.5 & 7.0 Not more then 0.35 mg of Metroidazole Between -100 & 104 Should comply USP 24 Should comply USP 24 Not less then 90% and not be more then 110%
Ciprofloxacin Injection IP (0.2% W/V)
Test Description Identification PH Particulate Matter Limit of ciprofloxacin ethylenediamine analog  Lactic acid content Extractable volume Sodium chloride content Test for Sterility Bacterial Endotoxin test Assay	Specification A Clear colourless solution Should comply IP 1996 Between 3.5 & 4.6 Should comply IP 1996 Should comply IP 1996 (Limit: N.M.T. 0.5%) Between 0.288mg & 0.352mg of Lactic acid/mg of Ciprofloxacin Between 100ml & 104ml Between 0.855 & 0.945gper 100ml Should meet the requirment of IP 1996 (Using membrane Filtration method) Should comply IP 1996 (Not more then 0.25 EU/mg of Ciprofloxacin) Not less then 90% & not be more then 110% of Labled Claim of Ciprofloxacin
Ciprofloxacin Injection USP (0.2% W/V)
Test Description Identification PH Particulate Matter Limit of ciprofloxacin ethylenediamine analog  Lactic acid content Extractable volume Sodium chloride content Test for Sterility Pyrogen (Dose 20 mg of Ciprofloxacin/kg of Rabbit weight) Assay	Specification A Clear colourless solution Should comply USP 24 Between 3.5 & 4.6 Should comply USP 24 Should comply USP 24 (Limit: N.M.T. 0.5%) Between 0.288mg & 0.352mg of Lactic acid/mg of Ciprofloxacin Between 100ml & 104ml Between 0.855 & 0.945g per 100ml. Should meet the requirment of USP 24 (Using membrane Filtration method) Should comply USP 24 Not less then 90% & not more then 110% of Labled Claim of Ciprofloxacin
Multiple Electrolyte & Dextrose Injection Type 3 USP
Test Description Identification (A, B & C) PH Particulate Matter Test for Sterility Bactrial endotoxine Extractable volume Assay (i) Content of sodium (ii) Content of potassium (iii) Content of Total chloride (iv) Content of Dextrose	Specification Clear colourless to pale yellow solution Should comply USP 24 Between 4.0 & 6.5 Should comply USP 24 Should comply USP 24 Should comply USP 24 (Endotoxin limit NMT 0.5 EU/ml) Between 500ml & 510ml 79.38 mg to 97.02 mg/100 ml 123.3 mg to 150.7 mg/100 ml 0.1143 mg to 0.1524 mg/100 ml 4.5 mg to 5.25 mg/100 ml
Multiple Electrolyte & Dextrose Injection Type 1USP
Test Description Identification (A, B & C) PH Particulate Matter Test for Sterility Bactrial endotoxine Extractable volume Assay (i) Content of sodium (ii) Content of potassium (iii) Content of Total chloride (iv) Content of Dextrose (v) Content of Magnesium Chloride	Specification Clear colourless to pale yellow solution Should comply USP 24 Between 4.0 & 6.5 Should comply USP 24 Should comply USP 24 Should comply USP 24 (Endotoxin limit NMT 0.5 EU/ml) Between 500ml & 510ml 53.24 mg to 65.07 mg/100 ml 66.6 mg to 81.4 mg/100 ml 0.07089 mg to 0.0945 mg/100 ml 4.5 mg to 5.25 mg/100 ml 0.0279 mg to 0.0341 mg/100 ml

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