Listing ID #392247
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Grades | IP | BP | USP | EP | JP |
Alkalinity/Acidity | 0.5 ml of 0.01 M HCl/ 0.5 ml of 0.01 M NaOH | 0.5 ml of 0.01 M HCl/ 0.5 ml of 0.01 M NaOH | Complies to prescribed limit test | 0.5 ml of 0.01 M HCl/ 0.5 ml of 0.01 M NaOH | 0.5 ml of 0.01 M HCl/ 0.5 ml of 0.01 M NaOH |
Arsenic | Max 1 ppm | - | - | - | Not more than 2 ppm |
Barium | No opalescence | No opalescence | Max. 0.1% | No opalescence | - |
Iron | Max 20 ppm | Max 20 ppm | - | Max 20 ppm | No Red-purple colour |
Heavy Metals | Max 10 ppm | Max 10 ppm | Max. 0.001% | Max 10 ppm | Max 5 ppm |
Clarity of Solution | Clear & colourless | Clear & colourless | Clear & Colorless | Clear & colourless | Clear & colourless |
Magnesium & alkaline-earth metals | Solution remains clear | Max. 200 ppm | No Turbidity for 5 min. | Max. 200 ppm | No Turbidity in 5 min |
Bromide | Max 0.1% | Max 0.1% | Max. 0.1 % | Max 0.1% | No Yellow Colour |
Iodide | No blue colour | No blue colour | 0.05% | No blue colour | No blue colour |
Sulphate | 300 ppm Max. | 300 ppm Max. | - | 300 ppm Max. | - |
Organic Volatile Impurities | - | - | Meets Requirements | - | - |
Loss on drying | Max 1.0% | Max. 1.0 % @ 105oC for 3 hours | Max. 1.0 % @ 105oC for 3 hours | Max. 1.0 % @ 105oC for 3 hours | Max. 0.5 % @ 130oC for 2 hours |
Assay Dry Basis | 99.0 % to 100.5 % | 99.0 % to 100.5 % | 99.0 % to 100.5 % | 99.0 % to 100.5 % | Not less than 99.0 % |
Additional parameters for Dialysis grade | |||||
Aluminium | 1 ppm Max. | 1 ppm Max. | Max. 1 μg/gm | 1 ppm Max. | - |
Additional parameters for Inject-able grade | |||||
Sodium | 0.1% Maximum | 0.1% Maximum | No yellow color flame | 0.1% Maximum | No yellow colour |
pH | - | 4.5-8.0 | 4.0-8.0 | - | - |
Bacterial Endotoxins | - | - | 8.80 EU/MEq | - | - |