Sodium Lactate Injection Grade
Test Standard: Dir2008/84/EC&Amendments USP31 EP6
Item Standard Road-Test standard
Appearance Pass EP Test Pass EP Test
Sodium lactate test Pass EP Test Pass EP Test
Sodium test Pass EP Test Pass EP Test
Color(Fresh Solution) ≤50Hazen 17
Density at 20℃ 1.32-1.34g/ml 1.32-1.34g/ml
Sodium lactate content 60-61 60.4
Sodium content 12.3-12.6%w/w 12.4%w/w
Total acid(As lactic acid) Max.0.3%w/w 0.04%w/w
Stereo chemical purity(L-isomer) ≥97% ≥97%
pH(Fresh Solution) 6.5-8.5 8.3
pH(Thermostability) Max.0.2(Heatstable)Max.0.2(Heatstable)
Iron Max.5ppm Max.5ppm
Chloride Max.25ppm Max.25ppm
Calcium Max.10ppm Max.10ppm
Sulphate Max.20ppm Max.20ppm
Heavy metals total Max.5ppm Max.5ppm
Arsenate Max.1ppm Max.1ppm
Mercury Max.1ppm Max.1ppm
Barium Pass EP Test Pass EP Test
Aluminum Max.0.1ppm Max.0.1ppm
Lead Max.5ppm Max.5ppm
Reducing Substances sugars&sucroses Pass EP test Pass EP test
Reducing Substances(sugars) Pass USP test Pass USP test
Oxalate/Phosphate Pass EP test Pass EP test
Citrate/Oxalate/Phosphate/ Tartrate Pass USP test Pass USP test
Methanol and methyl esters Max.25ppm Max.25ppm
Ethanol Max.150ppm Max.150ppm
Bacterial endotoxins Max.5 IU/g. Max.5 IU/g.
Microbial contamination Max.10 cfu/g Max.10 cfu/g
Mesophilic bacteria Max.100 counts/g Max.100 counts/g
Moulds Max.10 counts/g Max.10 counts/g
Yeasts Max.100 counts/g Max.100 counts/g
Package: 25KG/Plastic Drum
Uses:
It is used as a constituent of dialysis solution in Ringer's lactate solutions and as an alkalisation agent for the treatment of acidoses.