Saflık (alkalimetrik) | 88.0 - 92.0 % |
Assay (stereochemical purity of (S)-lactic acid) | ≥ 95.0 % |
Özdeşlik (IR-spectrum) | Testi geçer |
Özdeşlik (pH) | Testi geçer |
Özdeşlik (Yoğunluk) | Testi geçer |
Özdeşlik (Lactat) | Testi geçer |
Özdeşlik (assay) | Testi geçer |
Appearance | clear, oily liquid, not more intense in color than reference solution Y₆ |
Ether-inÇözünür substances | Testi geçer |
Citric, oxalic and Phosphoric acids | Testi geçer |
Yoğunluk (d 20/20) | 1.20 - 1.21 |
Chloride (Cl) | ≤ 0.2 % |
Sulfate (SO₄) | ≤ 200 ppm |
As (Arsenic) | ≤ 3 ppm |
Ca (Calcium) | ≤ 200 ppm |
Fe (Iron) | ≤ 10 ppm |
Hg (Mercury) | ≤ 1 ppm |
Pb (Lead) | ≤ 2 ppm |
Ethanol | ≤ 5000 ppm |
Acetic acid | ≤ 5000 ppm |
Methanol | ≤ 50 ppm |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Sugars and other reducing substances | Testi geçer |
Sulfated ash (600 °C) | ≤ 0.10 % |
Total aerobic microbial count (TAMC) | ≤ 10² |
Total combined yeasts/moulds count (TYMC) | ≤ 10² |
Bacterial endotoxins | ≤ 5 I.U./g |
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
Corresponds to Ph Eur,BP, E 270 Conforms to the purity criteria on food additives according to European Commission directive 2008/84/EC. |