(S)-Lactic Acid 25Ltr
suitable for use as excipient EMPROVE® exp Ph Eur,BP,E 270
Manufacturer: Merck
Catalog ID: 100366.9025
Stock: In Stock
Description
| Catalogue Number | 100366 |
| Synonyms | 2-Hydroxypropionic acid, Lactol |
Product Information
| Grade | Ph Eur,BP,E 270 |
| HS Code | 2918 11 00 |
Physicochemical Information
| Boiling point | 122 °C (20 hPa) |
| Density | 1.21 g/cm3 (20 °C) |
| Melting Point | 18 °C |
| pH value | 2.8 (10 g/l, H₂O, 20 °C) |
| Vapor pressure | 0.1 hPa (25 °C) |
Storage and Shipping Information
| Storage | Store at +5°C to +30°C. |
Specifications
| Assay (alkalimetric) | 88.0 - 92.0 % |
| Assay (stereochemical purity of (S)-lactic acid) | ≥ 95.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (pH) | passes test |
| Identity (Density) | passes test |
| Identity (Lactat) | passes test |
| Identity (assay) | passes test |
| Appearance | clear, oily liquid, not more intense in color than reference solution Y₆ |
| Ether-insoluble substances | passes test |
| Citric, oxalic and Phosphoric acids | passes test |
| Density (d 20/20) | 1.20 - 1.21 |
| Chloride (Cl) | ≤ 0.2 % |
| Sulfate (SO₄) | ≤ 200 ppm |
| As (Arsenic) | ≤ 0.0003 % |
| Ca (Calcium) | ≤ 200 ppm |
| Fe (Iron) | ≤ 0.001 % |
| Hg (Mercury) | ≤ 0.0001 % |
| Pb (Lead) | ≤ 0.0005 % |
| Ethanol | ≤ 5000 ppm |
| Acetic acid | ≤ 5000 ppm |
| Methanol | ≤ 50 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sugars and other reducing substances | passes test |
| Sulfated ash (600 °C) | ≤ 0.10 % |
| 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. | |
| Corresponds to Ph Eur,BP, E 270 Conforms to the purity criteria on food additives according to European Commission directive 2008/84/EC. |
