L-Isoleucine Emprove 100gm
EMPROVE® ESSENTIAL Ph Eur,USP
Manufacturer: Merck
Catalog ID: 105357.0100
Stock: In Stock
Description
| Catalogue Number | 105357 |
| Synonyms | iso-Leucine, Ile |
Product Information
| CAS number | 73-32-5 |
| EC number | 200-798-2 |
| Grade | Ph Eur,USP |
| Hill Formula | C₆H₁₃NO₂ |
| Molar Mass | 131.17 g/mol |
| HS Code | 2922 49 85 |
Physicochemical Information
| Melting Point | 279 - 280 °C (decomposition) |
| pH value | 5.5 - 6.5 (40 g/l, H₂O, 20 °C) |
| Bulk density | 470 kg/m3 |
| Solubility | 40 g/l |
Storage and Shipping Information
| Storage | Store at +5°C to +30°C. |
Specifications
| Assay (perchloric acid titration, calculated on dried substance) | 98.5 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white, crystalline powder or flakes |
| Appearance of solution (50 g/l, hydrochloric acid 1 mol/l) | clear and not more intense in color than reference solution BY₆ |
| Spec. rotation (α 20/D, 40 g/l, Hydrochloric acid 250 g/l, calc. on dried substance) | +40.0 to +43.0 |
| Spec. rotation (α 25/D, 40 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +38.9 to +41.8 |
| pH (10 g/l, CO₂-free water) | 5.5 - 7.0 |
| Chloride (Cl) | ≤ 200 ppm |
| Sulfate (SO₄) | ≤ 300 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Fe (Iron) | ≤ 10 ppm |
| Fe (Iron) (ICP) | ≤ 10 ppm |
| Mn (Manganese) | ≤ 25 ppm |
| Related substances (TLC) | ≤ 0.5 % |
| Related compounds (HPLC) (Leucine) | ≤ 0.5 % |
| Related compounds (HPLC) (any unspecified impurity) | ≤ 0.2 % |
| Related compounds (HPLC) (total unspecified impurities) | ≤ 1.0 % |
| Ninhydrin-positive substances (LC) (impurity A (570 nm)) | ≤ 0.3 % |
| Ninhydrin-positive substances (LC) (impurity C (570 nm)) | ≤ 0.3 % |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) | ≤ 0.2 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) | ≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) | ≤ 1.0 % |
| Methanol (HS-GC) | ≤ 3000 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (105 °C; 3 h) | ≤ 0.3 % |
| 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., USP. |
