L-Histidine Monohydrochloride 500Grm
suitable for use as excipient EMPROVE® exp Ph Eur,BP,JP
Manufacturer: Merck
Catalog ID: 104354.0500
Stock: In Stock
Description
| Catalogue Number | 104354 |
| Synonyms | His |
Product Information
| CAS number | 5934-29-2 |
| EC number | 211-438-9 |
| Grade | Ph Eur,BP,JP |
| Hill Formula | C₆H₁₀ClN₃O₂ * H₂O |
| Molar Mass | 209.63 g/mol |
| HS Code | 2933 29 90 |
Physicochemical Information
| Density | 1.49 g/cm3 (20 °C) |
| Melting Point | 259 °C (decomposition) |
| pH value | 3.5 - 4.5 (100 g/l, H₂O, 20 °C) |
| Bulk density | 770 kg/m3 |
| Solubility | 169.9 g/l |
Storage and Shipping Information
| Storage | Store at +5°C to +30°C. |
Specifications
| Assay (alkalimetric, calculated on dried substance) | 98.5 - 101.0 % |
| Assay (Perchloric acid titration, calc. on anhydrous substance) | 99.0 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (Chloride) | passes test |
| Appearance | white to almost white crystalline powder or colorless crystals |
| Appearance of solution (50 g/l CO₂-free water) | clear and not more intense in color than reference solution BY₆ |
| Appearance of solution (100 g/l, CO₂-free water) | clear and colorless |
| pH (50 g/l CO₂-free water) | 3.0 - 5.0 |
| pH (100 g/l, CO₂-free water) | 3.5 - 4.5 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance) | +9.2 to +10.6 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance) | +9.2 to +10.6 |
| Sulphate (SO₄) | ≤ 200 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Fe (Iron) | ≤ 10 ppm |
| Related substances (TLC) | passes test |
| 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) | ≤ 0.5 % |
| Residual solvents (ICH (Q3C)) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (150 °C) | 7.0 - 10.0 % |
| Water (according to Karl Fischer) | 7.2 - 10.0 % |
| 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, JP |
