L-Asparagine Monohydrate 1kg
suitable for use as excipient EMPROVE® exp Ph Eur
Manufacturer: Merck
Catalog ID: 101565.1000
Stock: In Stock
Description
| Catalogue Number | 101565 |
| Synonyms | Asparaginic acid semiamide, Asn |
Product Information
| CAS number | 5794-13-8 |
| EC number | 200-735-9 |
| Grade | Ph Eur |
| Hill Formula | C₄H₈N₂O₃ * H₂O |
| Molar Mass | 150.14 g/mol |
| HS Code | 2924 19 00 |
Physicochemical Information
| Melting Point | 215 - 217 °C decomposes |
| pH value | 4.0 - 5.5 (20 g/l, H₂O, 20 °C) |
| Bulk density | 530 kg/m3 |
| Solubility | 22 g/l |
Storage and Shipping Information
| Storage | Store at +5°C to +30°C. |
Specifications
| Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white crystalline powder or colorless crystals |
| Appearance of solution (20 g/l, CO₂-free water) | clear and colorless |
| Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance) | +33.7 to +36.0 |
| pH (20 g/l, CO₂-free water) | 4.0 - 6.0 |
| Chloride (Cl) | ≤ 200 ppm |
| Sulphate (SO₄) | ≤ 200 ppm |
| Fe (Iron) | ≤ 10 ppm |
| NH₄ (Ammonium) | ≤ 0.1 % |
| Aspartic acid | ≤ 0.5 % |
| Ninhydrin - positive substances (TLC) (Glutamic acid) | ≤ 0.5 % |
| Ninhydrin - positive substances (TLC) (any other impurity) | ≤ 0.5 % |
| Ethanol (HS-GC) | ≤ 5000 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (130 °C, 3 h) | 10.5 - 12.5 % |
| Bacterial endotoxins | ≤ 3.0 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. |
