L(+)-Histidine 99,0-101,0 Perchloric acid titration, EMPROVE® EXPERT USP, JP, Ph. Eur. suitable for use as excipient, SAFC®
Marques : MERCK PRODUCTION CHEMICALS
Ratings:
Ecrire un avis
Total Evaluation: 0
Moyenne des Notes : 0.0 sur 5
Synonyme(s):
H, (S)-(+)-Histidine, His, H-His-OH
1.04352.1000
1.04352.9010
1.04352.1000EA
1750
EUR
1.04352.1000
1.04352.9010
L(+)-Histidine 99,0-101,0 Perchloric acid titration, EMPROVE® EXPERT USP, JP, Ph. Eur. suitable for use as excipient, SAFC®
L(+)-Histidine
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Formule:
C₆H₉N₃O₂ Poids moléculaire: 155.16 g/mol Point de fusion: 272…273 °C Densité: 1.44 g/cm³ (20 °C) Température de stockage: Température ambiante |
Numéro MDL:
MFCD00064315 Numéro CAS: 71-00-1 EINECS: 200-745-3 Indice Merck: 13,04741 |
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Résultats des tests de spécification
| Assay (acidimetric, calculated on dried substance) | 98.5 - 101.0 % |
| Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white fine-crystalline powder or colorless crystals |
| Appearance of solution (50 g/l; water) | clear and not more intense in color than reference solution BY₇. |
| Appearance of solution (20 g/l, water) | clear and colorless |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance) | +11.4 to +12.4 |
| Spec. rotation (α 25/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +12.6 to +14.0 |
| Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +11,8° to +12,8° |
| pH (20 g/l, CO₂-free water) | 7.0 - 8.5 |
| Chloride (Cl) | ≤ 200 ppm |
| Sulfate (SO₄) | ≤ 200 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| Cu(Copper) | ≤ 25 ppm |
| Fe (Iron) | ≤ 10 ppm |
| Fe (Iron) (ICP) | ≤ 10 ppm |
| Mn (Manganese) | ≤ 25 ppm |
| Zn (Zinc) | ≤ 130 ppm |
| Related Compounds, total (TLC) | ≤ 0.5 % |
| 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 (105 °C; 3 h) | ≤ 0.2 % |
| Bacterial endotoxins | < 2.0 |
| Microbiological test (total aerobic microbial count (TAMC)) | ≤ 10² |
| Microbiological test (total yeast and mould count (TYMC)) | ≤ 10² |
| 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., JP, USP |
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