L (+)-Histidine-monohydroklorid-monohydrat 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., BP, JP suitable for use as excipient, SAFC®
Leverantör: MERCK PRODUCTION CHEMICALS
Synonyms:
L-Histidine monohydrochloride monohydrate, (2S)-(+)-Histidine monohydrochloride monohydrate, L-Histidine hydrochloride monohydrate, (S)-(+)-Histidine monohydrochloride monohydrate, His HCl monohydrate, H-His-OH.HCl.H2O, H-His-OH·HCl·H₂O, L-3-Imidazol-4-ylalanine monohydrochloride monohydrate, L-Histidine hydrochloride hydrate
1.04354.0500
1.04354.9010
1.04354.0500EA
17875
SEK
1.04354.0500
1.04354.9010
L (+)-Histidine-monohydroklorid-monohydrat 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., BP, JP suitable for use as excipient, SAFC®
L (+)-Histidine-monohydroklorid-monohydrat
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Formel:
C₆H₉N₃O₂·HCl·H₂O MW: 209,63 g/mol Smältpunkt: 259 °C (dec.) Densitet: 1,4723 g/cm³ (20 °C) Storage Temperature: Omgivande |
MDL Number:
MFCD00151027 CAS nummer: 5934-29-2 EINECS: 211-438-9 Merck Index: 13,04741 |
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Specifikation testresultat
| 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 |
| Sulfate (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 % |
| Bacterial endotoxins | ≤ 20 I.U./g |
| Microbiological test (total aerobic microbial count (TAMC)) | ≤ 10² |
| Microbiological test (total yeast and mould count (TYMC)) | ≤ 10¹ |
| 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 |
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