L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
Supplier: MilliporeSigma
1.04354.0500
1.04354.9010
EM1.04354.0500EA
1913.74
USD
EM1.04354.0500
EM1.04354.9010
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
L(+)-Histidine monohydrochloride monohydrate
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Formula:
C₆H₉N₃O₂·HCl·H₂O Melting Pt: 259 °C (dec.) Density: 1.4723 g/cm³ (20 °C) |
MDL Number:
MFCD00151027 CAS Number: 5934-29-2 EINECS: 211-438-9 |
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Specification Test Results
| 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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