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L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® exp ChP, BP, Ph. Eur., JP suitable for use as excipient, SAFC®

Supplier: EMD MILLIPORE - PCS - GPS

1.04354.0500 1.04354.9010
EM1.04354.0500EA 1751.16 USD InStock
EM1.04354.0500 EM1.04354.9010
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® exp ChP, BP, Ph. Eur., JP suitable for use as excipient, SAFC®
L(+)-Histidine monohydrochloride monohydrate


Formula: C₆H₉N₃O₂·HCl·H₂O
MW: 209.63 g/mol
Melting Pt: 259 (dec.)
Density: 1.4723 g/cm³ (20 °C)
 MDL Number: MFCD00151027
CAS Number: 5934-29-2
EINECS: 211-438-9
Merck Index: 13,04741
https://qa.digitalassets.avantorsciences.com/adaptivemedia/rendition?id=561d2381f930afe618f78d680790ea9a43f6596c&vid=561d2381f930afe618f78d680790ea9a43f6596c&prid=web&clid=SAPDAM
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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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