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

Supplier: 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 1310 GBP
1.04354.0500 1.04354.9010
L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP suitable for use as excipient, SAFC®
L(+)-Histidine monohydrochloride monohydrate
Formula: C₆H₉N₃O₂·HCl·H₂O
MW: 209,63 g/mol
Melting Pt: 259 °C (dec.)
Density: 1,4723 g/cm³ (20 °C)
Storage Temperature: Ambient
MDL Number: MFCD00151027
CAS Number: 5934-29-2
EINECS: 211-438-9
Merck Index: 13,04741
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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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