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

Supplier: MERCK PRODUCTION CHEMICALS

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About this item

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

CAS Number:5934-29-2

Formula:C₆H₉N₃O₂·HCl·H₂O

MDL Number:MFCD00151027

:209.63 g/mol

Merck Index:13,04741

Melting Pt:259 °C (dec.)

Density:1.4723 g/cm³ (20 °C)

Storage Temperature:Ambient

EINECS:211-438-9

Specifications

Environmentally Preferable:

Specifications

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