L(+)-Histidine 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT USP, JP, Ph. Eur. suitable for use as excipient, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

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Supplier: MERCK PRODUCTION CHEMICALS

Certificates

About this item

Synonyms: L-3-Imidazol-4-ylalanine, (S)-(+)-Histidine, (S)-2-Amino-3-(4-imidazolyl)propionic acid, H-His-OH, NSC 137773, L-Histidine

CAS Number:71-00-1

Formula:C₆H₉N₃O₂

MDL Number:MFCD00064315

Density:1.44 g/cm³ (20 °C)

Molecular Weight:155.16 g/mol

Melting Pt:272…273 °C

Merck Index:13,04741

Storage Temperature:Ambient

EINECS:200-745-3

Specifications

Environmentally Preferable:

Specifications

Specification Test Results

Assay (acidimetric, calculated on dried substance):
98.5 - 101.0 %
Assay (perchloric acid titration, calculated on dried substance):
99.0 - 101.0 %
Identity (IR-spectrum):
passes test
Appearance:
white to almost white fine-crystalline powder or colorless crystals
Appearance of solution (50 g/l; water):
clear and not more intense in color than reference solution BY₇.
Appearance of solution (20 g/l, water):
clear and colorless
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance):
+11.4 to +12.4
Spec. rotation (α 25/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance):
+12.6 to +14.0
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance):
+11,8° to +12,8°
pH (20 g/l, CO₂-free water):
7.0 - 8.5
Chloride (Cl):
≤ 200 ppm
Sulfate (SO₄):
≤ 200 ppm
Heavy metals (as Pb):
≤ 10 ppm
Cu(Copper):
≤ 25 ppm
Fe (Iron):
≤ 10 ppm
Fe (Iron) (ICP):
≤ 10 ppm
Mn (Manganese):
≤ 25 ppm
Zn (Zinc):
≤ 130 ppm
Related Compounds, total (TLC):
≤ 0.5 %
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 (105 °C; 3 h):
≤ 0.2 %
Bacterial endotoxins:
< 2.0
Microbiological test (total aerobic microbial count (TAMC)):
≤ 10²
Microbiological test (total yeast and mould count (TYMC)):
≤ 10²