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

Supplier: EMD MILLIPORE - PCS - GPS
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Total Ratings: 0
Avg. Ratings: 0.0 out of 5

1.04352.1000 1.04352.9010
EM1.04352.1000CS 25419.73 USD
EM1.04352.1000 EM1.04352.9010
L(+)-Histidine 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., USP, JP, SAFC®
L(+)-Histidine
Formula: C₆H₉N₃O₂
Melting Pt: 272...273 °C Dec.
Density: 0.43 g/cm³
Storage Temperature: Ambient
MDL Number: MFCD00064315
CAS Number: 71-00-1
EINECS: 200-745-3
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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
Specific Rotation (α 20/D, 110 g/l, Hydrochloric Acid 120 g/l, Calculated on Dried Substance) +11.4 to +12.4
Specific Rotation (α 25/D, 110 g/l, Hydrochloric Acid 6 mol/l, Calculated on Dried Substance) +12.6 to +14.0
Specific Rotation (α 20/D, 110 g/l, Hydrochloric Acid 6 mol/l, Calculated 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
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., JP, USP

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