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

Dostawca: MERCK PRODUCTION CHEMICALS

1.04352.1000EA 0 PLN
1.04352.1000 1.04352.9010
L(+)-histydyna 99.0-101.0% (by perchloric acid titration), EMPROVE® EXPERT Ph. Eur., USP, JP, SAFC®
L(+)-histydyna
Formuła: C₆H₉N₃O₂
MW: 155,16 g/mol
Temp. topnienia: 272…273 °C
Gęstość: 1,44 g/cm³ (20 °C)
Temperatura przechowywania: Temperatura otoczenia
Numer MDL: MFCD00064315
Numer CAS: 71-00-1
Numer WE (dawny EINECS): 200-745-3
Klasyfikacja Merck : 13,04741
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Wyniki testów specyfikacyjnych

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
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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