L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP suitable for use as excipient, SAFC®
1.04354.9010
:
- Pk:10 kg
- Seq:4158
- 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
:
:209.63 g/mol
:13,04741
:259 °C (dec.)
:1.4723 g/cm³ (20 °C)
:Ambient
:211-438-9
:5934-29-2
:C₆H₉N₃O₂·HCl·H₂O
:MFCD00151027