L(+)-Histidine monohydrochloride monohydrate 98.5-101.0% (dried basis), EMPROVE® EXPERT Ph. Eur., BP, JP, ChP suitable for use as excipient, SAFC®
Catalog # CA1.04354.0500
Supplier: EMD MILLIPORE – PCS CA EXCEP
CAS Number:
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Specifications
- Pack type:Plastic bottle
- Size:500 g
- Cat. no.:CA1.04354.0500
- Supplier No.:1.04354.0500
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
Specification Test Results
About this item
:
:209.63 g/mol
Melting Pt:259 °C (dec.)
Density:1.4723 g/cm³ (20 °C)
EINECS:211-438-9
CAS Number:5934-29-2
Formula:C₆H₉N₃O₂·HCl·H₂O
MDL Number:MFCD00151027