L(+)-Arginine 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
Supplier: MilliporeSigma
1.01587.1000
1.01587.9010
EM1.01587.1000CS
5231.37
USD
EM1.01587.1000
EM1.01587.9010
L(+)-Arginine 98.5-101.0%, EMPROVE® EXPERT Ph. Eur., JP, USP suitable for use as excipient, SAFC®
L(+)-Arginine
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 (*).
Certificaciones: Corresponds to Ph. Eur., JP, USP.
|
Formula:
C₆H₁₄N₄O₂ Boiling Pt: 368 °C (1013 hPa) Melting Pt: 238 °C (dec.) Density: 1.3 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00002635 CAS Number: 74-79-3 EINECS: 200-811-1 |
Specification Test Results
| Assay (perchloric acid titration, calculated on dried substance) | 98.5 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white, crystalline powder or colorless crystals |
| Appearance of solution (50 g/l; water) | clear and not more intense in color than reference solution BY₆ |
| Appearance of solution (100 g/l, CO₂-free water) | clear and colorless |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance) | +25.5 to +28.5 |
| Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance) | +26.3 to +27.7 |
| Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance) | +26.9 to +27.9 |
| pH (100 g/l, CO₂-free water) | 10.5 - 12.0 |
| 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 |
| Mo (Molybdenum)* | ≤ 2.5 ppm |
| Ni (Nickel)* | ≤ 2 ppm |
| Zn (Zinc) | ≤ 130 ppm |
| Related Compounds, total (TLC) | ≤ 0.5 % |
| 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) | ≤ 0.30 % |
| Bacterial endotoxins | ≤ 2.0 I.U./g |
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