L(+)-Asparagine monohydrate 99.0-101.0% (dry basis), EMPROVE® exp Ph. Eur. suitable for use as excipient, SAFC®
Supplier: MilliporeSigma
Synonyms:
H-Asn-OH.H2O
, H-Asn-OH·H₂O
, L-Asparagine monohydrate
, (S)-(+)-Asparagine monohydrate
, (S)-2,4-Diamino-4-oxobutanoic acid hydrate
1.01565.5000
EM1.01565.5000EA
5021
USD
EM1.01565.5000
L(+)-Asparagine monohydrate 99.0-101.0% (dry basis), EMPROVE® exp Ph. Eur. suitable for use as excipient, SAFC®
L(+)-Asparagine monohydrate
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.
|
Formula:
C₄H₈N₂O₃·1H₂O MW: 150.13 g/mol Melting Pt: 215…217 °C Density: 1.567 g/cm³ (20 °C) Storage Temperature: Ambient |
MDL Number:
MFCD00151038 CAS Number: 5794-13-8 EINECS: 200-735-9 Merck Index: 13,00842 |
Specification Test Results
| Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance | white to almost white crystalline powder or colorless crystals |
| Appearance of solution (20 g/l, CO₂-free water) | clear and colorless |
| Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance) | +33.7 to +36.0 |
| pH (20 g/l, CO₂-free water) | 4.0 - 6.0 |
| Chloride (Cl) | ≤ 200 ppm |
| Sulphate (SO₄) | ≤ 200 ppm |
| Fe (Iron) | ≤ 10 ppm |
| NH₄ (Ammonium) | ≤ 0.1 % |
| Aspartic acid | ≤ 0.5 % |
| Ninhydrin - positive substances (TLC) (Glutamic acid) | ≤ 0.5 % |
| Ninhydrin - positive substances (TLC) (any other impurity) | ≤ 0.5 % |
| Ethanol (HS-GC) | ≤ 5000 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Loss on drying (130 °C, 3 h) | 10.5 - 12.5 % |
| Bacterial endotoxins | ≤ 3.0 I.U./g |
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