L(+)-Asparagine monohydrate 99.0-101.0% (dry basis), EMPROVE® EXPERT Ph. Eur. suitable for use as excipient, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS

Synonyms: L-Asparagine monohydrate, H-Asn-OH·H₂O, (S)-(+)-Asparagine monohydrate, (S)-2,4-Diamino-4-oxobutanoic acid hydrate, H-Asn-OH.H2O

1.01565.1000 1.01565.5000 1.01565.9010
1.01565.1000EA 1830 GBP
1.01565.1000 1.01565.5000 1.01565.9010
L(+)-Asparagine monohydrate 99.0-101.0% (dry basis), EMPROVE® EXPERT 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: 14,00837

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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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