L(+)-Asparagine monohydrate 98.0-101.5% NF, Multi-Compendial, J.T.Baker®
Supplier: Avantor
Synonyms:
H-Asn-OH.H2O
, H-Asn-OH·H₂O
, L-Asparagine monohydrate
, (S)-(+)-Asparagine monohydrate
, (S)-2,4-Diamino-4-oxobutanoic acid hydrate
Management of Change (MOC) category = R
2068-06EA
110000
INR
2068-06
2068-K1
2068-SA
2068-B1
L(+)-Asparagine monohydrate 98.0-101.5% NF, Multi-Compendial, J.T.Baker®
L(+)-Asparagine monohydrate
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
Meets E.P. Chemical Specifications | |
Meets B.P. Chemical Specifications | |
GMP Manufactured Product | |
Meets N.F. Requirements | |
Store in well-closed,light-resistant containers | |
Preserve in well-closed containers. | |
CAUTION: For Manufacturing, processing or repackaging | |
Bulk Pharmaceutical Chemical | For Information Only |
NF - Assay (dried basis) | 98.0 - 101.5 % |
NF - Identification A | Passes Test |
NF - Identification B | Passes Test |
NF - Specific Rotation @ 20 °C (+) | 33.0 - 36.5 Degree |
NF - Loss on Drying at 130°C | 11.5 - 12.5 % |
NF - Residue on Ignition | ≤ 0.1 % |
NF - Chromatographic Purity: Asparagine related compound A | ≤ 1.0 % |
NF - Chromatographic Purity: Aspartic acid | ≤ 1.0 % |
NF - Chromatographic Purity: Each individual unidentified impurity | ≤ 0.5 % |
NF - Chromatographic Purity: Total impurities | ≤ 3.0 % |
NF - Lead (Pb) | ≤ 5 ppm |
NF - Total Aerobic Microbial Count, cfu/g | ≤ 1000 |
NF - Total Yeast and Mold Count, cfu/g | ≤ 100 |
EP/BP - Assay (dried basis) | 99.0 - 101.0 % |
EP/BP - Identification A | Passes Test |
EP/BP - Identification B | Passes Test |
EP/BP - Identification D | Passes Test |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Specific Rotation @ 20 °C (+) | 33.7 - 36.0 Degree |
EP/BP - Chloride (Cl) | ≤ 200 ppm |
EP/BP - Sulfate (SO₄) | ≤ 200 ppm |
EP/BP - Ammonium (NH₄) | ≤ 0.1 % |
EP/BP - Iron (Fe) | ≤ 10 ppm |
EP/BP - Loss on Drying at 130° C | 10.5 - 12.5 % |
EP/BP - Sulfated Ash | ≤ 0.1 % |
EP/BP - pH | 4.0 - 6.0 |
EP/BP - Related Substances - Impurity A | ≤ 0.5 % |
EP/BP - Related Substances - Impurity C | ≤ 0.1 % |
EP/BP - Related Substances - Unspecified impurities, each | ≤ 0.05 % |
EP/BP - Related Substances - Total impurities | ≤ 0.8 % |
Endotoxin Concentration, IU/mg, For Information Only | |
Residual solvents: Only the Class 2 solvent methanol is likely to be | |
present from use in the manufacturing process. Methanol content is | |
controlled to <200 ppm as a manufacturing process limit. | |
Elemental Impurities (USP 232, EP 5.20) - Information on elemental | |
impurities for this product is available on the associated Product | |
Regulatory Data Sheet and elemental impurity profile report. |
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