L(+)-Asparagine monohydrate 98.0-101.5% NF, Multi-Compendial, J.T.Baker®

Supplier: Avantor

Synonyms: H-Asn-OH.H2OL-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

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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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