L-Asparagine monohydrate

SKU:
TC057M
CAS Number : 5794-13-8
Molecular Formula : C₄H₈N₂O₃.H₂O
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Product Identifier

Product Code TC057M

Technical Specification

Molecular weight 150.13
Molecular formula C4H8N2O3.H2O
CAS No. 5794-13-8
Appearance (USP) White crystals or a crystalline powder
Appearance (EP, BP) White or almost white crystalline powder or colourless crystals
Solubility (USP) Soluble in water, practically insoluble in alcohol and in ether
Solubility (EP, BP) Slightly soluble in water, practically insoluble in ethanol (96%) and in methylene chloride
pH (c = 2% in water at 25°C) (EP, BP) 4.00 - 6.00
Identification A, FTIR (USP) Matches with the standard pattern
Identification A, Specific rotation (EP, BP) +33.7° to +36.0° (c = 10% in 3N HCl, dried substance)
Identification B, FTIR (EP, BP) Matches with the standard pattern
Identification C, TLC (EP, BP) The principle spot in the chromatogram obtained with test solution (b) is similar in position, colour and size to the principle spot in the chromatogram obtained with reference solution
Identification D, Loss on drying (at 130°C, 3hr) (EP, BP) 10.50 - 12.50%
Appearance of solution (EP, BP) 2% solution is clear and colourless.
Lead (USP) <= 0.0005%
Chloride (EP, BP) <= 0.02%
Sulphate (EP, BP) <= 0.02%
Iron (EP, BP) <= 0.001%
Ammonium (EP, BP) <= 0.1%
Chromatographic purity, TLC (USP) No secondary spot from the sample solution is larger or more intense than the principal spot from the standard solution (0.5%), and <= 1.0% of total impurities is found
Microbial enumeration test, TAMC (USP) <= 1000 cfu/g
Microbial enumeration test, TYMC (USP) <= 100 cfu/g
Related substances, system suitability, Resolution, HPLC: (EP, BP) >= 5.0, between the peaks due to asparagine and impurity A
Related substances 1 (HPLC): Impurities A (EP, BP) <= 0.50%
Related substances 2 (HPLC): Impurity C (EP, BP) <= 0.1%
Related substances 3 (HPLC): Unspecified impurities for each impurity (EP, BP) <= 0.05%
Related substances : Total impurities, HPLC (EP, BP) <= 0.8%
Sulphated ash (EP, BP) <= 0.1%
Residue on ignition (USP) <= 0.1%
Specific rotation (EP, BP) +33.7° to +36.0° (c = 10% in 3N HCl, dried substance)
Specific rotation (USP) +33.0° to +36.5° (c = 1% in 6N HCl, at 20°C)
Loss on drying (at 130°C, 3hr) (EP, BP) 10.50 - 12.50%
Loss on drying (at 130°C, 3hr) (USP) 11.50 - 12.50%
Assay (NT, on dry basis) (USP) 98.00 - 101.50%
Assay (NT, on dry basis) (EP, BP) 99.00 - 101.00%

Storage and Shelf Life

Storage condition Store below 30°C away from bright light.
Shelf life 48 months.
Usage instruction Use before expiry date given on the product label.
CAS Number : 5794-13-8
Molecular Formula : C₄H₈N₂O₃.H₂O
More Information
Product Name L-Asparagine monohydrate
SKU TC057M
CAS No 5794-13-8
EC No. 200-735-9
Molecular formula C₄H₈N₂O₃.H₂O
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