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101565 L-Asparagine monohydrate

EMPROVE® EXPERT Ph Eur,ChP,NF

L-Asparagine monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Asparaginic acid semiamide, Asn

CAS #: 5794-13-8 EC Number: 200-735-9 Molar Mass: 150.14 g/mol Hill Formula: C₄H₈N₂O₃ * H₂O Grade: Ph Eur,ChP,NF
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
5794-13-8200-735-9C₄H₈N₂O₃ * H₂O150.14 g/molPh Eur,ChP,NF

Products

Catalogue NumberPackaging Qty/Pack
1.01565.1000 Plastic bottle 1 kg
1.01565.5000 Plastic drum 5 kg
Description
Catalogue Number101565
SynonymsAsparaginic acid semiamide, Asn
References
Product Information
CAS number5794-13-8
EC number200-735-9
GradePh Eur,ChP,NF
Hill FormulaC₄H₈N₂O₃ * H₂O
Molar Mass150.14 g/mol
HS Code2924 19 00
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Melting Point215 - 217 °C decomposes
pH value4.0 - 5.5 (20 g/l, H₂O, 20 °C)
Bulk density530 kg/m3
Solubility22 g/l
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %
Assay (HPLC, calculated on dried substance)95.5 - 102.0 %
Identity (IR-spectrum)passes test
Identity (specific rotation)passes test
Identity (HPLC)passes test
Identity (loss on drying)passes test
Identity (wet chemistry)passes test
Identity (TLC)passes test
Appearancewhite to almost white crystalline powder or colorless crystals
Appearance of solution (20 g/l, CO₂-free water)clear and not more intense in color than reference solution B₉
Transmittance of solution (20 g/l, water)≥ 98.0 %
pH (20 g/l, CO₂-free water)4.0 - 6.0
Spec. rotation (α 20/D, 100 g/l, hydrochloric acid 3 mol/l, calc. on dried substance)+33.7 to +36.0
Spec. rotation (α 20/D, 20 g/l, hydrochloric acid 3 mol/l,calc. on dried substance)+31.0 to +35.0
Spec. rotation (α 20/D, 10 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+33.0 to +36.5
Chloride (Cl)≤ 50 ppm
Sulfate (SO₄)≤ 50 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Fe (Iron)≤ 10 ppm
Pb (Lead)≤ 5 ppm
NH₄ (Ammonium)≤ 0.1 %
Other amino acids (TLC)≤ 0.5 %
Related substances (HPLC) (impurity A)≤ 0.5 %
Related substances (HPLC) (impurity C)≤ 0.1 %
Related substances (HPLC) (any unspecified impurity)≤ 0.05 %
Related substances (HPLC) (total impurities)≤ 0.8 %
Organic Impurities (HPLC) (Asparagine related compound A (2,2’-(3,6-Dioxopiperazine-2,5-diyl)diacetamide))≤ 1.0 %
Organic Impurities (HPLC) (Aspartic acid)≤ 1.0 %
Organic Impurities (HPLC) (any unspecified impurity)≤ 0.5 %
Organic Impurities (HPLC) (total impurities)≤ 3.0 %
Ethanol (HS-GC)≤ 5000 ppm
Other residual solvents (ICH Q3C)excluded by manufacturing process
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (105 °C; 3 h)11.5 - 12.5 %
Loss on drying (130 °C, 3 h)11.5 - 12.5 %
Bacterial endotoxins≤ 3.0 I.U./g
Microbiological test (total aerobic microbial count (TAMC))≤ 10²
Microbiological test (total yeast and mould count (TYMC))≤ 10²
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., ChP, NF
Global Trade Item Number
Catalogue Number GTIN
1.01565.1000 04022536022819
1.01565.5000 04022536732602

Documentation

Material Qualification Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Asparagine monohydrate SDS

Title

Safety Data Sheet (SDS) 

L-Asparagine monohydrate Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.01565.1000 Plastic bottlePDF Specification Document
1.01565.5000 Plastic drumPDF Specification Document

Certificates

Title

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Categories

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Semisolid Dosage Form > Ingredients - Semi Solid
Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Amino Acids