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100129 L-天門冬氨酸

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
56-84-8200-291-6C₄H₇NO₄133.10 g/molPh Eur,BP,ChP,JP,USP

Products

Catalogue NumberPackaging Qty/Pack
1.00129.1000 塑膠瓶 1 kg
Description
Catalogue Number100129
SynonymsL-a-Aminosuccinic acid, L-αlpha-Aminosuccinic acid, Asp
References
Product Information
CAS number56-84-8
EC number200-291-6
GradePh Eur,BP,ChP,JP,USP
Hill FormulaC₄H₇NO₄
Molar Mass133.10 g/mol
HS Code2922 49 85
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.66 g/cm3 (13 °C)
Melting Point230 °C (分解)
pH value3.03 (10 g/l, H₂O)
Bulk density430 kg/m3
Solubility4 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 (alkalimetric, calculated on dried substance)98.5 - 101.0 %
Identity (IR-spectrum)passes test
Identity (enantiomeric purity)passes test
Identity (TLC)passes test
Appearancewhite to almost white, crystalline powder or colorless crystals
Appearance of solution (50 g/l; hydrochloric acid 1 mol/l)clear and not more intense in color than reference solution BY₆
Transmittance of solution (100 g/l, hydrochloric acid 1 mol/l)≥ 98.0 %
Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+24.0 to +26.0
pH (4 g/l CO2-free water)2.5 - 3.5
Acidity (5 g/l, water)2.0 - 4.0
Chloride (Cl)≤ 200 ppm
Sulfate (SO₄)≤ 200 ppm
Heavy metals (as Pb)≤ 10 ppm
Iron (Fe)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Enantiomeric purity (HPLC) (D-aspartic acid)≤ 0.3 %
Dicarboxylic acids (HPLC) (malic acid)≤ 0.2 %
Dicarboxylic acids (HPLC) (fumaric acid)≤ 0.10 %
Dicarboxylic acids (HPLC) (maleic acid)≤ 0.10 %
Dicarboxylic acids (HPLC) (any unspecified impurity)≤ 0.10 %
Dicarboxylic acids (HPLC) (total unspecified impurities)≤ 0.3 %
Related compounds (HPLC) (maleic acid)≤ 0.05 %
Related compounds (HPLC) (malic acid)≤ 0.20 %
Related compounds (HPLC) (fumaric acid)≤ 0.10 %
Related compounds (HPLC) (Any unspecified impurity)≤ 0.05 %
Related compounds (HPLC) (Total unspecified impurities)≤ 0.10 %
Ninhydrin-positive substances (LC)(impurity C (glutamic acid))≤ 0.2 %
Ninhydrin-positive substances (LC)(impurity D (alanine))≤ 0.2 %
Ninhydrin-positive substances (LC)(impurity G (asparagine))≤ 0.2 %
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)≤ 0.10 %
Ninhydrin-positive substances (LC) (total impurities)≤ 1.0 %
Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %
Other amino acids (TLC)≤ 0.5 %
Related substances (TLC)passes test
Residual solvents (ICH Q3C)excluded by manufacturing process
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (105 °C; 3 h)≤ 0.20 %
Bacterial endotoxins≤ 25 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 (*).
Compliance with pyrogens (according to ChP) is guaranteed by the test for bacterial endotoxins (ChP) and the production process.
Corresponds to Ph. Eur., BP, ChP, JP, USP.
Global Trade Item Number
Catalogue Number GTIN
1.00129.1000 04022536002194

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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L-天門冬氨酸 MSDS

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Safety Data Sheet (SDS) 

L-天門冬氨酸 Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.00129.1000 塑膠瓶PDF Specification Document

Certificates

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