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100129 Kyselina L-asparágová

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
1001291000 Plastová flaša 1 kg
1001299025 Plastový sud 25 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 (rozklad)
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 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +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
1001291000 04022536002194
1001299025 04022536725109

Documentation

Material Qualification Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Kyselina L-asparágová MSDS

Title

Safety Data Sheet (SDS) 

Kyselina L-asparágová Certificates of Analysis

Product Number PackagingSpecificationLot Number
1001291000 Plastová flašaPDF Specification Document
1001299025 Plastový sudPDF Specification Document

Certificates

Title