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101565 L-Asparagin monohydrát

EMPROVE® EXPERT Ph Eur,ChP,NF

L-Asparagin monohydrát 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
101565
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Tabulka spec. kláve

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

Products

Katalogové čísloBalení ks/bal.
1015651000 Plastová láhev 1 kg
1015655000 Plastový sud 5 kg
1015659010 Plastový sud 10 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 rozkládá se
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 Ostatní kapalné a tuhé látky
WGKWGK 1 látka mírně ohrožující vody
Disposal3
Relativně nereaktivní organické reagencie mohou být shromažďovány v kontejneru A. Pokud jsou halogenované, musí být umístěny v kontejneru B. U pevných reziduí použijte kontejner C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladovat od +2°C až +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
Katalogové číslo GTIN
1015651000 04022536022819
1015655000 04022536732602
1015659010 04022536732619

Documentation

Material Qualification Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Asparagin monohydrát MSDS

Title

Safety Data Sheet (SDS) 

L-Asparagin monohydrát Certificates of Analysis

Katalogové číslo BaleníSpecifikaceČíslo šarže
1015651000 Plastová láhevSpecifikující dokument ve formátu PDF
1015655000 Plastový sudSpecifikující dokument ve formátu PDF
1015659010 Plastový sudSpecifikující dokument ve formátu PDF

Certificates

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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