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101565 L-Asparagina, monohydrat

EMPROVE® EXPERT Ph Eur,ChP,NF

L-Asparagina, monohydrat 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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Tabela kluczowych gatunków

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

Products

Numer katalogowyOpakowanie Ilość/opak.
1015651000 Butelka plastikowa 1 kg
1015655000 Beben plastikowy 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 rozkłada się
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 Inne substancje ciekłe i stałe
WGKWGK 1 lekkie zanieczyszczenie wody
Disposal3
Względnie niereaktywne odczynniki organiczne należy zbierać w Kategorii A. Odczynniki chlorowcowane należy umieszczać w Kategorii B. Do pozostałości stałych stosować Kategorię C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +2°C do +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
Numer katalogowy GTIN
1015651000 04022536022819
1015655000 04022536732602

Documentation

Emprove Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Asparagina, monohydrat MSDS

Title

Safety Data Sheet (SDS) 

L-Asparagina, monohydrat Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1015651000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1015655000 Beben plastikowyDokument ze specyfikacją, w formacie PDF

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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