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104352 L-Histydyna

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

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

Synonyms: His

CAS #: 71-00-1 EC Number: 200-745-3 Molar Mass: 155.15 g/mol Hill Formula: C₆H₉N₃O₂ Grade: Ph Eur,ChP,JP,USP
104352
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Tabela kluczowych gatunków

CAS #EC NumberHill FormulaMolar MassGrade Value
71-00-1200-745-3C₆H₉N₃O₂155.15 g/molPh Eur,ChP,JP,USP

Products

Numer katalogowyOpakowanie Ilość/opak.
1043520500 Butelka plastikowa 0.5 kg
1043521000 Butelka plastikowa 1 kg
1043529010 Beben plastikowy 10 kg
Description
Catalogue Number104352
SynonymsHis
References
Product Information
CAS number71-00-1
EC number200-745-3
GradePh Eur,ChP,JP,USP
Hill FormulaC₆H₉N₃O₂
Molar Mass155.15 g/mol
HS Code2933 29 92
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.449 g/cm3 (20 °C)
Melting Point285 °C (rozkład)
pH value7.0 - 8 (15.5 g/l, H₂O, 25 °C)
Bulk density430 kg/m3
Solubility38.2 g/l
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Szczur > 5110 mg/kg
Safety Information according to GHS
RTECSMS3070000
Storage class10 - 13 Inne substancje ciekłe i stałe
WGKWGK 3 silne zanieczyszczenie wody
Safety Information
Product Usage Statements
Storage and Shipping Information
StoragePrzechowywać w +2°C do +30°C.
Packaging Information
Transport Information
Supplemental Information
Specifications
Assay (acidimetric, calculated on dried substance)98.5 - 101.0 %
Assay (perchloric acid titration, calculated on dried substance)99.0 - 101.0 %
Identity (IR-spectrum)passes test
Identity (specific rotation)passes test
Identity (TLC)passes test
Appearancewhite to almost white fine-crystalline powder or colorless crystals
Appearance of solution (50 g/l; water)clear and not more intense in color than reference solution BY₇.
Appearance of solution (20 g/l, water)clear and colorless
Transmittance of solution (30 g/l, water)≥ 98.0 %
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance)+11.4 to +12.4
Spec. rotation (α 25/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+12.6 to +14.0
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+12.0 to +12.8
pH (20 g/l, CO₂-free water)7.0 - 8.5
Acidity (20g/l, water)7.0 - 8.5
Chloride (Cl)≤ 200 ppm
Sulfate (SO₄)≤ 200 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Cu(Copper)≤ 25 ppm
Fe (Iron)≤ 10 ppm
Mn (Manganese)≤ 25 ppm
Zn (Zinc)≤ 130 ppm
Other amino acids (TLC)≤ 0.5 %
Related Compounds, total (TLC)≤ 0.5 %
Related substances (TLC)passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity)≤ 0.2 %
Ninhydrin-positive substances (LC) (ammonium (570 nm))≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities)≤ 0.5 %
Residual solvents (ICH (Q3C))excluded by manufacturing process
Sulfated ash (600 °C)≤ 0.1 %
Loss on drying (105 °C; 3 h)≤ 0.2 %
Bacterial endotoxins< 2.0
Bacterial endotoxins (ChP)< 6.0
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, JP, USP
Global Trade Item Number
Numer katalogowy GTIN
1043520500 04027269365042
1043521000 04022536906829
1043529010 04022536906836

Documentation

Emprove Dossier

TitleVersion
9.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Histydyna MSDS

Title

Safety Data Sheet (SDS) 

L-Histydyna Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1043520500 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1043521000 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1043529010 Beben plastikowyDokument ze specyfikacją, w formacie PDF

Certificates

Title

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Kategorie

Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Ingredients - Liquid
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
Biopharmaceutical Manufacturing > Upstream Processing > Cell Culture > Cell Culture Ingredients and Supplements > Cell Culture Ingredients > Amino Acids
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > pH Adjustments and Isotonizers
Biopharmaceutical Manufacturing > Formulation > Liquid Dosage > Surfactants and Stabilizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > pH Adjustments and Isotonizers
Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Surfactants and Stabilizers