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104354 L-Histydyny monochlorowodorek, monohydrat

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Tabela kluczowych gatunków

CAS #EC NumberHill FormulaMolar MassGrade Value
5934-29-2211-438-9C₆H₁₀ClN₃O₂ * H₂O209.63 g/molPh Eur,BP,ChP,JP

Products

Numer katalogowyOpakowanie Ilość/opak.
1043540500 Butelka plastikowa 500 g
1043549010 Beben plastikowy 10 kg
Description
Catalogue Number104354
SynonymsHis
References
Product Information
CAS number5934-29-2
EC number211-438-9
GradePh Eur,BP,ChP,JP
Hill FormulaC₆H₁₀ClN₃O₂ * H₂O
Molar Mass209.63 g/mol
HS Code2933 29 92
Structure formula ImageStructure formula Image
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Density1.4723 g/cm3 (20 °C)
Melting Point256 - 268 °C (rozkład)
pH value4.38 - 4.48 (149.55 g/l, H₂O, 20 °C)
Vapor pressure<0.1 hPa (20 °C)
Bulk density770 kg/m3
Solubility149.55 g/l
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
RTECSMS3119000
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 (calculated on dried substance)99.0 - 101.0 %
Assay (calc.on anhydrous substance)99.0 - 101.0 %
Identity (IR-spectrum)passes test
Identity (pH)passes test
Identity (wet chemistry)passes test
Identity (specific rotation)passes test
Identity (TLC)passes test
Appearancewhite to almost white crystalline powder or colorless crystals
Appearance of solution (50 g/l CO₂-free water)clear and not more intense in color than reference solution BY₆
Appearance of solution (100 g/l, CO₂-free water)clear and colorless
Transmittance of solution (100 g/l, water)≥ 98.0 %
pH (50 g/l CO₂-free water)3.0 - 5.0
pH (100 g/l, CO₂-free water)3.5 - 4.5
Acidity (100 g/l, water)3.5 - 4.5
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 120 g/l, calc. on dried substance)+9.2 to +10.6
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+8.5 to +10.5
Spec. rotation (α 20/D, 110 g/l, hydrochloric acid 6 mol/l, calc. on anhydrous substance)+9.2 to +10.6
Chloride (argentometric, calc. on dried substance)16.7 - 17.1 %
Sulfate (SO₄)≤ 200 ppm
Heavy metals (as Pb)≤ 10 ppm
As (Arsenic)≤ 1 ppm
Fe (Iron)≤ 10 ppm
Other amino acids (TLC)≤ 0.2 %
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 (150 °C)7.0 - 10.0 %
Loss on drying (105 °C; 3 h)≤ 0.2 %
Water (according to Karl Fischer)7.2 - 10.0 %
Bacterial endotoxins≤ 20 I.U./g
Bacterial endotoxins (ChP)< 6.0
Microbiological test (total aerobic microbial count (TAMC))≤ 10²
Microbiological test (total yeast and mould count (TYMC))≤ 10¹
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., BP, ChP, JP
Global Trade Item Number
Numer katalogowy GTIN
1043540500 04022536050348
1043549010 04022536732657

Documentation

Emprove Dossier

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9.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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L-Histydyny monochlorowodorek, monohydrat MSDS

Title

Safety Data Sheet (SDS) 

L-Histydyny monochlorowodorek, monohydrat Certificates of Analysis

Numer katalogowy OpakowanieSpecyfikacjaNumer partii
1043540500 Butelka plastikowaDokument ze specyfikacją, w formacie PDF
1043549010 Beben plastikowyDokument ze specyfikacją, w formacie PDF

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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