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104352 L-Histidine

Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
71-00-1200-745-3C₆H₉N₃O₂155.16 g/molPh Eur,ChP,JP,USP

Products

Catalogue NumberPackaging Qty/Pack
1043520001 Plastic bottle 3 x 500 g
1043520500 Plastic bottle 0.5 kg
1043521000 Plastic bottle 1 kg
1043529010 Plastic drum 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 Mass155.16 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 (decomposition)
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 Rat > 5110 mg/kg
Safety Information according to GHS
RTECSMS3070000
Storage class10 - 13 Other liquids and solids
WGKWGK 1 slightly hazardous to water
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +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)≤ 5 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
Catalogue Number GTIN
1043520001 04027269365486
1043520500 04027269365042
1043521000 04022536906829
1043529010 04022536906836

Documentation

Material Qualification Dossier

TitleVersion
7.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

L-Histidine SDS

Title

Safety Data Sheet (SDS) 

L-Histidine Certificates of Analysis

Product Number PackagingSpecificationLot Number
1043520001 Plastic bottlePDF Specification Document
1043520500 Plastic bottlePDF Specification Document
1043521000 Plastic bottlePDF Specification Document
1043529010 Plastic drumPDF Specification Document

Certificates

Title

Related Products & Applications

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Categories

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