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104352 L-Histidine

Overview

Replacement Information

Key Spec Table

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

Pricing & Availability

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1043520001
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      Plastic bottle 3 x 500 g
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      1043520500
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          Plastic bottle 0.5 kg
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          1043521000
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              Plastic bottle 1 kg
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              1043529010
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                  Plastic drum 10 kg
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                  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 (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 3 highly 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)≤ 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
                  Catalogue Number GTIN
                  1043520001 04027269365486
                  1043520500 04027269365042
                  1043521000 04022536906829
                  1043529010 04022536906836

                  Documentation

                  Material Qualification Dossier

                  TitleVersion
                  9.0

                  Quality Management Dossier (Open Access)

                  Title

                  Operational Excellence Dossier

                  Title

                  L-Histidine MSDS

                  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

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                  Categories

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                  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