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104352 L-Histidine

EMPROVE® EXPERT Ph Eur,ChP,JP,USP

L-Histidine 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
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104352
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Key Spec Table

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

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1043521000
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      1043529010
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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
          1043521000 04022536906829
          1043529010 04022536906836

          Documentation

          Material Qualification Dossier

          TitleVersion
          9.0

          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
          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