104352 L-Histidine

104352
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      71-00-1 200-745-3 C₆H₉N₃O₂ 155.16 g/mol Ph Eur,USP,JP

      Pricing & Availability

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      1043520001
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          Plastic bottle 3 x 500 g
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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,USP,JP
                  Hill FormulaC₆H₉N₃O₂
                  Molar Mass155.16 g/mol
                  HS Code2933 29 90
                  Structure formula ImageStructure formula Image
                  Applications
                  Biological Information
                  Physicochemical Information
                  Melting Point272 - 273 °C (decomposition)
                  pH value7.7 (10 g/l, H₂O, 20 °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 +5°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
                  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
                  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)+11,8° to +12,8°
                  pH (20 g/l, CO₂-free water)7.0 - 8.5
                  Chloride (Cl)≤ 200 ppm
                  Sulfate (SO₄)≤ 200 ppm
                  Heavy metals (as Pb)≤ 10 ppm
                  Cu (Copper)*≤ 25 ppm
                  Fe (Iron)≤ 10 ppm
                  Fe (Iron) (ICP)≤ 10 ppm
                  Mn (Manganese)≤ 25 ppm
                  Zn (Zinc)≤ 130 ppm
                  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
                  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., JP, USP

                  Documentation

                  Material Qualification Dossier

                  Title

                  Quality Management Dossier

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