104352 L-Histidine

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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              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
              Quality LevelMQ500
              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