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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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1043520500
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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
              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 SDS

              Title

              Safety Data Sheet (SDS) 

              L-Histidine Certificates of Analysis

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

              Certificates

              Title

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              Small Molecule Pharmaceuticals > Formulation > Liquid Dosage Form > Ingredients - Liquid
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              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