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101544 L-Arginine monohydrochloride

EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

L-Arginine monohydrochloride MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: a-Amino-d-guanidino valerianic acid hydrochloride, alpha-Amino-delta-guanidino valerianic acid hydrochloride, Arg, α-Amino-δ-guanidino valerianic acid hydrochloride

CAS #: 1119-34-2 EC Number: 214-275-1 Molar Mass: 210.67 g/mol Chemical Formula: C₆H₁₄N₄O₂*HCl Hill Formula: C₆H₁₄N₄O₂˙ ClH Grade: Ph Eur,BP,ChP,JP,USP
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101544
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaChemical FormulaMolar MassGrade Value
1119-34-2214-275-1C₆H₁₄N₄O₂˙ ClHC₆H₁₄N₄O₂*HCl210.67 g/molPh Eur,BP,ChP,JP,USP

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          1.01544.9010
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              Description
              Catalogue Number101544
              Synonymsa-Amino-d-guanidino valerianic acid hydrochloride, alpha-Amino-delta-guanidino valerianic acid hydrochloride, Arg, α-Amino-δ-guanidino valerianic acid hydrochloride
              DescriptionL-Arginine monohydrochloride
              References
              Product Information
              CAS number1119-34-2
              EC number214-275-1
              GradePh Eur,BP,ChP,JP,USP
              Hill FormulaC₆H₁₄N₄O₂˙ ClH
              Chemical formulaC₆H₁₄N₄O₂*HCl
              Molar Mass210.67 g/mol
              HS Code2925 29 19
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Density1.42 g/cm3 (20 °C)
              Melting Point>235 °C
              pH value5.5 - 7 (211 g/l, H₂O, 25 °C)
              Vapor pressure<0.1 Pa (20 °C)
              Bulk density1250 kg/m3
              Solubility730 g/l
              Dimensions
              Materials Information
              Toxicological Information
              LD 50 oralLD50 Rat 12000 mg/kg
              Safety Information according to GHS
              RTECSCF1995500
              Storage class10 - 13 Other liquids and solids
              WGKWGK 1 slightly hazardous to water
              Disposal3
              Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
              Safety Information
              Product Usage Statements
              Storage and Shipping Information
              StorageStore at +2°C to +30°C.
              Packaging Information
              Transport Information
              Supplemental Information
              Specifications
              Assay (perchloric acid titration, calculated on dried substance)98.5 - 101.0 %
              Identity (IR-spectrum)passes test
              Identity (wet chemistry)passes test
              Identity (specific rotation)passes test
              Identity (TLC)passes test
              Appearancewhite to almost white or colorless, irregular crystals
              Appearance of solution (50 g/l; water)clear and not more intense in color than reference solution BY₆
              Appearance of solution (100 g/l, water)clear and colorless
              Transmittance of solution (100 g/l, water)≥ 98.0 %
              pH (100 g/l, CO₂-free water)4.7 - 6.2
              Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+21.0 to +23.5
              Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+21.5 to +23.5
              Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l,previously dried substance)+21.5 to +23.5
              Chloride (Cl) (argentometric)16.5 - 17.1 %
              Chloride (argentometric, calc. on dried substance)16.5 - 17.1 %
              Proteinspasses test
              Sulfate (SO₄)≤ 200 ppm
              Phosphate (PO43-)≤ 200 ppm
              Heavy metals (as Pb)≤ 10 ppm
              As (Arsenic)≤ 1 ppm
              Fe (Iron)≤ 10 ppm
              Other amino acids (TLC)≤ 0.2 %
              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, 2 h)≤ 0.20 %
              Bacterial endotoxins≤ 3.0 I.U./g
              Bacterial endotoxins (ChP)≤ 3.0 I.U./g
              Microbiological test (total aerobic microbial count (TAMC))≤ 10²
              Microbiological test (total yeast and mould count (TYMC))≤ 10¹
              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 (*).
              Compliance with pyrogens (according to ChP) is guaranteed by the test for bacterial endotoxins (ChP) and the production process.
              Corresponds to Ph. Eur., BP, ChP, JP, USP.
              Global Trade Item Number
              Catalogue Number GTIN
              1.01544.1000 04022536022512
              1.01544.5000 04022536732596
              1.01544.9010 04022536706757

              Documentation

              Material Qualification Dossier

              TitleVersion
              10.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              L-Arginine monohydrochloride SDS

              Title

              Safety Data Sheet (SDS) 

              L-Arginine monohydrochloride Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.01544.1000 Plastic bottlePDF Specification Document
              1.01544.5000 Plastic drumPDF Specification Document
              1.01544.9010 Plastic drumPDF Specification Document

              Certificates

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              Brochure

              Title
              バイオ医薬品製造用製品ガイド