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101544 Monoclorhidrat de L-arginina

adecvat pentru utilizare ca excipient EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

Monoclorhidrat de L-arginina 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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      1015441000
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          1015445000
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              1015449010
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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 Alte lichide sau solide
                  WGKWGK 1 slabă contaminare a apei
                  Disposal3
                  Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
                  Safety Information
                  Product Usage Statements
                  Storage and Shipping Information
                  StorageA se depozita între +2°C la +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
                  1015440001 04027269365158
                  1015441000 04022536022512
                  1015445000 04022536732596
                  1015449010 04022536706757

                  Documentation

                  Emprove Dossier

                  TitleVersion
                  10.0

                  Quality Management Dossier (Open Access)

                  Title

                  Operational Excellence Dossier

                  Title

                  Monoclorhidrat de L-arginina MSDS

                  Title

                  Safety Data Sheet (SDS) 

                  Monoclorhidrat de L-arginina Certificates of Analysis

                  Product Number PackagingSpecificationLot Number
                  1015440001 Plastic bottlePDF Specification Document
                  1015441000 Plastic bottlePDF Specification Document
                  1015445000 Plastic drumPDF Specification Document
                  1015449010 Plastic drumPDF Specification Document

                  Certificates

                  Title