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101544 L-Arginín monohydrochlorid

vhodný na použitie ako excipient EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP

L-Arginín monohydrochlorid 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
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

Products

Catalogue NumberPackaging Qty/Pack
1015440001 Plastová flaša 3 x 1 kg
1015441000 Plastová flaša 1 kg
1015445000 Plastový sud 5 kg
1015449010 Plastový sud 10 kg
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 Potkan 12000 mg/kg
Safety Information according to GHS
RTECSCF1995500
Storage class10 - 13 Iné kvapaliny a tuhé látky
WGKWGK 1 mierne ohrozujúce vody
Disposal3
Relatívne nereaktívne organické reagencie je potrebné zhromaždovať v nádobe A. Ak sú halogénované, je potrebné ich zhromaždovať v nádobe B. Pre tuhé zvyšky použite nádobu C.
Safety Information
Product Usage Statements
Storage and Shipping Information
StorageSkladujte pri +2°C až +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

Material Qualification Dossier

TitleVersion
10.0

Quality Management Dossier (Open Access)

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Operational Excellence Dossier

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L-Arginín monohydrochlorid MSDS

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Safety Data Sheet (SDS) 

L-Arginín monohydrochlorid Certificates of Analysis

Product Number PackagingSpecificationLot Number
1015440001 Plastová flašaPDF Specification Document
1015441000 Plastová flašaPDF Specification Document
1015445000 Plastový sudPDF Specification Document
1015449010 Plastový sudPDF Specification Document

Certificates

Title