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102735 L-Cysteine hydrochloride monohydrate

EMPROVE® EXPERT Ph Eur,JP,USP

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

Synonyms: Cys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate

CAS #: 7048-04-6 EC Number: 200-157-7 Molar Mass: 175.60 g/mol Hill Formula: C₃H₈ClNO₂S * H₂O Grade: Ph Eur,JP,USP
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102735
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberHill FormulaMolar MassGrade Value
7048-04-6200-157-7C₃H₈ClNO₂S * H₂O175.60 g/molPh Eur,JP,USP

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          1.02735.9010
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              Description
              Catalogue Number102735
              SynonymsCys, L-Cysteinium Chloride Monohydrate, L-Cysteine Hydrochloride, Monohydrate
              References
              Product Information
              CAS number7048-04-6
              EC number200-157-7
              GradePh Eur,JP,USP
              Hill FormulaC₃H₈ClNO₂S * H₂O
              Molar Mass175.60 g/mol
              HS Code2930 90 12
              Structure formula ImageStructure formula Image
              Quality LevelMQ500
              Applications
              Biological Information
              Physicochemical Information
              Density1.51 g/cm3
              Melting Point176 °C
              pH value0.8 - 1.2 (100 g/l, H₂O, 20 °C)
              Vapor pressure<0.1 hPa (20 °C)
              Bulk density780 kg/m3
              Solubility650 g/l
              Dimensions
              Materials Information
              Toxicological Information
              Safety Information according to GHS
              RTECSHA2285000
              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 (alkalimetric, calculated on dried substance)98.5 - 101.0 %
              Identity (IR-spectrum)passes test
              Identity (specific rotation)passes test
              Identity (wet chemistry)passes test
              Appearancewhite to almost white crystalline powder or colorless crystals
              Appearance of solution (25 g/l, water)clear and not more intense in color than reference solution BY₆
              Appearance of solution (100 g/l, water)clear and colorless
              pH (10 g/l, CO₂-free water)1.3 - 2.3
              Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 250 g/l, calc. on dried substance)+5.5 to +7.0
              Spec. rotation (α 25/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+5.7 to +6.8
              Spec. rotation (α 20/D, 80 g/l, hydrochloric acid 6 mol/l, calc. on dried substance)+6.0 to +7.5
              Sulfate (SO₄)≤ 200 ppm
              Heavy metals (as Pb)≤ 10 ppm
              Fe (Iron)≤ 10 ppm
              Related substances (TLC)passes test
              Related Compounds, total (TLC)≤ 0.5 %
              Ninhydrin-positive substances (LC) (impurity A (570 nm))≤ 0.5 %
              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)≤ 1.0 %
              Residual solvents (ICH Q3C)excluded by manufacturing proces
              Sulfated ash (600 °C)≤ 0.1 %
              Loss on drying (Vacuum < 2,0 kPa, P2O5, 20 h)8.5 - 12.0 %
              Bacterial endotoxins≤ 6.0 I.U./g
              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.
              Global Trade Item Number
              Catalogue Number GTIN
              1.02735.0100 04022536942612
              1.02735.1000 04022536942629
              1.02735.9010 04022536942636

              Documentation

              Material Qualification Dossier

              TitleVersion
              9.0

              Quality Management Dossier (Open Access)

              Title

              Operational Excellence Dossier

              Title

              L-Cysteine hydrochloride monohydrate SDS

              Title

              Safety Data Sheet (SDS) 

              L-Cysteine hydrochloride monohydrate Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1.02735.0100 Plastic bottlePDF Specification Document
              1.02735.1000 Plastic bottlePDF Specification Document
              1.02735.9010 Plastic drumPDF Specification Document

              Certificates

              Title

              Brochure

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