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102735 L-Cysteine hydrochloride monohydrate

Overview

Replacement Information

Key Specifications Table

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

Products

Catalog NumberPackaging Qty/Pack
1027350001 Fibre case 3 x 1 kg
1027350100 Plastic bottle 100 g
1027351000 Plastic bottle 1 kg
1027359010 Plastic drum 10 kg
1027359025 Plastic drum 25 kg
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
Catalog Number GTIN
1027350001 04054839392191
1027350100 04022536942612
1027351000 04022536942629
1027359010 04022536942636
1027359025 04054839392207

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
1027350001 Fibre casePDF Specification Document
1027350100 Plastic bottlePDF Specification Document
1027351000 Plastic bottlePDF Specification Document
1027359010 Plastic drumPDF Specification Document
1027359025 Plastic drumPDF Specification Document

Certificates

Title

Technical Info

Title
1.02735 Change Notification Letter