L(+)-Cysteine hydrochloride monohydrate 98.5-101.0% (alkalimetric, calculated on anhydrous substance), EMPROVE® ESSENTIAL Ph. Eur., USP, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
Warning

Synonyms: (R)-(+)-Cysteine hydrochloride monohydrate, (R)-2-Amino-3-mercaptopropanoic acid hydrochloride hydrate, L-Cysteine HCI Monohydrate, H-Cys-OH.HCl.H2O, Cysteine Hydrochloride, Monohydrate, Cysteine Hydrochloride monohydrate

1.02735.0100 1.02735.1000 1.02735.9010
1.02735.0100EA 142 GBP
1.02735.0100 1.02735.1000 1.02735.9010
L(+)-Cysteine hydrochloride monohydrate 98.5-101.0% (alkalimetric, calculated on anhydrous substance), EMPROVE® ESSENTIAL Ph. Eur., USP, SAFC®
L(+)-Cysteine hydrochloride monohydrate

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 (*).

Formula: HSCH₂CH(NH₂)COOH·HCl·H₂O
MW: 175,64 g/mol
Melting Pt: 168…170 °C
Density: 1,54 g/cm³
Storage Temperature: Ambient
MDL Number: MFCD00065606
CAS Number: 7048-04-6
EINECS: 200-157-7
Merck Index: 13,02810
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Specification Test Results

Assay (Iodometric, calc. on Dried Substance) 98.5-101.0%
Ammonium (NH4) Max. 0.02%
Appearance White Crystalline Powder or Colorless Crystals
Appearance of Solution (25 g/l, water) Clear and no more Intense in Color than BY6
Heavy metals (as Pb) Max 0.001%
Identity (IR-spectrum) Passes test
Iron (Fe) Max. 0.002%
Loss on Drying (Vacuum) Max. 12.0%
Ninhydrin-Positive Substances (TLC) Max. 0.5%
Organic Volatile Impurities (According to USP) Conforms
Residual Solvents (Ph.Eur./ICH) Excluded by Manufacturing Process
Specific Rotation [a]20/D; 80 g/l; HCl 250 g/l, Dried +5.5 - +7.0°
Specific rotation [a]25/D; 80g/l; HCl 6mol/l, Dried +5.7 - +6.8°
Sulfate (SO4) Max. 0.03%
Sulfated ash (600 °C) Max. 0.1%
Corresponds to Ph. Eur., USP

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