L(+)-Cysteine hydrochloride monohydrate 98.5-101.0% (alkalimetric, calculated on anhydrous substance), EMPROVE® ESSENTIAL Ph. Eur., USP, SAFC®
Supplier: MilliporeSigma
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Warning
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Synonyms:
(R)-2-Amino-3-mercaptopropanoic acid hydrochloride hydrate
, (R)-(+)-Cysteine hydrochloride monohydrate
, L-Cysteine HCI Monohydrate
, Cysteine Hydrochloride monohydrate
, H-Cys-OH.HCl.H2O
, 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 |
MDL Number:
MFCD00065606 CAS Number: 7048-04-6 Merck Index: 13,02810 |
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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