L(+)-Cysteine hydrochloride monohydrate 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

Synonyms: (R)-2-Amino-3-mercaptopropanoic acid hydrochloride hydrate(R)-(+)-Cysteine hydrochloride monohydrateL-Cysteine HCI MonohydrateCysteine Hydrochloride monohydrateH-Cys-OH.HCl.H2OCysteine Hydrochloride, Monohydrate

Management of Change (MOC) category = R

BAKR2071-05 2071-06 2071-05 BAKR2071-06
CAJT2071-6EA 5483.17 CAD
CAJT2071-6 CAJT2071-5 JT2071-5 JT2071-6
L(+)-Cysteine hydrochloride monohydrate 98.5-101.5% (dry basis) USP, Multi-Compendial, J.T.Baker®
L(+)-Cysteine hydrochloride monohydrate

White Crystalline solid. Hygroscopic.

Formula: HSCH₂CH(NH₂)COOH·HCl·H₂O
MW: 175.64 g/mol
Melting Pt: 168…170 °C
MDL Number: MFCD00065606
CAS Number: 7048-04-6
Merck Index: 13,02810
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Specification Test Results

GMP Manufactured Product
Meets B.P. Chemical Specifications
Meets E.P. Chemical Specifications
Meets U.S.P Requirements
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
USP - Assay (C₃H₇NO₂S·HCl) (dried basis) 98.5 - 101.5 %
USP - Identification Passes Test
USP - Specific Rotation [Å]²⁵ ^D (+) 5.7 - 6.8 Degree
USP - Loss on Drying 8.0 - 12.0 %
USP - Residue on Ignition ≤0.1 %
USP - Sulfate (SO₄) ≤0.03 %
USP - Iron (Fe) ≤0.003 %
USP - Related Compounds - Individual Impurities ≤0.5 %
USP - Related Compounds - Total Impurities ≤2.0 %
EP/BP - Assay (C₃H₇NO₂S·HCl) (dried basis) 98.5 - 101.0 %
EP/BP - Identification A Passes Test
EP/BP - Identification B Passes Test
EP/BP - Identification E Passes Test
EP/BP - Appearance of Solution Passes Test
EP/BP - Specific Rotation [Å]²º^D (+) 5.5 - 7.0 Degree
EP/BP - Ninhydrin-Positive Substances - Impurity A ≤0.5 %
EP/BP-Ninhydrin-Positive Substances-Each ≤0.2 %
EP/BP-Ninhydrin-Positive Substances-Total Impurities ≤1.0 %
EP/BP - Sulfate (SO₄) ≤300 ppm
EP/BP - Ammonium (NH₄) ≤0.02 %
EP/BP - Iron (Fe) ≤20 ppm
EP/BP - Loss on Drying 8.0 - 12.0 %
EP/BP - Ash (sulfated) ≤0.1 %
Endotoxin Concentration, IU/mg, For Information Only
No Class 1,2,3 or other solvents are used or produced in the
manufacturing or purification of the product.
Metallic Residues: No metal catalysts or metal reagents, as defined by
EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of
this material.

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