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L-CYSTEINE HCL MONOHYDRATE - DFI-223899

Published:10/06/2019

Description

CAS No.7048-04-6
E numberE920
AppearanceWhite crystal or crystalline powder
Appearance(of solution)Clear and not more intensely coloured than reference solution BY6.
Storage(EP,USP,FCC)Preserve in well-closed,light resistant containers.
Shelf life24 months
Country of originChina

Specification

Identificationas per EP,USP,FCC
Solubilityfreely soluble in water and in ethanol
Specific Rotation([a] 20D FCC)+5.0° to +8.0°
Specific Rotation([a] 25 D USP)+5.7° to +6.8 °
Specific Optical Rotation(EP)+5.5 to +7.0°
Loss on drying(FCC,USP)8.00~ 12.00%
Residue on ignition(FCC)<=0.4%
Lead(FCC)<= 5 mg/kg, ppm
Assay(FCC,USP)98.0%~101.5%
Sulphate (SO4)(USP)<=0.03%
Sulphate(s EP)<=300 ppm, mg/kg
Iron (Fe)(USP)<=30 ppm, mg/kg
Iron (Fe)(EP)<= 20 ppm, mg/kg
Heavy metals(USP,EP)<=15 ppm, mg/kg
Impurities(Total USP)<=2.0%
Impurities(Individual USP)<=0.5%
Impurity A(EP)<=0.5%
Impurities(each EP)<=1.0%
Impurities(total)<=1.0%
Sulphated ash(EP)<=0.1%
Ammonium(EP)<=200 ppm, mg/kg
Chloride (Cl)((HCL)USP/FCC)19.89~21.29%
Residue on ignition(USP)<= 0.10%

Microbiological

Aerobic Plate Count(FCC,USP,EP)<1000 cfu/g
Coliforms(EP,USP,FCC)Negative in 1 g
Escherichia Coli(EP,USP,FCC)Negative in 1g
Yeasts(EP,USP,FCC)< 50 cfu/g
Moulds(EP,USP,FCC)<50 cfu/g
Salmonella(EP,USP,FCC)Negative/375g
Staphylococcus aureus(EP,USP,FCC)Negative/25g

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