Cysteine Hydrochloride Injection
»Cysteine Hydrochloride Injection is a sterile solution of Cysteine Hydrochloride in Water for Injection.It contains not less than 85.0percent and not more than 115.0percent of the labeled amount of C3H7NO2S·HCl·H2O.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
USP Reference standards á11ñ USPL-Cysteine Hydrochloride RS.USP Endotoxin RS.
Identification—
A: To 2mLof Injection add 3mLof water,and mix.Add 10mLof cupric sulfate TS:a bluish-gray precipitate is formed.
B: To 2mLof Injection add 3mLof water,and mix.Add 2mLof 3Nsodium hydroxide and 2drops of sodium nitroferricyanide solution (1in 20):a red-purple color is produced,and it rapidly changes to yellow.
Bacterial endotoxins á85ñ It contains not more than 0.7USP Endotoxin Unit per mg of cysteine hydrochloride.
pHá791ñ: between 1.0and 2.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Standard solution— Dissolve an accurately weighed quantity of USPL-Cysteine Hydrochloride RSin nitrogen-saturated water to obtain a solution having a known concentration of about 1mg per mL.
Standard preparation— Transfer 20.0mLof Standard solutionto a 200-mLvolumetric flask,dilute with nitrogen-saturated 1.0Nsodium hydroxide to volume,and mix.
Assay preparation— Dilute an accurately measured volume of Injection,equivalent to about 250mg of cysteine hydrochloride,quantitatively and stepwise with nitrogen-saturated 1.0Nsodium hydroxide,to obtain a solution having a concentration of about 0.1mg per mL.
Procedure— Transfer a suitable amount of Standard preparationto a polarographic cell.With mercury dropping from the electrode,lower the dropping mercury electrode of a polarograph so that the end is submerged in the liquid.Bubble oxygen-free,water-saturated nitrogen through the liquid for 15minutes.Record the polarogram from -0.2volt to -1.10volts,using a saturated calomel electrode as the reference electrode.In a similar manner,record the polarograms obtained using portions of the Assay preparationand of the nitrogen-saturated 1.0Nsodium hydroxide.Determine the height of the diffusion current wave at -0.4volt.Calculate the quantity,in mg,of C3H7NO2S·HCl·H2Oin each mLof the Injection taken by the formula:
2500(C/V)[(id)U/(id)S],
in which Cis the concentration,in mg per mL,of USPL-Cysteine Hydrochloride RS.In the Standard preparation,Vis the volume,in mL,of Injection taken;and (id)Uand (id)Sare the observed diffusion currents,corrected for the diffusion current of the 0.1Nsodium hydroxide,of the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 566
Phone Number:1-301-816-8389