Bacteriostatic Sodium Chloride Injection
»Bacteriostatic Sodium Chloride Injection is a sterile,isotonic solution of Sodium Chloride in Water for Injection,and it contains one or more suitable antimicrobial agents.It contains not less than 0.85percent and not more than 0.95percent of NaCl.
NOTE—Use Bacteriostatic Sodium Chloride Injection with due regard for the compatibility of the antimicrobial agent or agents it contains with the particular medicinal substance that is to be dissolved or diluted.
Packaging and storage— Preserve in single-dose or multiple-dose containers,of not larger than 30-mLsize,preferably of Type Ior Type IIglass.
Labeling— Label it to indicate the name(s)and proportion(s)of the added antimicrobial agent(s).Label it also to include the statement “NOT FOR USE IN NEWBORNS”in boldface capital letters,on the label immediately under the official name,printed in a contrasting color,preferably red.Alternatively,the statement may be placed prominently elsewhere on the label if the statement is enclosed within a box.Label it also to include the statement “NOT FOR INHALATION.”
Antimicrobial agent(s)— It meets the requirements under Antimicrobial Preservatives—Effectiveness á51ñ,and meets the labeled claim for content of the antimicrobial agent(s)as determined by the method set forth under Antimicrobial Agents—Content á341ñ,except to use the following procedure when methylparaben and propylparaben are used as the antimicrobial agents.
Mobile phase— Prepare a filtered and degassed mixture of methanol and water (70:30).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Dissolve accurately weighed quantities of USP Methylparaben RSand USP Propylparaben RSin methanol,and dilute quantitatively,and stepwise if necessary,with methanol to obtain a solution having known concentrations of about 1.2and 0.12mg per mL,respectively.Pipet 5mLof this solution into a 50-mLvolumetric flask,add by pipet 30mLof methanol,dilute with water to volume,and mix.
Test preparation— Pipet 1mLof Injection into a 10-mLvolumetric flask,add by pipet 7mLof methanol,dilute with water to volume,and mix.
Chromatographic system (see Chromatography á621ñ)—The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×30-cm column that contains packing L1.The flow rate is about 1.5mLper minute.Chromatograph the Standard preparationas directed for Procedure:the capacity factor,k¢,is 0.52for methylparaben and 1.05for propylparaben,with a minimum separation factor (a)of about 2.0.
Procedure— Separately inject equal volumes (about 12µL)of the Standard preparationand the Test preparationinto the chromatograph by means of a suitable microsyringe or sampling valve,adjusting the specimen size and other operating parameters such that the peak obtained with the Standard preparationis about 0.7full scale.Record the chromatograms,and measure the height of the peaks,at identical retention times,obtained with the Test preparationand the Standard preparation,and calculate the concentration in mg per mL,in the portion of methylparaben or propylparaben taken by the formula:
C(HU/HS),
in which Cis the concentration,in mg per mL,of USP Methylparaben RSor USP Propylparaben RSin the Standard preparation;and HUand HSare the peak heights obtained from the Test preparationand the Standard preparation,respectively.
Bacterial endotoxins á85ñ— It contains not more than 1.0USP Endotoxin Unit per mL.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It responds to the Identificationtest and meets the requirements for pH,Iron,Heavy metals,and Assayunder Sodium Chloride Injection.It meets also the requirements under Injections á1ñ.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1780
Phone Number:1-301-816-8379