Sodium Chloride Injection

DEFINITION

Sodium Chloride Injection is a sterile solution of Sodium Chloride in Water for Injection. It contains no antimicrobial agents. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl).

IDENTIFICATION

• A. Identification Tests—General, Sodium

191

and Chloride

191

: Meets the requirements

ASSAY

• Procedure

Sample solution: Transfer a volume of Injection, equivalent to 90 mg of sodium chloride, into a conical flask. Add water, if necessary, to bring the volume to 10 mL, and add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS.

Analysis: Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 5.844 mg of sodium chloride (NaCl).

Acceptance criteria: 95.0%–105.0%

IMPURITIES

• Iron

241

Test preparation: Dilute 5.0 mL of Injection with water to 45 mL, and add 2 mL of hydrochloric acid.

Acceptance criteria: NMT 2 ppm

Delete the following:

• Heavy Metals, Method I

231

Test preparation: Place a volume of Injection, equivalent to 1.0 g of sodium chloride, in a suitable vessel. If necessary, evaporate to a volume of about 20 mL.

Analysis: To the Test preparation add 2 mL of 1 N acetic acid, then dilute with water to 25 mL. Proceed as directed, except use 1 mL of Standard Lead Solution (10 µg of Pb) in the Standard Preparation and in the Monitor Preparation.

Acceptance criteria: NMT 10 ppm, based on the amount of sodium chloride

(Official 1-Dec-2015)

SPECIFIC TESTS

• pH

791

: 4.5–7.0

• Particulate Matter in Injections

788

: Meets the requirements

• Bacterial Endotoxins Test

: NMT 0.5 USP Endotoxin Unit/mL where the labeled amount of sodium chloride in the Injection is between 0.5% and 0.9%, and NMT 3.6 USP Endotoxin Units/mL where the labeled amount of sodium chloride in the Injection is between 3.0% and 24.3%

• Other Requirements: It meets the requirements in Injections

ADDITIONAL REQUIREMENTS

• Packaging and Storage: Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass.

• Labeling: The label states the total osmolar concentration in mOsmol/L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol/mL.

• USP Reference Standards

USP Endotoxin RS

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Mary P. Koleck, Ph.D. Scientific Liaison (301) 230-7420	(SM42010) Monographs - Small Molecules 4
85	Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison (301) 816-8339	(GCM2010) General Chapters - Microbiology
Reference Standards	RS Technical Services 1-301-816-8129 rstech@usp.org

USP38–NF33 Page 5314

Pharmacopeial Forum: Volume No. 27(4) Page 2777