Bacteriostatic Sodium Chloride Injection
DEFINITION
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 NLT 0.85% and NMT 0.95% 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. ]
IDENTIFICATION
• Identification Tests—General, Sodium 
191
and Chloride 191: Meets the requirements
191 and Chloride 191: Meets the requirementsASSAY
• Procedure
Sample solution: Equivalent to 90 mg of sodium chloride from the volume of Injection. 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 NaCl.
Acceptance criteria: 0.85%–0.95%
IMPURITIES
Inorganic Impurities
• Iron 241
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
• Heavy Metals, Method I 231
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 20 mL, add 2 mL of 1 N acetic acid, then dilute with water to 25 mL.
Analysis: 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
SPECIFIC TESTS
• Antimicrobial Agent(s): It meets the requirements under Antimicrobial Effectiveness Testing 51, and meets the labeled claim for content of the antimicrobial agent(s) as determined by the method set forth under Antimicrobial Agents—Content 341, except use the following procedure when methylparaben and propylparaben are used as the antimicrobial agents.
51, and meets the labeled claim for content of the antimicrobial agent(s) as determined by the method set forth under Antimicrobial Agents—Content 341, except use the following procedure when methylparaben and propylparaben are used as the antimicrobial agents.Mobile phase: Methanol and water (7:3)
Standard stock solution: 1.2 mg/mL of USP Methylparaben RS and 0.12 mg/mL of USP Propylparaben RS in methanol
Standard solution: Pipet 5 mL of the Standard stock solution into a 50-mL volumetric flask, add by pipet 30 mL of methanol, and dilute with water to volume.
Sample solution: Pipet 1 mL of Injection into a 10-mL volumetric flask, add by pipet 7.0 mL of methanol, and dilute with water to volume.
Chromatographic system
Mode: LC
Detector: UV 254 nm
Column: 4-mm × 30-cm; packing L1
Flow rate: 1.5 mL/min
Injection size: 12 µL
System suitability
Sample: Standard solution
Suitability requirements
Capacity factor: 0.52 for methylparaben and 1.05 for propylparaben
Resolution: NLT 2.0 between the methylparaben and propylparaben peaks
Analysis
Samples: Standard solution and Sample solution
Calculate the concentration, in mg/mL, of methylparaben or propylparaben in the portion of Injection taken:
Result = (rU/rS) × CS
| rU | = | = peak height from the Sample solution |
| rS | = | = peak height from the Standard solution |
| CS | = | = concentration of USP Methylparaben RS or USP Propylparaben RS in the Standard solution (mg/mL) |
• Particulate Matter in Injections 788: Meets the requirements for small-volume injections
788: Meets the requirements for small-volume injections• pH 791: 4.5–7.0
791: 4.5–7.0• Bacterial Endotoxins Test 85: NMT 1.0 USP Endotoxin Unit/mL
85: NMT 1.0 USP Endotoxin Unit/mL• Other Requirements: It meets the requirements under Injections 1.
1.ADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in single-dose or multiple-dose containers, of not larger than 30-mL size, preferably of Type I or Type II glass.
• 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.
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Auxiliary Information— Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Domenick Vicchio, Ph.D. Senior Scientific Liaison 1-301-998-6828 | (SM42010) Monographs - Small Molecules 4 |
| 85 | Radhakrishna S Tirumalai, Ph.D. Principal Scientific Liaison 1-301-816-8339 | (GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4654
Pharmacopeial Forum: Volume No. 36(2) Page 431Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.