Carboxymethylcellulose Sodium Compounded Intraperitoneal Solution, Veterinary

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Carboxymethylcellulose Sodium Compounded Intraperitoneal Solution, Veterinary contains NLT 80.0% and NMT 120.0% of the labeled amount of carboxymethylcellulose sodium (C₈H₁₅NaO₈). Prepare Carboxymethylcellulose Sodium Compounded Intraperitoneal Solution, Veterinary 10 mg/mL (1%) as follows (see Pharmaceutical Compounding-Sterile Preparations (797)).

^a High-viscosity carboxymethylcellulose sodium must be used.

Wet the Carboxymethylcellulose Sodium with the Propylene Glycol in a suitable container. Place 450 mL of Sterile Water for Injection in a calibrated container on a hot plate with a stir bar and heat to NMT 100° (do not allow to boil). Add the Carboxymethylcellulose Sodium and Propylene Glycol mixture to heated Sterile Water for Injection by pouring along the outer edge of the water level and not directly into the vortex created by the stir bar to avoid clumping. Continue heating and stirring to facilitate complete dissolution of the Carboxymethylcellulose Sodium. [NOTE-This may take 30-60 min to completely dissolve.] Once completely dissolved, bring to final volume with Sterile Water for Injection. Transfer to a 500-mL high-density polyethylene (HDPE) plastic single-dose container suitable for autoclaving and crimp seals tightly before autoclaving. Sterilize by autoclaving.

2 ASSAY

PROCEDURE

Mobile phase: 0.052% (v/v) methanesulfonic acid

Diluent: 0.52% (v/v) methanesulfonic acid

Standard solution: 0.03 mg/mL of sodium prepared by mixing USP Sodium Chloride RS and water

Sample solution: Transfer 1 mL of Intraperitoneal Solution, Veterinary into a 25-mL volumetric flask and dilute with Diluent to volume.

[NOTE-The Standard solution and Sample solution are stable for only 24 h.]

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Conductivity

Column: 4.0-mm x 25-cm; packing L77

Column temperature: 15°

Flow rate: 1.0 mL/min

Injection volume: 10 µL

System suitability

Sample: Standard solution

[NOTE-The retention time for sodium is about 3.3 min.]

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sodium (Na) in the portion of Intraperitoneal Solution, Veterinary:

Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of sodium from the Sample solution

r_S = peak response of sodium from the Standard solution

C_S = concentration of sodium in the Standard solution (mg/mL)

C_U = nominal concentration of sodium in the Sample solution (mg/mL)

Acceptance criteria: 80.0%–120.0%

3 SPECIFIC TESTS

pH 〈791〉: 6.7–7.7

Sterility Tests 〈71〉, Test for Sterility of the Product to Be Examined, Direct Inoculation of the Culture Medium: Meets the requirements

Bacterial Endotoxins Test 〈85〉: NMT 1.75 USP Endotoxin Units/mL of carboxymethylcellulose sodium

Viscosity—Rotational Methods 〈912〉

Sample: 5 mL of Intraperitoneal Solution, Veterinary

Analysis: Determine at 25° by using a rotational viscometer.

Acceptance criteria: Between 600 and 1,200 centipoises

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in 500-mL autoclavable HDPE plastic containers. Store at controlled room temperature.

Labeling: Label it to indicate to state the Beyond-Use Date.

Change to read:

Beyond-Use Date: In the absence of performing and completing a sterility and endotoxin test, the storage conditions in Pharmaceutical

Compounding – Sterile Preparations 〈797〉, 14.3 Establishing a BUD for a CSP apply. (CN 1-Nov-2023) After successful completion of sterility and endotoxin testing, NMT 60 days after the day on which it was compounded when stored at controlled room temperature.

USP Reference Standards 〈11〉

USP Sodium Chloride RS