Dexamethasone Sodium Phosphate Compounded Injection

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

Dexamethasone Sodium Phosphate Compounded Injection contains NLT 90.0% and NMT 115.0% of the labeled amount of dexamethasone phosphate (C₂₂H₃₀FO₈P), present as the disodium salt. It contains no bacteriostat or other preservative.

Prepare Dexamethasone Sodium Phosphate Compounded Injection, 24 mg/mL, as follows (see Pharmaceutical Compounding-Sterile Preparations (797)).

^a Calculate the amount of dexamethasone sodium phosphate based on the water content stated on the certificate of analysis.

Dissolve the Dexamethasone Sodium Phosphate, Sodium Citrate Dihydrate, and Sodium Bisulfite in about 8 mL of Sterile Water for Injection.

Adjust with Sodium Hydroxide 10% solution to a pH of 7.4. Add sufficient Sterile Water for Injection to bring to final volume and mix well. Pass through a sterile filter of 0.22-µm pore size into sterile containers.

2 ASSAY

2.1 PROCEDURE

Solution A: Dissolve 6.8 g of monobasic potassium phosphate in 1000 ml of water and adjust with 6 N potassium hydroxide to a pH of 9.

Solution B: Acetonitrile and methanol (50:50)

Mobile phase: See Table 1.

Table 1

Diluent: Acetonitrile and water (25:75)

Standard solution: 0.12 mg/mL of dexamethasone phosphate prepared from USP Dexamethasone Sodium Phosphate RS in Diluent

Sample solution: Transfer 0.5 mL of the Injection to a 100-mL volumetric flask and dilute with Diluent to volume.

2.1.1 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 242 nm

Column: 4.6-mm x 15-cm; 5-µm packing L1

Flow rate: 1.0 mL/min

Injection volume: 15 µL

2.1.2 System suitability

Sample: Standard solution

[NOTE-The retention time for dexamethasone phosphate is about 15.4 min.)

2.1.3 Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dexamethasone phosphate (C₂₂H₃₀FO₈P) in the portion of Injection taken:

                Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response of dexamethasone phosphate from the Sample solution U

r_S = peak response of dexamethasone phosphate from the Standard solution

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

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

Acceptance criteria: 90.0%-115.0%

3 SPECIFIC TESTS

PH(791): 7.0-8.0

STERILITY TESTS (71): Meets the requirements

BACTERIAL ENDOTOXINS TEST (85): NMT 31.3 USP Endotoxin Units/mg of dexamethasone phosphate

PARTICULATE MATTER IN INJECTIONS (788): Meets the requirements

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in light-resistant single-dose containers. Store at controlled room temperature.

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 90 days after the date on which it was compounded when stored at controlled room temperature.

LABELING: Label it to indicate that it is a single-dose container and to state the Beyond-Use Date. Label to state that it should be protected from light.

USP REFERENCE STANDARDS (11)

USP Dexamethasone Sodium Phosphate RS