Cyclophosphamide Compounded Oral Suspension

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

Cyclophosphamide Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of cyclophosphamide (C₇H₁₅CI₂N₂O₂P).

Prepare Cyclophosphamide Compounded Oral Suspension 20 mg/mL as follows (see Pharmaceutical Compounding-Nonsterile Preparations (795)).

^a Cyclophosphamide 50-mg capsules, Roxane Laboratories, Inc., Columbus, OH.

^b Perrigo, Allegan, MI.

Empty the Cyclophosphamide capsules into a suitable container and triturate to a fine powder. Add a small amount of Ora-Blend and mix well to form a smooth paste. Add a sufficient amount of Ora-Blend to make the container contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the remainder of the Ora-Blend. Add sufficient Ora-Blend to bring to final volume. Mix well. [CAUTION-Cyclophosphamide is a hazardous drug and must be handled accordingly.]

2 ASSAY

2.1 PROCEDURE

Mobile phase: Add 2.34 g of monobasic potassium phosphate to 780 mL of water. Adjust with 6 N potassium hydroxide to a pH of 7.0. Add 220 mL of acetonitrile. Pass the solution through a filter of 0.22-µm pore size.

Standard solution: 0.4 mg/mL of cyclophosphamide prepared from USP Cyclophosphamide RS in water

Sample solution: Transfer 1.0 mL of Oral Suspension into a 50-mL volumetric flask and bring to final volume with water. Pass through a filter of 0.45-µm pore size.

2.2 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 205 nm

Column: 3.0-mm x 15-cm; 3-µm packing L1

2.3 Temperatures

Autosampler: 5"

Column: 45°

Flow rate: 0.5 mL/min

Injection volume: 5 µL

2.4 System suitability

Sample: Standard solution

[NOTE-The retention time for cyclophosphamide is about 8.1 min.]

2.5 Suitability requirements

Sample: Standard solution

[NOTE-The retention time for cyclophosphamide is about 8.1 min.]

2.6 Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% for replicate injections

2.7 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of cyclophosphamide (C₇H₁₅CI₂N₂O₂P) in the portion of Oral Suspension taken: 15

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

r_U = peak response of cyclophosphamide from the Sample solution

r_S = peak response of cyclophosphamide from the Standard solution

C_S = concentration of USP Cyclophosphamide RS in the Standard solution (mg/mL)

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

Acceptance criteria: 90.0%-110.0%

3 SPECIFIC TESTS

PH (791): 3.6-4.6

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Package in tight, light-resistant containers. Store in a refrigerator.

BEYOND-USE DATE: NMT 30 days after the date on which it was compounded when stored in a refrigerator

LABELING: Label it to state that it is to be well shaken before use, and to state the Beyond-Use Date.

USP REFERENCE STANDARDS (11)

USP Cyclophosphamide RS

2S (USP41)