Chlorambucil 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 

Chlorambucil Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of chlorambucil (C₁₄H₁₉Cl₂NO₂).

Prepare Chlorambucil Compounded Oral Suspension 2 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉). 

^a Chlorambucil 2-mg tablets, GlaxoSmithKline, Research Triangle Park, NC. 

^b Perrigo, Allegan, MI. 

Place the Chlorambucil tablets into a suitable container and triturate to a fine powder. Add a small amount of Vehicle to form a smooth paste. Add a sufficient amount of Vehicle to make the contents pourable. Transfer contents stepwise and quantitatively to a calibrated container using the remainder of the Vehicle. Add sufficient Vehicle to bring to nal volume. Shake to mix well. 

2 ASSAY 

Procedure 

Solution A: 0.2% (v/v) glacial acetic acid in water 

Mobile phase: Methanol and Solution A (65:35) 

Standard solution: 0.2 mg/mL of USP Chlorambucil RS in methanol 

Sample solution: Transfer 1.0 mL of Oral Suspension into a 10-mL volumetric flask, add methanol to volume, and filter. [Note—The Standard solution and the Sample solution must be used within 6 h of preparation.] 

Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 258 nm 

Column: 4.6-mm × 25-cm; 5-µm packing L1 

Temperatures 

Autosampler: 15° 

Column: 40° 

Flow rate: 2.0 mL/min 

Injection volume: 25 µL 

System suitability 

Sample: Standard solution 

[Note—The retention time for chlorambucil is about 3.6 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 chlorambucil (C₁₄H₁₉Cl₂NO₂) in the portion of Oral Suspension taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response of chlorambucil from the Sample solution 

r_S = peak response of chlorambucil from the Standard solution 

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

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

Acceptance criteria: 90.0%–110.0% 

3 SPECIFIC TESTS 

pH 〈791〉: 3.5–4.5 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator. 

Beyond-Use Date: NMT 14 days after the day on which it was compounded when stored in a refrigerator 

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

USP Reference Standards 〈11〉 

USP Chlorambucil RS