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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Hydrochlorothiazide Compounded Oral Suspension 

1 DEFINITION 

Hydrochlorothiazide Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of hydrochlorothiazide (C₇H₈ClN₃O₄S₂). 

Prepare Hydrochlorothiazide Compounded Oral Suspension 2.5 mg/mL and 10 mg/mL as follows (see Pharmaceutical Compounding— Nonsterile Preparations 〈795〉). 

For Hydrochlorothiazide Compounded Oral Suspension Containing 2.5 mg/mL 

^a Perrigo, Allergan, MI. 

For Hydrochlorothiazide Compounded Oral Suspension Containing 10mg/mL 

^a Perrigo, Allergan, MI. 

Place the Hydrochlorothiazide powder in 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 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 nal volume. Shake to mix well. 

2 ASSAY 

Procedure 

Solution A: 80 mM of monobasic sodium phosphate monohydrate adjusted with phosphoric acid to a pH of 2.9 Solution B: Methanol and water (20:80) 

Mobile phase: See Table 1. 

Table 1 

Standard solution: Transfer 20 mg of USP Hydrochlorothiazide RS to a 200-mL volumetric flask. Add 40 mL of methanol and sonicate for 20 min. Dilute with water to volume and mix. 

Sample solution 

For Oral Suspension 2.5 mg/mL: Transfer 2 mL of Oral Suspension to a 50-mL volumetric flask, add 10 mL of methanol, and sonicate for 20 min. Dilute with water to volume and mix. Centrifuge an aliquot for 10 min and transfer the supernatant to an HPLC vial. For Oral Suspension 10 mg/mL: Transfer 1 mL of Oral Suspension to a 100-mL volumetric flask, add 20 mL of methanol, and sonicate for 20 min. Dilute with water to volume and mix. Centrifuge an aliquot for 10 min and transfer the supernatant to an HPLC vial. Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 227 nm 

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

Temperatures 

Autosampler: 4° 

Column: 25° 

Flow rate: 2.0 mL/min 

Injection volume: 15 µL 

System suitability 

Sample: Standard solution 

[Note—The retention time for hydrochlorothiazide is about 4.8 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 hydrochlorothiazide (C₇H₈ClN₃O₄S₂) in the portion of Oral Suspension taken: 

Result = (r_U/r_S) × (C_S/C_U) × 100 

r_U = peak response of hydrochlorothiazide from the Sample solution  

r_S = peak response of hydrochlorothiazide from the Standard solution 

C_S = concentration of USP Hydrochlorothiazide RS in the Standard solution (µg/mL) 

C_U = nominal concentration of hydrochlorothiazide in the Sample solution (µg/mL) 

Acceptance criteria: 90.0%–110.0% 

3 SPECIFIC TESTS 

pH 〈791〉: 3.7–4.7 

4 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Package in tight, light-resistant containers. Store in a refrigerator or at controlled room temperature. Beyond-Use Date: NMT 90 days after the date on which it was compounded, when stored in a refrigerator or at controlled room temperature 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 Hydrochlorothiazide RS