Biotin 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

Biotin Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of biotin (C₁₀H₁₆N₂O₃S).

Prepare Biotin Compounded Oral Suspension 10 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉):

a Perrigo Pharmaceuticals, Allegan, MI.

Place the Biotin powder in a suitable container and triturate to a fine powder. Add a small amount of Vehicle and mix well to form a smooth paste. Add a sufficient amount of Vehicle to make the mortar contents pourable. Transfer the contents stepwise and quantitatively to a calibrated container using the remainder of the Vehicle. Add sufficient Vehicle to bring to final volume. Mix well.

2 ASSAY

Procedure

Solution A: Add 1 g of sodium perchlorate monohydrate to 500 mL of water. Add 1 mL of phosphoric acid and then an additional 500 mL of water.

Mobile phase: Acetonitrile and Solution A (8.5:91.5)

Diluent: Acetonitrile and water (20:80)

Standard solution: 0.1 mg/mL of USP Biotin RS in Diluent

Sample solution: Transfer 1.0 mL of Oral Suspension into a 100-mL volumetric flask, and add Diluent to volume. Pass through a filter of 0.22-µm pore size.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 200 nm

Column: 4.6-mm × 15-cm; 3.5-µm packing L7

Flow rate: 1.2 mL/min

Injection volume: 50 µL

System suitability

Sample: Standard solution

[Note—The retention time for biotin is about 11.8 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 biotin (C₁₀H₁₆N₂O₃S) in the portion of Oral Suspension taken:

Result = (rᵤ/rₛ) × (Cₛ/Cᵤ) × 100

rᵤ = peak response of biotin from the Sample solution

rₛ = peak response of biotin from the Standard solution

Cₛ = concentration of USP Biotin RS in the Standard solution (mg/mL)

Cᵤ = nominal concentration of biotin in the Sample solution (mg/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 at controlled room temperature or in a refrigerator.

Beyond-Use Date: NMT 90 days after the date on which it was compounded when stored at controlled room temperature or 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 Biotin RS