Stavudine for Oral Solution

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

Stavudine for Oral Solution, when reconstituted as directed in the labeling, yields a 1 mg/mL solution that contains NLT 90.0% and NMT 110.0% of the labeled amount of stavudine). It may contain suitable flavors, preservatives, sweeteners, and stabilizers.

2 IDENTIFICATION

Change to read:

A. (USP 1-Aug-2019) The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

Add the following:

B. The UV spectrum of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP 1-Aug-2019)

3 ASSAY

Change to read:

Procedure

[Note—All testing solutions must be prepared immediately before use and remain refrigerated until use.]

Buffer: 1.93 mg/mL of ammonium acetate in water

Solution A: Methanol and Buffer (6:94)

Solution B: Methanol and Buffer (1:1)

Mobile phase: See Table 1.

Table 1

System suitability solution: 2.5 μg/mL each of USP Zidovudine Related Compound C RS (USP 1-Aug-2019) and USP Zidovudine Related

Compound D RS (USP 1-Aug-2019) in water

Standard solution: 0.1 mg/mL of USP Stavudine RS in water

Sample solution: Nominally 0.1 mg/mL of stavudine in water, prepared as follows. Constitute Stavudine for Oral Solution as directed in the labeling. Dilute an accurately measured volume of Stavudine for Oral Solution quantitatively, and stepwise if necessary, with water.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 268 nm. For Identification B, use a diode array detector in the range of 200–400 nm. (USP 1-Aug-2019)

Columns

Guard: 4-mm × 20-mm; 5-μm (USP 1-Aug-2019) packing L1

Analytical: 4.6-mm × 3.3-cm; 3-μm (USP 1-Aug-2019) packing L1

Flow rate: 1 mL/min

Injection volume: 20 μL

System suitability

Samples: System suitability solution and Standard solution

Suitability requirements

Resolution: NLT 8.4 between zidovudine related compound C (USP 1-Aug-2019) and zidovudine related compound D, (USP 1-Aug-2019)

System suitability solution

(USP 1-Aug-2019)

Tailing factor: NMT 2 for the stavudine peak, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of stavudine (C₁₀H₁₂N₂O₄) in each milliliter of Stavudine for Oral Solution taken:

Result = (r_U/r_S) × (C_S/C_U) × 100

r_U = peak area from the Sample solution

r_S = peak area from the Standard solution

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

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

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Deliverable Volume 〈698〉: Meets the requirements

5 IMPURITIES

Change to read:

Organic Impurities

[Note—All testing solutions must be prepared immediately prior to use and remain refrigerated until use.]

Buffer, (USP 1-Aug-2019) Solution A, Solution B, Mobile phase, (USP 1-Aug-2019) System suitability solution, Standard solution, Sample

solution, Chromatographic system, and System suitability: (USP 1-Aug-2019) Proceed as directed in the Assay.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each impurity in the portion of Stavudine for Oral Solution taken:

Result = (r_U/r_T) × 1/F × 100

r_U = peak response of each impurity from the Sample solution

r_T = sum of all the peak responses including that of the main stavudine peak from the Sample solution

F = relative response factor (see Table 2)

Acceptance criteria: See Table 2.

Table 2

^a 5-Methylpyrimidine-2,4-(1H,3H)-dione.

6 SPECIFIC TESTS

pH 〈791〉

Sample: Constitute as directed in the labeling.

Acceptance criteria: 5–7

Water Determination 〈921〉, Method I: NMT 2.0%

7 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tightly closed containers, protected from excessive moisture. Store at controlled room temperature. After constitution, store the Stavudine for Oral Solution in tightly closed containers under refrigeration. Discard unused portion after 30 days.

Labeling: The label contains directions for constitution of the powder and states the equivalent amount of stavudine in a given volume of the Stavudine for Oral Solution obtained after constitution.

Change to read:

USP Reference Standards 〈11〉

USP Stavudine RS

USP Zidovudine Related Compound C RS