Triazolam Tablets

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

Triazolam Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of triazolam (C₁₇H₁₂CI₂N₄).

2 IDENTIFICATION

Change to read:

A. (USP 1-A-2023) The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. _{(USP 1-Aug-2023)}

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-2023)}

3 ASSAY

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PROCEDURE

Solution A: 0.1% (v/v) formic acid in water

Solution B: Acetonitrile

Mobile phase: See Table 1.

Table 1

Diluent: Acetonitrile and water (45:55)

Standard solution: 5 µg/mL of USP Triazolam RS in Diluent. Sonicate to dissolve if necessary.

Sample solution: Nominally 5 µg/mL of triazolam from Tablets prepared as follows. Transfer an appropriate quantity of triazolam from finely.

powdered Tablets (NLT 20) to a suitable volumetric flask. Add 10% of the flask volume of water, mix by swirling, and allow to stand for 10 min. Vortex for 10 s, add 45% of flask volume of acetonitrile, shake using mechanical shaker for 10 min, dilute with water to volume, and mix well. Centrifuge and use the clear supernatant.

Chromatographic system

(See Chromatography (621), Systern Suitability.)

Mode: LC

Detector: UV 257 nm. For Identification B, use a diode array detector in the range of 200-400 nm.

Column: 4.6-mm × 10-cm; 3.5-µm packing L1

Column temperature: 35°

Flow rate: 1.2 mL/min

Injection volume: 50 µL

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 1.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of triazolam (C₁₇H₁₂CI₂N₄) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of triazolam from the Sample solution

r_s = peak response of triazolam from the Standard solution

C_s = concentration of USP Triazolam RS in the Standard solution (µg/mL)

C_u = nominal concentration of triazolam in the Sample solution (µg/mL)

 _{(USP 1-Aug-2023)}

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

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DISSOLUTION (711)

Medium: Water: 500 mL

Apparatus 2: 50 rpm

Time: 30 min

Standard solution: (L/500) mg/mL of USP Triazolam RS, where L is the label claim of triazolam in mg/Tablet _{(ERR 1-Aug-2023)}, prepared as follows. For each 0.125 mg of the labeled amount of triazolam/Tablet, add 2.0 mL of Standard stock solution to a 200-mL volumetric flask.

Standard stock solution: 0.025 mg/mL of USP Triazolam RS in methanol

Dilute with water to volume.

Sample solution: Pass a portion of the solution under test through a suitable filter.

Mobile phase: Acetonitrile and water (40:60)

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 222 nm

Column: 4.6-mm x 10-cm

packing LZ

Flow rate: 1 mL/min

Injection volume: 200 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 500 theoretical plates

Relative standard deviation: NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of triazolam _{(USP 1-Aug-2023)} (C₁₇H₁₂CI₂N₄) dissolved:

Result = (r_u /r_s ) × C_s × V × (1/L) × 100

r_u = peak response of triazolam from the Sample solution

r_s = peak response of triazolam from the Standard solution

C_s = concentration of USP Triazolam RS in the Standard solution (mg/mL)

V = volume of Medium, 500 mL

L = label claim (mg/Tablet)

Tolerances: NLT 70% (Q) of the labeled amount of triazolam (C₁₇H₁₂CI₂N₄) is dissolved.

Change to read:

Uniformity of Dosage Units 〈905〉: Meet the requirements

_{(USP 1-Aug-2023)}

Add the following:

5 IMPURITIES

ORGANIC IMPURITIES

Solution A, Solution B, Mobile phase, Diluent, and Chromatographic system: Proceed as directed in the Assay.

Standard solution: 0.5 µg/mL of USP Triazolam RS in Diluent

Sensitivity solution: 0.05 µg/mL of USP Triazolam RS in Diluent

Sample solution: Nominally 50 µg/mL of triazolam from Tablets prepared as follows. Transfer an appropriate quantity of triazolam from finely powdered Tablets (NLT 20) to a suitable volumetric flask. Add 10% of the flask volume of water, mix by swirling, and allow to stand for 10 min. Vortex for 10 s, add 45% of flask volume of acetonitrile, shake using mechanical shaker for 10 min, dilute with water to volume, and mix well. Centrifuge a portion and use the clear supernatant.

System suitability

Samples: Standard solution and Sensitivity solution

Suitability requirements

Relative standard deviation: NMT 5.0%, Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of triazolam N-oxide and any unspecied degradation product in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × (1/F) × 100

r_u = peak response of each degradation product from the Sample solution

r_s = peak response of triazolam from the Standard solution

C_s = concentration of USP Triazolam RS in the Standard solution (µg/mL)

C_u = nominal concentration of triazolam in the Sample solution (µg/mL)

F = relative response factor (see Table 2)

Acceptance criteria: See Table 2. The reporting threshold is 0.1%.

Table 2

^a 8-Chloro-6-(2-chlorophenyl)-1-methyl-4H-s-triazolo[4,3-a][1,4]benzodiazepine 5-oxide.

_{(USP 1-Aug-2023)}

6 ADDITIONAL REQUIREMENTS

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PACKAGING AND STORAGE: Preserve in tight, light-resistant containers. Store at controlled room temperature

_{(USP 1-Aug-2023)}

USP REFERENCE STANDARDS (11)

USP Triazolam RS