Sumatriptan Injection

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

Sumatriptan Injection is a sterile solution of Sumatriptan Succinate in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of sumatriptan (C₁₄H₂₁N₃O₂S).

2 IDENTIFICATION

A. The retention time of the major peak in the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

PROCEDURE

Buffer: Add 1.7 mL of butylamine, 0.66 mL of phosphoric acid, and 3.7 g of monobasic sodium phosphate to 900 mL of water. Mix, and adjust with 1 N sodium hydroxide to a pH of 7.5 ± 0.1. Dilute with water to 1000 mL.

Mobile phase: Acetonitrile and Buffer (17:83) Diluent: Acetonitrile and water (50:50)

Standard solution: 0.14 mg/mL of USP Sumatriptan Succinate RS in Diluent Sample solution: Nominally 0.1 mg/mL of sumatriptan from the Injection in Diluent Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 227 nm

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

Flow rate: 1.5 mL/min

Injection size: 10 µL

Run time: About 3 times the retention time of sumatriptan

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0% Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of sumatriptan (C₁₄H₂₁N₃O₂S) in the portion of Injection taken:

Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

M_r1 = molecular weight of sumatriptan free base, 295.40

M_r2 = molecular weight of sumatriptan succinate, 413.49

Acceptance criteria: 90.0%–110.0%

4 SPECIFIC TESTS

PH 〈791〉: 4.2–5.3

OSMOLALITY AND OSMOLARITY 〈785〉: 270–330 mOsmol/kg

PARTICULATE MATTER IN INJECTIONS 〈788〉: Meets requirements

BACTERIAL ENDOTOXINS TEST 〈85〉: It contains NMT 29.2 USP Endotoxin Units/mg of sumatriptan.

STERILITY TESTS 〈71〉: Meets the requirements

OTHER REQUIREMENTS: It meets the requirements under Labeling 〈7〉, Labels and Labeling for Injectable Products.

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in single-dose containers, preferably of Type 1 glass. Store between 2° and 30°, protected from light.

USP REFERENCE STANDARDS 〈11〉

USP Sumatriptan Succinate RS