Atropine Sulfate 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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Atropine Sulfate Injection

1 DEFINITION

Atropine Sulfate Injection is a sterile solution of Atropine Sulfate in Water for Injection. It contains NLT 93.0% and NMT 107.0% of the labeled amount of atropine sulfate monohydrate (C₁₇H₂₃NO₃)₂·H₂SO₄·H₂O

2 IDENTIFICATION

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

3 ASSAY

Change to read:

Procedure

Buffer: Dissolve 4.1 g of anhydrous sodium acetate and 2.9 mL of glacial acetic acid in 1 L of water.

Mobile phase: Transfer 5.1 g of tetrabutylammonium hydrogen sulfate to a 1-L volumetric flask. Add 50 mL of acetonitrile, and dilute with Buffer to volume. Adjust with 5 N sodium hydroxide to a pH of 5.5.

System suitability solution: 0.5 µg/mL of p-hydroxybenzoic acid and 64 µg/mL of USP Atropine Sulfate RS in water

Standard solution: 80 µg/mL of USP Atropine Sulfate RS

Sample solution: Nominally equivalent to 80 µg/mL of atropine sulfate in water, from a volume of the Injection containing an amount equivalent to 2 mg of atropine sulfate

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 30-cm × 3.9-mm; packing L1

Flow rate: 2 mL/min

Injection volume: 100 µL

System suitability

Samples: System suitability solution and Standard solution

[Note—The relative retention times of atropine and p-hydroxybenzoic acid are 1.0 and 1.6, respectively.]

Suitability requirements:

Resolution: NLT 2.2 between p-hydroxybenzoic acid and atropine, System suitability solution

Relative standard deviation: NMT 1.5%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of atropine sulfate monohydrate (C₁₇H₂₃NO₃)₂·H₂SO₄·H₂O  in the portion of the Injection taken:

Result = (r_U / r_S) × (C_S / C_U) × (M₁ / M₂) × 100

r_U = peak response from the Sample solution

r_S= peak response from the Standard solution

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

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

M₁ = molecular weight of atropine sulfate monohydrate, 694.84

M₂ = molecular weight of anhydrous atropine sulfate, 676.82

Acceptance criteria: 93.0%–107.0%

Atropine-Sulfate-Injection-ttt

4 SPECIFIC TESTS

pH 〈791〉: 3.0–6.5

Bacterial Endotoxins Test 〈85〉: NMT 55.6 USP Endotoxin Units/mg of atropine sulfate

Other Requirements: Meets the requirements in Injections and Implanted Drug Products 〈1〉

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Store at controlled room temperature.

USP Reference Standards 〈11〉: USP Atropine Sulfate RS