Introduction

Mannitol is a six-carbon sugar alcohol with important applications in pharmaceutical and food industries.

In pharmaceutical industry, it is used as a hyperosmotic diuretic. It increases plasma osmotic pressure upon intravenous administration, promoting the transfer of interstitial fluid into the vascular system. This reduces tissue edema and lowers intracranial pressure, demonstrating remarkable efficacy for conditions such as cerebral edema and renal edema while also preventing acute renal failure. Its diuretic effect aids in eliminating excess water and electrolytes from the body. However, strict control of dosage and infusion rate is essential to avoid adverse reactions like electrolyte imbalance and osmotic nephropathy.

In food industry, it serves as a sweetener and humectant, widely used in the production of candies, chewing gum, baked goods, and other food products. It possesses moisture-retaining properties and prevents crystallization.

National Standards for Mannitol Determination

Due to the importance of mannitol in these industries, its determination is monographed in major pharmacopoeias worldwide, notably USP-NF 2025, EP 11, JP 18, and ChP 2025.

For example, in Chinese Pharmacopoeia 2025 Edition, the related substance section specifies that the retention times of isomalt peak 1, maltitol, isomalt peak 2, and sorbitol relative to mannitol should be 0.60, 0.69, 0.73, and 1.2, respectively; the resolution between mannitol and sorbitol peaks should be greater than 2.0 in system suitability solution I, and the resolution between maltitol and isomalt peak 1 should satisfy in system suitability solution II. Sample preparation protocols in this edition are also modified to better align with other pharmacopoeias mentioned above, enhancing the accuracy of the standard.