Mannitol Analysis Service
Creative Proteomics offers specialized analytical services for a wide range of industries, focusing on precise quantification, purity testing, and stability studies of mannitol in pharmaceutical formulations, food products, and research applications. Using advanced technologies like HPLC with refractive index detection, we provide customized solutions tailored to meet the strictest regulatory standards and quality control requirements. Our expert team ensures accurate, reliable results, supporting product development, regulatory compliance, and quality assurance.
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What is Mannitol?
Mannitol, a naturally occurring sugar alcohol, is a versatile compound with a broad range of applications in various industries, particularly in pharmaceuticals, food products, and chemical manufacturing. Chemically known as D-mannitol, it is found in many plants, including fruits, vegetables, fungi, and certain seaweeds. The compound's name originates from the manna ash tree, from which it was first isolated in 1806.
Mannitol is widely valued for its unique physical and chemical properties. It has a mildly sweet taste and is commonly used as a sugar substitute in sugar-free and low-calorie foods. Its stability, low hygroscopicity, and non-toxic nature make it an excellent excipient in pharmaceutical formulations, such as intravenous solutions, tablets, and oral syrups. Moreover, mannitol is also used in specialized medical applications as a diuretic, particularly in the treatment of elevated intracranial pressure.
In addition to its widespread use in the food and pharmaceutical industries, mannitol's production and demand have grown in recent years, driven by advancements in manufacturing technologies. The various production methods, including extraction, fermentation, electrolysis, and high-temperature catalytic hydrogenation, have helped meet the increasing demand for mannitol across multiple sectors. Its diverse applications make it a critical component in both research and industrial settings.
Creative Proteomics offers highly specialized mannitol analysis services tailored to meet the stringent requirements of various industries, particularly the pharmaceutical and food sectors.
Mannitol Analysis Offered by Creative Proteomics
Quantification of Mannitol in Pharmaceutical Formulations
Accurate quantification of mannitol is essential for ensuring consistent dosage and regulatory compliance. Using HPLC with refractive index (RI) detection, we provide precise measurement of mannitol concentrations in pharmaceutical products.
Mannitol Purity and Related Substance Testing
We assess mannitol purity and identify impurities or degradation products using HPLC and related substance analysis, ensuring the quality and safety of pharmaceutical formulations, particularly for intravenous and oral dosage forms.
Stability Testing of Mannitol
Stability studies help determine the shelf-life of mannitol-based formulations. We conduct accelerated stability tests and long-term storage simulations to evaluate degradation rates in different environments and formulations.
Mannitol Detection in Food and Beverage Products
We offer precise detection and quantification of mannitol in food and beverages using HPLC and other analytical techniques, ensuring compliance with regulatory standards and labeling requirements.
Custom Analytical Services for Mannitol-Based Research
Our team provides customized analytical support for research on mannitol in pharmaceuticals or food applications, including molecular characterization and impurity profiling.
Technology Platforms for Mannitol Analysis
At Creative Proteomics, our primary method for analyzing mannitol in various formulations is High-Performance Liquid Chromatography (HPLC), which provides highly accurate, reproducible, and reliable data for quantification, purity testing, and impurity identification.
HPLC Instrumentation
For mannitol analysis, we utilize the Agilent 1260 Infinity HPLC System, a leading high-performance system known for its precision and reliability. Equipped with an advanced Refractive Index (RI) Detector, this HPLC system is ideal for detecting sugar alcohols like mannitol, which are often not UV-active. The Agilent 1260 Infinity offers exceptional sensitivity and resolution, making it the perfect tool for accurate mannitol quantification and purity testing in pharmaceutical and food products.
Column Specifications
We typically use the Rezex RCM-Monosaccharide Column for mannitol analysis. This column is specifically designed for the separation of sugar alcohols, offering excellent resolution and reliable results. Key specifications for the column include:
- Column Type: Rezex RCM-Monosaccharide
- Particle Size: 8 µm
- Dimensions: 300 x 7.8 mm I.D.
- Base Material: Organic polymer
- Functional Group: Sulfonic acid groups
- Counter Ion: Sodium (Na⁺)
Sample Requirements for Mannitol Analysis
| Sample Type | Required Sample Amount | Comments |
|---|---|---|
| Pharmaceutical Formulations | 1-2 g | For mannitol quantification, purity testing, and related substance analysis. |
| Intravenous Mannitol Solutions | 1-2 mL | For precise mannitol concentration measurement and impurity testing. |
| Oral Dosage Forms (Tablets, Syrups) | 1-2 tablets or 1-2 mL | To ensure proper mannitol content and assess stability. |
| Food and Beverage Products | 5-10 g | For accurate quantification of mannitol and compliance with labeling. |
| Raw Mannitol Samples | 1-2 g | For purity assessment and impurity profiling. |
| Research Samples (Custom Formulations) | 1-2 g or 1-2 mL | For tailored analysis based on specific formulation requirements. |
Applications of Mannitol Assay Service
- Pharmaceutical Formulations
Accurate quantification of mannitol in drug formulations, especially for intravenous solutions, tablets, and syrups, ensuring proper dosage and safety.
- Food and Beverage Industry
Precise detection and quantification of mannitol in sugar-free and low-calorie foods, ensuring compliance with regulatory standards and labeling requirements.
- Quality Control and Purity Testing
Thorough purity and related substance analysis of mannitol, ensuring the highest quality and safety standards in both pharmaceutical and food products.
- Research and Development
Customized analytical support for research into mannitol's role in new pharmaceutical or food formulations, including impurity profiling and molecular characterization.
Demo
Overlaid HPLC-CAD chromatograms of arabinose, fructose, mannitol, glucose, sucrose, and trehalose. (From Sławińska, Food Analytical Methods, 2021).
FAQ of Mannitol Analysis
Can your analysis detect impurities or degradation products in mannitol?
Yes, our HPLC method can identify and quantify impurities and degradation products in mannitol samples. This is crucial for ensuring the safety and quality of pharmaceutical formulations, especially for injectable or oral dosage forms. By using related substance analysis, we can detect trace levels of unwanted compounds, assess their concentration, and confirm whether they fall within acceptable limits.
What regulatory guidelines do you follow for mannitol analysis?
Our mannitol analysis methods are aligned with USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia) guidelines, ensuring compliance with industry standards for pharmaceutical and food products. We also adhere to FDA and EMA requirements for pharmaceutical testing to ensure the safety, quality, and efficacy of products. Our testing is conducted in accredited laboratories to meet international regulatory standards.
Can your analysis detect other sugar alcohols or related compounds in mannitol samples?
Yes, our HPLC method is capable of detecting and quantifying not only mannitol but also other sugar alcohols (such as sorbitol, xylitol, and erythritol) and related substances in samples. This is particularly useful in the food industry and pharmaceutical formulations, where mixtures of sugar alcohols are commonly used. Our analysis helps ensure that the intended levels of mannitol and related compounds meet regulatory requirements and quality standards.
Is mannitol analysis suitable for both large-scale production and small-batch testing?
Yes, our mannitol analysis services are suitable for both large-scale production and small-batch testing. Whether you are conducting routine quality control for large batches of pharmaceutical products or need small-batch testing for research and development purposes, our services are flexible and scalable to meet your needs. We ensure consistent and reliable results regardless of the sample size.
Learn about other Q&A.
Mannitol Analysis Case Study
Publications
Here are some publications in proteomics research from our clients:
- Enhance trial: effects of NAD3® on hallmarks of aging and clinical endpoints of health in middle aged adults: a subset analysis focused on blood cell NAD+ concentrations and lipid metabolism. 2022. https://doi.org/10.3390/physiologia2010002
- UDP-Glucose/P2Y14 Receptor Signaling Exacerbates Neuronal Apoptosis After Subarachnoid Hemorrhage in Rats. 2024. https://doi.org/10.1161/STROKEAHA.123.044422
- Inflammation primes the kidney for recovery by activating AZIN1 A-to-I editing. 2023. https://doi.org/10.1101/2023.11.09.566426
- Effects of Aronia melanocarpa juice-powder on hindgut function and performance in post-weaned pigs. 2024. https://doi.org/10.1016/j.jff.2024.106196
- Quantification of choline in serum and plasma using a clinical nuclear magnetic resonance analyzer. 2022. https://doi.org/10.1016/j.cca.2021.11.031
