Steviol Glycoside Analysis Service | Pharmaceutical Excipient

Steviol glycosides are a class of natural diterpene glycosides extracted from Stevia rebaudiana. With their strong sweetness and excellent safety profile, they are widely used in food, health products, and pharmaceutical formulations. In pharmaceutical research and production, steviol glycosides as pharmaceutical excipients not only improve the taste of drugs and enhance patient compliance but also play roles in controlled release, film formation, and stabilization. As global pharmaceutical regulatory standards continue to rise, the source, purity, impurity control, and stability testing of steviol glycosides have become critical components of the pharmaceutical quality system.

 

 

Figure 1. The Structure of Steviol Glycoside

 

MtoZ Biolabs, as a professional pharmaceutical excipient analysis CRO, relies on advanced analytical platforms and an experienced team to provide Steviol Glycoside Analysis Service that delivers systematic and reliable analysis and evaluation for pharmaceutical companies and research institutions, supporting product development and regulatory submission.

 

Services at MtoZ Biolabs

MtoZ Biolabs’ steviol glycoside analysis service covers chemical composition, physicochemical properties, safety, and functional evaluation to ensure excipients meet quality standards and regulatory requirements in drug development and application. To achieve this, we provide a range of targeted assessments, including:

✔️ Composition and Purity Testing: Qualitative and quantitative analysis of different types of steviol glycosides (e.g., Stevioside, Rebaudioside series), assessing the proportion of main components and total content.

✔️ Impurity and Residue Assessment: Testing for heavy metals, pesticide residues, solvent residues, and other potential impurities to ensure safety.

✔️ Physicochemical Characterization: Including appearance, solubility, optical rotation, stability, and thermal properties to evaluate suitability in various formulations.

✔️ Stability Studies: Simulated experiments under temperature, humidity, and light conditions to assess degradation trends and storage requirements.

✔️ Functional Evaluation: Analysis of the role of steviol glycosides in improving taste, assisting controlled release, and enhancing stabilization in pharmaceutical formulations.

 

Analysis Workflow

1. Sample Receipt and Registration: Assigning identifiers and confirming sample information.

2. Sample Preparation: Dissolving, extracting, or purifying samples as required.

3. Composition and Impurity Analysis: Using chromatographic and spectroscopic techniques to assess composition, purity, and impurities.

4. Physicochemical and Stability Testing: Conducting tests under standard and accelerated conditions.

5. Data Integration and Review: Comprehensive data analysis and quality control.

6. Report Delivery: Providing a systematic report including data, conclusions, and recommendations.

 

Service Advantages

1. Comprehensive Analysis Coverage

MtoZ Biolabs offers complete steviol glycoside analysis service, including composition, purity, physicochemical properties, impurities, and stability. This meets the diverse needs of pharmaceutical R&D, quality control, and regulatory submission, helping clients gain a systematic understanding of steviol glycoside properties.

 

2. International Standard Compliance

Our analytical workflows follow multiple international pharmacopeias and guidelines, ensuring globally comparable and widely accepted results, especially for formulations aimed at overseas markets.

 

3. Advanced Platforms and Multi-Technology Integration

MtoZ Biolabs leverages chromatographic, mass spectrometric, and spectroscopic platforms, together with an experienced team, to guarantee accurate and reliable analysis of steviol glycosides from different sources and grades.

 

4. Customized Solutions

We provide flexible testing packages and tailored steviol glycoside analysis services designed to meet specific project goals and development stages, supporting early-stage screening, process optimization, and regulatory submission.

 

5. Efficient Project Management and Report Delivery

With robust internal processes and professional technical support, MtoZ Biolabs ensures timely project execution and delivers comprehensive reports with clear conclusions, helping clients accelerate R&D and regulatory progress.

 

Applications

1️⃣ Oral Formulations: Improving palatability in tablets, capsules, and oral liquids to enhance patient compliance.

2️⃣ Controlled and Sustained Release Systems: Adjusting drug release profiles and improving formulation stability.

3️⃣ Combination Formulations: Enhancing overall performance as part of excipient systems.

4️⃣ Quality Control and Regulatory Submission: Providing compliance data for excipient evaluation.

5️⃣ Functional Foods and Health Products: Improving taste and safety in non-pharmaceutical products.

 

Sample Submission Suggestions

1. Samples should be kept dry, avoiding moisture and contamination.

2. Recommended amount: at least 5 g; for solutions, concentration and solvent must be specified.

3. Provide a basic sample information sheet including source, batch number, and intended application.

4. Special storage or transportation conditions should be communicated with technical support in advance.

 

Deliverables

1. Detailed Analytical Report: Covering methods, test data, charts, and conclusions.

2. Quality Assessment Conclusion: Evaluating sample compliance with standards.

3. Raw Data Files: Partial raw data provided upon request.

4. Improvement and Application Suggestions: Offering reference recommendations for formulation development and excipient selection.

 

As a natural pharmaceutical excipient, the quality and safety of steviol glycosides directly affect the stability of formulations and patient experience. Leveraging advanced analytical platforms and a professional team, MtoZ Biolabs provides systematic steviol glycoside analysis service to support research and industry clients in achieving compliance and product optimization in R&D, regulatory submission, and production.

 

Contact our technical support team for more information and customized solutions, and work with us to advance the scientific application and innovative development of pharmaceutical excipients.