Pregelatinized Starch Analysis Service | Pharmaceutical Excipient

Pregelatinized starch is a type of modified starch produced through physical or chemical processing that disrupts part or all of the starch granules. It is characterized by excellent flowability and direct compressibility, making it widely applied in the development of tablets and capsules. As a pharmaceutical excipient, pregelatinized starch functions as a diluent, disintegrant, and binder, while also improving tablet hardness, dissolution rate, and stability. Pharmacopeias such as the USP and Ph. Eur. provide specifications and quality standards, underscoring the importance of this excipient in drug formulation.

 

Figure 1. The Structure of Pregelatinized Starch

 

In the pharmaceutical industry, the quality of excipients directly impacts drug safety and efficacy. With the continuous tightening of global formulation development and regulatory requirements, the physicochemical properties, functional performance, and impurity control of pregelatinized starch have become critical concerns for pharmaceutical companies and research institutions.

 

As a professional pharmaceutical excipient analysis CRO, MtoZ Biolabs offers systematic pregelatinized starch analysis service based on advanced analytical platforms and an experienced technical team, delivering reliable data support for drug R&D, quality control, and regulatory submission.

 

Services at MtoZ Biolabs

The analysis of pregelatinized starch involves not only basic physicochemical testing but also a comprehensive evaluation of functional performance and impurity levels. MtoZ Biolabs, following pharmacopeial standards and industry guidelines, provide a pregelatinized starch analysis service covering the following aspects:

1. Physicochemical Property Analysis: Including appearance, color, particle size distribution, density (bulk, tapped, true), moisture content, pH, and viscosity.

2. Functional Performance Evaluation: Testing flowability, compressibility, disintegration time, and tablet hardness to assess excipient performance in formulations.

3. Impurity and Safety Testing: Covering heavy metals, sulfate ash, oxidizing substances, microbial limits, and residual solvents to ensure safety in pharmaceutical use.

4. Stability Studies: Monitoring changes in physicochemical and functional properties under varying temperature and humidity conditions to evaluate storage stability.

5. Customized Testing: Flexible adjustment of test items and scope based on R\&D objectives or registration requirements, with compliance-ready reports.

 

MtoZ Biolabs conducts pregelatinized starch analysis service using multi-platform testing, including HPLC, FTIR, GC-MS, ICP-MS, XRD, and microscopy, ensuring accuracy and reliability of results.

 

Analysis Workflow

1. Sample Reception and Verification: Registration and preliminary inspection of submitted samples.

2. Physicochemical and Functional Testing: Execution of standard tests for physical, chemical, and application-related performance.

3. Impurity and Safety Testing: Detection of heavy metals, microbial load, and potential harmful residues.

4. Data Review and Interpretation: Statistical analysis and comparison against pharmacopeial standards.

5. Report Delivery: Comprehensive test results with professional interpretation and recommendations when applicable.

 

Service Advantages

1. Comprehensive Analytical Capability

MtoZ Biolabs offers a complete testing framework covering physicochemical properties, functional performance, impurity detection, and stability studies. This multi-dimensional approach provides clients with an in-depth understanding of excipient quality across development, production, and registration.

 

2. Standard-Driven Methodology

All testing procedures follow international pharmacopeias (USP, Ph. Eur.) and widely accepted industry standards, ensuring scientific rigor and comparability. This alignment supports both research applications and regulatory submissions.

 

3. Flexible and Customized Solutions

We design testing packages that adapt to different development stages. Early R\&D may focus on functional evaluation, while later registration emphasizes impurity and compliance testing, ensuring efficient use of resources.

 

4. Experienced Technical Team

Our team brings extensive expertise in excipient testing, providing not only accurate data but also professional interpretation in the context of real-world applications, supporting informed decision-making.

 

5. Efficient and Reliable Project Management

Through standardized internal workflows and strict quality control, we ensure projects are completed within reasonable timelines while delivering complete and compliant reports, saving clients both development time and communication costs.

 

Applications

✔️ Drug Development: Evaluate functional performance of pregelatinized starch in tablets and capsules and screen suitable excipients.

✔️ Quality Control: Routine batch testing to ensure excipient quality consistency.

✔️ Regulatory Submission: Provide compliance-ready data for new drug applications and regulatory review.

✔️ Process Optimization: Verify excipient adaptability during formulation process improvements or optimization.

✔️ Basic Research: Explore functional properties in food, material, and related research fields.

FAQs

Q1: What is the difference between pregelatinized starch and native starch?

A1: Pregelatinized starch undergoes modification that disrupts starch granules, resulting in improved flowability and compressibility, making it suitable for direct compression. Native starch is primarily used in traditional wet granulation.

 

Q2: What is the usual turnaround time for the pregelatinized starch analysis service?

A2: Standard testing requires approximately 2–3 weeks. Projects involving stability or special studies may take longer.

 

Sample Submission Suggestions

1. Samples should be well-sealed to avoid moisture uptake or contamination.

2. Powder form samples of at least 50 g are recommended.

3. For samples with special origins (e.g., starch from different botanical sources), please provide details upon submission.

4. Normal temperature shipping is acceptable, though moisture-proof packaging is advised during humid seasons.

5. Clients are encouraged to consult our technical support team before submission for detailed guidance.

 

Deliverables

1. Sample reception and inspection records

2. Complete test data (physicochemical properties, functional performance, impurity levels, stability, etc.)

3. Comparative analysis against pharmacopeial or regulatory standards

4. Professional data interpretation and summary

5. Comprehensive test report (electronic and/or hard copy upon request)

 

With the rising standards for excipient quality in the pharmaceutical industry, systematic testing of pregelatinized starch is essential for ensuring drug safety and efficacy. MtoZ Biolabs, equipped with multi-platform testing capabilities and an experienced team, delivers high-quality pregelatinized starch analysis service to support your R&D and registration efforts.

 

Contact MtoZ Biolabs today to obtain tailored testing solutions and drive your projects forward efficiently and reliably.