Dextrate Analysis Service | Pharmaceutical Excipient

    Dextrate is a pharmaceutical excipient prepared from glucose units through partial hydrolysis of starch, commonly existing in the form of a white or off-white powder. It is essentially a polysaccharide derivative with both solubility and a certain degree of reducibility. The analytical principle mainly involves physicochemical testing methods, such as content determination, moisture detection, impurity control, and physicochemical parameter characterization, to systematically evaluate the composition, purity, and quality characteristics of the sample, thereby ensuring its safety and reliability in pharmaceutical use. With good solubility and stability, it is widely applied in excipient compatibility and performance evaluation during drug formulation development and quality control.

     

    Services at MtoZ Biolabs

    Based on advanced technology and analytical platforms, MtoZ Biolabs has launched the dextrate analysis service based on pharmaceutical excipient which can comprehensively evaluate the physical properties, content, and key chemical indicators of excipients. This service can fully reveal the structural and quality characteristics of samples, providing reliable data support for drug development, formulation design, and production quality control. MtoZ Biolabs provides services including but not limited to the following:

     

    1. Physical Properties

    Evaluate the adaptability and operability of samples in different formulation environments through appearance characterization and solubility testing.

     

    2. Content Determination

    Accurately measure the level of the main component to ensure consistency and stability of excipients across different batches.

     

    3. pH Measurement

    Detect the acidity and alkalinity of the solution to reflect the environmental adaptability of samples in application processes.

     

    4. Heavy Metal Detection

    Monitor the presence and levels of harmful elements to ensure the safety of excipients during use.

     

    5. Moisture Determination

    Analyze the effect of water content on storage and processing stability, avoiding quality issues caused by excessive or insufficient levels.

     

    6. Impurity Detection

    Identify and quantify potential impurities to ensure the purity of excipients and meet the quality standards required for drug development and production.

     

    Sample Submission Suggestions

    1. Sample Type

    Applicable to Dextrate samples in powder or solid form. Samples should be uniform and representative to ensure the reliability of test results.

     

    2. Sample Purity

    It is recommended to remove impurities and moisture to avoid interference from external components with the accurate detection of physicochemical parameters (such as content, pH, and impurity levels).

     

    3. Sample Storage

    Samples should be stored in a dry, dark, and appropriate temperature environment to prevent moisture absorption or oxidation that may cause changes in physicochemical properties.

     

    4. Sample Transportation

    During transportation, sealed containers should be used. If necessary, combine with moisture-proof packaging or cold-chain conditions to ensure the sample remains stable and intact before reaching the testing platform.

     

    Service Advantages

    1. Comprehensive Testing

    Combining multidimensional physicochemical analyses, it can systematically evaluate the key quality indicators of Dextrate, ensuring scientifically reliable results.

     

    2. High Precision and Sensitivity

    By strictly controlling experimental conditions, it achieves accurate determination of content, pH, moisture, and impurities.

     

    3. Professional Technical Team

    Data analysis and quality evaluation are conducted by experienced experts, ensuring authoritative and credible results.

     

    4. Efficient Service Process

    MtoZ Biolabs provides both standardized and customized testing solutions, shortening cycles and supporting research and quality control.

     

    Applications

    1. Formulation Development

    Dextrate analysis service can be used to evaluate its suitability in different pharmaceutical formulations, supporting excipient application research in tablets, granules, and other dosage forms.

     

    2. Solubility and Stability Studies

    By testing the solubility and physicochemical properties of Dextrate, it helps optimize the solubility of poorly soluble drugs and the stability of formulations.

     

    3. Drug Delivery Systems

    Dextrate analysis service can be used to assess its role as a drug carrier or excipient in oral formulations and other delivery systems, supporting studies on drug release and bioavailability.

     

    4. Biomaterials Research

    It is suitable for analyzing the compatibility and functional performance of Dextrate in bio-related materials, providing references for the development of new excipients and materials.

     

    FAQ

    Q1: Can Dextrate Be Directly Detected by Ultraviolet Absorption Method?

    A1: It is not suitable. The structure of Dextrate lacks obvious ultraviolet absorption groups, and conventional UV methods cannot accurately characterize its content and properties. More appropriate analytical methods are required.

     

    Q2: Compared with Other Excipients, What Are the Particularities of Detecting Dextrate?

    A2: As a polysaccharide substance, Dextrate is more sensitive in solubility and impurity testing. The focus of detection is more on content uniformity, moisture control, and impurity levels.

     

    Q3: What Are the Limitations of This Analytical Method?

    A3: For samples with non-uniform surfaces or high impurity levels, results may show deviations. In addition, the detection sensitivity for certain trace components is limited, and other techniques are needed for supplementary verification.

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