Carboxymethylcellulose Calcium Analysis Service | Pharmaceutical Excipient

    Calcium carboxymethyl cellulose (CMC-Ca) is a water-soluble polymer compound formed by carboxymethylation of cellulose combined with calcium salt, and it is widely used as a pharmaceutical excipient. It has excellent water absorption, binding, and film-forming properties, making it suitable as a binder, disintegrant, and stabilizer in tablet formulations. CMC-Ca helps tablets disperse and release rapidly in the body while improving their mechanical strength and stability. As a safe and multifunctional excipient, CMC-Ca plays an important role in pharmaceutical development and quality control, contributing to enhanced bioavailability and clinical performance of drugs.

    1965352918757003264-carboxymethylcellulose-calcium-analysis-service-pharmaceutical-excipient1.PNG

    Hai, J. et al. Dalton Trans. 2019.

    Figure 1. Schematic Illustration of the Synthesis of CaCMC

    As a professional provider of pharmaceutical excipient analysis services, MtoZ Biolabs offers a comprehensive carboxymethylcellulose calcium analysis service that provides systematic evaluation of physical properties, chemical composition, functional performance, and safety to ensure that CMC-Ca meets international pharmacopeia standards and supports pharmaceutical R&D and manufacturing quality control. Our carboxymethylcellulose calcium analysis service covers key attributes including powder appearance, flowability, particle size, density, degree of substitution (DS), calcium content, pH value, solution viscosity, film-forming ability, dispersibility, heavy metals, microbial contamination, and moisture content, helping pharmaceutical companies obtain reliable excipient quality data.

     

    Services at MtoZ Biolabs

    MtoZ Biolabs’ carboxymethylcellulose calcium analysis service integrates advanced instruments and international standards to deliver systematic evaluation, including physical properties, chemical composition, functional performance, and safety assessment. The detailed analysis projects are summarized in the table below:

    Category

    Subcategory

    Purpose/Property

    Standard/Requirement

    Analytical Instruments/Methods

    Physical Properties

    Appearance and Powder Characteristics

    Powder color, flowability, hygroscopicity

    White or off-white, free-flowing, no unusual odor

    Visual inspection, microscope

    Particle Size Distribution

    Particle size and uniformity

    Meets formulation requirements

    Laser particle size analyzer, sieve, SEM

    Density and Packing

    True density, bulk density, tapped density

    Meets formulation requirements

    Density meter, graduated cylinder

    Chemical Composition

    Degree of Substitution (DS)

    Confirm level of carboxymethylation

    DS within pharmacopeia or client-specified range

    FTIR, NMR

    Calcium Content

    Ensure safety and performance

    Ca content within specified range

    AAS, ICP-OES

    pH Value

    Solution acidity / alkalinity

    5.0–8.0

    pH meter

    Functional Performance

    Viscosity

    Solution thickening ability

    Meets formulation viscosity requirements

    Viscometer

    Film-Forming Ability

    Ability to form uniform films

    Film uniform and free of cracks

    Visual inspection, microscope

    Dispersibility

    Uniformity in aqueous solution

    Fully dispersed without clumps

    Stirrer, visual inspection

    Safety and Impurity Analysis

    Heavy Metals

    Toxic element control

    Pb ≤ 20 ppm, Cd ≤ 1 ppm

    AAS, ICP-MS

    Microbial Contamination

    Compliance with pharmacopeia

    Free of pathogenic bacteria

    Incubator, plate count method

    Moisture Content

    Control water content

    ≤12%

    Oven, balance

     

    Analysis Workflow

    1. Sample reception and registration: Receive CMC-Ca powder samples and establish complete sample records.

    2. Sample preparation: Sub-sample, dry, or dissolve based on the analysis requirements.

    3. Physical property analysis: Measure appearance, powder flowability, particle size, and density.

    4. Chemical composition analysis: Determine DS, calcium content, and pH using FTIR, NMR, and AAS/ICP-OES.

    5. Functional performance testing: Evaluate solution viscosity, dispersibility, and film-forming properties.

    6. Safety and impurity analysis: Detect heavy metals, microbial contamination, and moisture content.

    7. Data processing and report generation: Organize data and produce a complete analytical report.

     

    Service Advantages

    1. Comprehensive Testing Coverage: MtoZ Biolabs’ carboxymethylcellulose calcium analysis service evaluates physical, chemical, functional, and safety properties, providing full-spectrum assessment from appearance and composition to performance, offering reliable data for formulation development and quality control.

    2. Strict Compliance with Pharmacopeia Standards: All testing methods reference international pharmacopeias, including USP and EP, ensuring results meet the quality control requirements of pharmaceutical excipients.

    3. Advanced Instrumentation Support: Utilizing FTIR, NMR, laser particle size analyzers, viscometers, AAS/ICP-OES, and other high-precision instruments ensures accurate, reliable data and enhances analytical credibility.

    4. Rapid Response and Flexible Service: Optimized workflows enable timely completion of routine and functional tests, while customized testing programs support diverse R&D and manufacturing needs.

    5. Safety and Compliance Assurance: Testing for heavy metals, microbial contamination, moisture content, and pH ensures that CMC-Ca meets pharmaceutical safety requirements, providing peace of mind for formulation development.

     

    Applications

    ✅Tablet and capsule formulation: As a thickening agent, film former, and stabilizer to enhance formulation performance.

    ✅Oral liquids and suspensions: Improve dispersibility and viscosity for uniform drug distribution.

    ✅Formulation process optimization: Evaluate CMC-Ca performance under various formulations and manufacturing conditions.

    ✅Pharmaceutical quality control: Raw material inspection and batch consistency evaluation.

     

    FAQs

    Q: How long does the carboxymethylcellulose calcium analysis service take?

    A: Routine analysis is typically completed within 7–10 working days, depending on the combination of tests.

     

    Sample Submission Suggestions

    1. Sample amount: 5–10 g of CMC-Ca powder per test is recommended.

    2. Packaging: Sealed, dry, and protected from moisture or contamination.

    3. Documentation: Provide batch number, manufacturer, production date, and any relevant safety data sheets (SDS).

    4. Shipping: Avoid high temperature and humidity; samples may be shipped via courier or under refrigerated conditions.

     

    Deliverables

    1. Analytical report including physical properties, chemical composition, functional performance, and safety assessment

    2. Data tables and raw instrument data (provided upon request)

    3. Recommendations and conclusions to support formulation development and quality control

     

    MtoZ Biolabs provides professional and comprehensive carboxymethylcellulose calcium analysis service, supporting excipient quality assurance and formulation development. Whether for excipient selection during R&D or quality control during production, we deliver reliable data support. 

    Contact us to submit your CMC-Ca samples and receive authoritative analytical reports ensuring safe, high-quality, and compliant pharmaceutical excipients.

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