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.
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.
How to order?
