Powdered Cellulose Analysis Service | Pharmaceutical Excipient
Powdered cellulose is a widely used pharmaceutical excipient. Essentially purified and refined cellulose, it appears as a white or nearly white amorphous powder with non-toxic, tasteless, and non-irritating properties. In pharmaceutical formulations, powdered cellulose is commonly used as a filler, diluent, or suspending agent, improving both the processing performance and stability of drugs. It has broad applications in tablets, capsules, oral suspensions, suppositories, and other dosage forms, making it an indispensable raw material for ensuring the quality and safety of drug formulations.
With the continuous advancement of drug development, stricter requirements have been placed on the quality standards of excipients. Powdered cellulose must not only meet pharmacopeial specifications in terms of its physical properties and chemical composition but must also undergo systematic testing to verify its stability, purity, and applicability. Leveraging a comprehensive analytical platform and a professional technical team, MtoZ Biolabs offers powdered cellulose analysis service that delivers reliable, end-to-end excipient testing and evaluation solutions to research institutions, pharmaceutical companies, and quality control departments.
Services at MtoZ Biolabs
The powdered cellulose analysis service goes beyond the measurement of basic physicochemical properties and also includes assessments of purity, stability, particle size distribution, and microbiological safety. MtoZ Biolabs, combining pharmacopeial standards with advanced analytical techniques, provides systematic testing and comprehensive quality evaluation.
| Service Category | Analytical Items | Description |
| Basic Identification | Appearance, chemical reactions, infrared spectroscopy (IR), nuclear magnetic resonance (NMR), mass spectrometry (MS) | Multilevel techniques confirm the structural features and authenticity of powdered cellulose |
| Physicochemical Properties | pH measurement, solubility testing, viscosity testing | Evaluate stability and applicability under different conditions |
| Impurity and Purity Analysis | Residue on ignition, HPLC, GC | Detect inorganic impurities, volatile components, and organic contaminants to ensure purity |
| Elemental and Safety Testing | Heavy metals (ICP-MS/AAS) | Determine whether harmful elemental content meets safety thresholds |
| Particle Size and Morphology | Laser diffraction, microscopic observation | Assess particle size distribution and powder uniformity |
| Microbiological Testing | Microbial limits, yeast and mold count | Ensure hygienic and microbiological safety |
| Stability Studies | Storage under heat, humidity, and light | Evaluate the impact of environmental conditions on powdered cellulose properties |
Analysis Workflow
1. Sample Receipt and Pretreatment: Samples undergo appearance checks, weighing, and necessary pretreatment.
2. Basic Physicochemical Tests: Assessment of appearance, pH, viscosity, and solubility.
3. Instrumental Analysis: Advanced techniques including IR, HPLC, GC, and ICP-MS are applied for in-depth analysis.
4. Microbiological and Stability Tests: Verification of safety and consistency under variable conditions.
5. Data Integration and Report Generation: Comprehensive report compiling all findings with clear scientific conclusions.
Service Advantages
1. Comprehensive Testing Dimensions
MtoZ Biolabs provides coverage across appearance, physicochemical properties, purity, safety, and stability, delivering a systematic quality profile of powdered cellulose.
2. Compliance with Pharmacopeial Standards
Our powdered cellulose analysis service follows USP, EP, and other international pharmacopeias, ensuring compliance and facilitating regulatory submissions across global markets.
3. Multi-Platform Analytical Integration
By combining spectroscopy, chromatography, and mass spectrometry, our approach provides higher accuracy and reliability, minimizing limitations of single-method analyses.
4. Flexible and Customized Options
Clients may choose full-package analysis or targeted testing. Tailored packages support early R&D and regulatory submission stages, saving both time and resources.
5. One-Time Charge
Our pricing is transparent, with no hidden fees or additional costs.
Applications
1. Drug Development: Evaluate excipient applicability and compatibility, supporting formulation design.
2. Quality Control: Ensure excipient consistency and safety in production.
3. Regulatory Submission: Generate excipient quality data for drug registration and review.
4. Formulation Stability Studies: Assess excipient performance under different storage environments.
FAQs
Q1: What is the difference between powdered cellulose and microcrystalline cellulose?
A1: Both originate from cellulose. Microcrystalline cellulose is highly crystalline, whereas powdered cellulose is relatively amorphous, making it suitable as a filler or suspending agent.
Sample Submission Suggestions
1. Sample Type: Powdered solid, free from visible clumps or contamination.
2. Sample Quantity: ≥20 g recommended to ensure smooth analysis across all parameters.
3. Storage Conditions: Store sealed and protected from light, avoid moisture exposure.
4. Transportation Conditions: Sealed at ambient temperature; low-temperature transport available upon request for special studies.
Deliverables
1. Complete experimental data and raw spectra (e.g., IR spectra, HPLC chromatograms, particle size distribution curves)
2. Summarized results tables and indicator evaluations
3. Comparative analysis and compliance statement
4. Professional conclusive report (PDF format)
5. Optional English report to support international submissions
As a commonly used excipient in pharmaceutical formulations, the quality control of powdered cellulose directly affects drug safety and stability. With advanced analytical platforms and extensive expertise, MtoZ Biolabs delivers comprehensive and reliable powdered cellulose analysis service to help pharmaceutical companies accelerate development and meet regulatory requirements.
Contact us today to obtain a tailored analysis solution and advance high-quality drug research and applications.
How to order?
