Hypromellose Analysis Service | Pharmaceutical Excipient
Hypromellose is a nonionic cellulose ether derivative widely used in the pharmaceutical industry. It is derived from natural cellulose through methylation and hydroxypropylation, and is characterized by excellent solubility, film-forming ability, and stability. In pharmaceutical formulations, hypromellose is commonly employed as a tablet binder, disintegrant, sustained-release matrix material, and capsule shell component. It plays a critical role in controlling drug dissolution rate, stability, and bioavailability. Therefore, systematic analysis of hypromellose quality and physicochemical properties is essential to ensure the safety and consistency of pharmaceutical products.
Mašková, E. et al. J Control Release. 2020.
As a professional multi-omics and excipient analysis service provider, MtoZ Biolabs delivers a hypromellose analysis service that supports pharmaceutical companies, research institutions, and quality control departments in evaluating excipient characteristics, meeting pharmacopeial requirements, and obtaining reliable data for drug development.
Services at MtoZ Biolabs
MtoZ Biolabs’ hypromellose analysis service is based on a multidimensional testing strategy, covering structural characterization, purity assessment, substitution degree analysis, and performance evaluation. We integrate chromatography, spectroscopy, viscosity measurement, and molecular weight characterization to guarantee accurate and reliable results. Key analysis items include:
1. Physicochemical property testing: Appearance, moisture, ash content, pH value, solubility, and other basic indicators to ensure compliance with pharmacopeial standards.
2. Substitution degree and molecular structure analysis: Determination of methyl and hydroxypropyl substitution patterns to assess structural uniformity.
3. Molecular weight and viscosity testing: Gel permeation chromatography (GPC) and viscometry to evaluate polymerization degree distribution and rheological behavior.
4. Impurity and residual solvent analysis: Detection of organic/inorganic impurities and residual solvents that may impact safety.
5. Stability and degradation studies: Evaluation of hypromellose stability under different conditions and identification of degradation products and potential risks.
Our hypromellose analysis service not only covers standardized testing needs but also offers customized solutions tailored to specific research and development projects, supporting novel formulation development and quality consistency studies.
Analysis Workflow
1. Sample receipt and pretreatment: Homogenization, drying, or dissolution depending on sample type.
2. Preliminary physicochemical screening: Measurement of basic properties such as moisture, ash, and pH.
3. Structural and performance analysis: Application of spectroscopy, chromatography, and viscometry for molecular and functional evaluation.
4. Data integration and validation: Cross-validation of results from multiple platforms to ensure accuracy and reproducibility.
5. Report generation and delivery: Provision of complete test results with essential technical interpretation.
Service Advantages
1. Integrated Multi-Platform Analysis
MtoZ Biolabs combines spectroscopy, chromatography, and viscosity testing to provide a comprehensive hypromellose analysis service from molecular structure to physical performance. Cross-validation ensures reliable results and minimizes bias from single-method limitations.
2. Regulatory and Pharmacopeial Compliance
Our methods strictly adhere to major pharmacopeias such as USP and EP, ensuring results that meet regulatory submission and quality evaluation requirements, reducing the risk of redundant testing.
3. Customized Analytical Solutions
We design flexible testing schemes tailored to different dosage forms and research needs, providing multi-tiered services from basic QC testing to advanced studies, supporting both routine control and innovative formulation development.
4. Experienced Professional Team
Our experts possess pharmaceutical and analytical chemistry backgrounds and are familiar with the characteristics and potential challenges of hypromellose.
5. Efficient Report Delivery
We emphasize both accuracy and timeliness. Reports include clear experimental methods, spectra, chromatograms, viscosity curves, data tables, and conclusions, allowing clients to quickly understand and apply results in R&D and submissions.
Applications
✔️ Pharmaceutical formulation development: Evaluation of hypromellose performance in tablets, capsules, and sustained-release formulations.
✔️ Quality consistency research: Provision of excipient characterization data for generic drug development and bioequivalence studies.
✔️ Drug registration and submission: Compliance with regulatory requirements for excipient quality assessment.
✔️ Scientific research: Structural and property characterization of novel cellulose derivatives.
FAQs
Q1: Why is substitution degree analysis of hypromellose important?
A1: The degree of substitution directly affects solubility, viscosity, and film-forming properties, making it a key parameter for evaluating excipient performance and formulation stability.
Sample Submission Suggestions
1. Sample type: Hypromellose in powder, granule, or solution form.
2. Sample quantity: Recommended ≥5 g; smaller amounts accepted in special cases.
3. Storage and transport: Store sealed to prevent moisture or contamination; transport at ambient temperature is recommended.
4. Additional information: Provide product source, batch number, and intended analysis items to facilitate optimal testing design.
Deliverables
1. Comprehensive experimental report: Including experimental design, methods, and conditions.
2. Data results: Spectra, chromatograms, viscosity curves, and numerical tables.
3. Quality control and method validation details: Demonstrating reproducibility and reliability.
4. Technical conclusions: Summarizing hypromellose quality characteristics and its suitability for formulation use.
As a commonly used pharmaceutical excipient, hypromellose directly affects the quality and efficacy of drug formulations, and its comprehensive analysis is a critical step in drug development as well as a requirement for pharmacopeial compliance and clinical safety, which is why MtoZ Biolabs offers the hypromellose analysis service supported by advanced analytical platforms and professional technical expertise. If you are seeking a trusted partner for excipient analysis, we welcome you to collaborate with us and advance your R&D and registration processes together.
How to order?
