Pharmaceutical Impurity Analysis Service
Pharmaceutical impurity analysis is a critical component of drug development and quality assurance. Impurities are any unwanted chemicals that remain with an active pharmaceutical ingredient (API) or develop during formulation, packaging, or storage. They may arise from raw materials, synthetic processes, degradation pathways, or contamination during manufacturing. Many regulatory agencies classify impurities as critical quality attributes because their presence directly impacts drug safety, efficacy, and stability.
Pharmaceutical Impurity Analysis Service involves the identification, quantification, and characterization of impurities in drug substances and drug products. These include organic impurities, inorganic impurities, residual solvents, elemental impurities, genotoxic impurities, and degradation products. Accurate impurity profiling ensures compliance with related pharmacopeial guidelines, helping pharmaceutical companies minimize risks, avoid costly recalls, and safeguard patient safety.
Service at MtoZ Biolabs
MtoZ Biolabs offers comprehensive Pharmaceutical Impurity Analysis Service to support all stages of drug research, development, and manufacturing. Our laboratory platform integrates advanced chromatography, high-resolution mass spectrometry, and regulatory-compliant workflows to deliver accurate and reproducible impurity profiling.
Our Pharmaceutical Impurity Analysis Services include:
💠Organic Impurity Profiling
Detection and quantification of process-related impurities, intermediates, and degradation products. Organic impurities may originate from incomplete reactions, side reactions, or degradation of active pharmaceutical ingredients during synthesis or storage.
💠Residual Solvent Analysis
Evaluation of volatile organic solvents using headspace GC-MS. Residual solvents can remain in the drug substance or product as by-products of the synthesis process, crystallization steps, or purification procedures, and must be controlled to ensure patient safety.
💠Elemental Impurity Testing
Quantification of heavy metals and other trace elements using ICP-MS. Elemental impurities may be introduced through catalysts, raw materials, manufacturing equipment, or container closure systems, and can pose significant toxicological risks if not properly monitored.
💠Genotoxic Impurity Analysis
Sensitive detection and risk assessment of potentially mutagenic impurities that could adversely affect long-term patient safety.
💠Degradation Product Studies
Forced degradation testing and identification of breakdown products under thermal, photolytic, and oxidative stress conditions, helping predict drug stability and shelf life.
💠Stability-Indicating Methods
Development of validated methods to monitor impurities over the duration of the drug's lifecycle, ensuring consistency and safety of pharmaceutical products.
Analysis Workflow
1. Sample Submission and Verification
Collection and assessment of drug substances, excipients, or formulations.
2. Method Development and Validation
Designing impurity analysis methods specific to the product type and regulatory guidelines.
3. Chromatographic Separation
Using HPLC, UPLC, or GC to separate impurities from the main API.
4. Detection and Identification
Employing LC-MS, GC-MS, or spectroscopic techniques to identify impurity structures.
5. Quantification
Accurate measurement of impurity levels against pharmacopeial limits.
6. Stability and Degradation Studies
Stress testing to reveal potential degradation pathways and products.
7. Data Interpretation and Reporting
Detailed reporting of results, including regulatory compliance assessment.
Service Advantages
✔️Cutting-Edge Analytical Platforms
We utilize advanced TLC, HPLC, LC-MS, GC-MS, ICP-MS, DTA, and TGA systems that provide high sensitivity, broad coverage, and precise impurity characterization.
✔️Comprehensive Testing Capability
From organic impurities and residual solvents to elemental impurities, degradation products, and genotoxic compounds, we offer complete impurity profiling.
✔️Expert Team of Scientists
Our analytical chemists and quality specialists bring extensive experience in pharmaceutical impurity testing, method development, and validation.
✔️Customized Project Design
We tailor analytical strategies to meet the specific needs of different drug substances, excipients, and formulations. Our workflows also consider regional regulatory requirements, ensuring compliance with country-specific guidelines.
Sample Submission Suggestions
1. Acceptable Sample Types: APIs, intermediates, excipients, raw materials, and finished dosage forms.
2. Sample Quantity: Typically 10–50 mg for solids and 1–10 mL for liquids, depending on analysis type.
3. Documentation: Include formulation details, stability requirements, and target impurities if known.
*Note: If you have special sample types or require additional guidance, please contact us for personalized support before sample preparation.
Deliverables
1. Comprehensive Experimental Records: Documentation of methods, validation, and controls.
2. Raw Data Files: Provided upon request for independent verification or audit purposes.
3. Chromatographic Profiles: HPLC, UPLC, or GC chromatograms of impurities.
4. Mass Spectra and Structural Data: LC-MS and GC-MS results with impurity identification.
5. Quantitative Results: Levels of impurities compared against regulatory thresholds.
6. Stability and Degradation Reports: Data from forced degradation and stability testing.
7. Final Report: A structured, publication- and submission-ready report with interpretations, regulatory references, and recommendations.
Related Services
Biopharmaceutical Stability Analysis Service
How to order?
