Pharmaceutical Impurities And Elemental Analysis Service
In modern pharmaceutical development, production, and quality control, impurity analysis is a critical step to ensure drug safety, efficacy, and regulatory compliance. Pharmacopeias and ICH guidelines around the world have established strict limits and methodological requirements for organic impurities, elemental impurities, residual solvents, and degradation products in drug substances and products. Rapid and accurate identification and quantification of these impurities—while maintaining regulatory alignment—remains a key challenge in drug development and regulatory submission.
MtoZ Biolabs is a comprehensive CRO specializing in chromatography and mass spectrometry technologies. Leveraging a multi-platform approach including XRF, ICP-MS, IC, EA, TOC/TN, and PY-GCMS, we offer a standardized, end-to-end Pharmaceutical Impurities and Elemental Analysis Service, supporting our clients across method development, impurity profiling, and data reporting to meet growing regulatory demands and stringent quality standards.
Services at MtoZ Biolabs
MtoZ Biolabs utilizes multiple advanced analytical platforms for impurity and elemental analysis, suitable for a wide range of sample types including small-molecule drugs, biologics, excipients, APIs, and intermediates. Our services include but are not limited to:
Utilizing X-ray fluorescence spectroscopy, this service enables rapid screening of heavy metals and inorganic elements in raw materials and intermediates. It requires no sample digestion, supports non-destructive testing of powders and solids, and is ideal for elemental composition screening and preliminary impurity profiling.
Ion Chromatography Testing Service
This service provides high-sensitivity detection of inorganic ions, organic acids, and cleaning agent residues. It is widely applied in raw materials, intermediates, and formulations to support purification process monitoring and residual analysis, contributing to improved product purity and compliance.
ICP-MS and ICP-OES Testing Services
Using ICP-MS and ICP-OES technologies, we deliver high-sensitivity quantification of trace metals and rare earth elements. Suitable for evaluating elemental impurity levels in APIs, excipients, and drug products, these services meet regulatory limits for impurity control and support multi-element simultaneous detection down to trace levels.
Organic Element Analyzer (EA) Analytical Service
This service employs organic elemental analysis instruments to accurately measure carbon (C), hydrogen (H), nitrogen (N), and sulfur (S) content in drug substances. It is ideal for confirming molecular composition, verifying elemental ratios, and evaluating sample purity, particularly during structure elucidation and impurity investigation.
Based on total organic carbon (TOC) and total nitrogen (TN) analysis, this service detects trace organic and nitrogenous contaminants in aqueous systems. Common applications include monitoring injection water, cleaning validation extracts, excipients, and formulation residues—supporting cleaning process verification, environmental surveillance, and carbon-nitrogen load evaluation in biological samples.
Pyrolysis-GC-MS Analytical Service
Built on pyrolysis-gas chromatography-mass spectrometry technology, this service offers rapid analysis of polymers, unknown organic impurities, and thermally unstable degradation products. It is widely used for identifying additives in packaging materials, extractables/leachables studies, and profiling non-volatile organic residues in complex formulations.
Analysis Workflow
Service Advantages
1. Comprehensive Analytical Platforms
MtoZ Biolabs offers a broad range of technologies including XRF, ICP-MS, IC, EA, PY-GCMS, and TOC, enabling multi-dimensional detection of elemental, organic, and ionic impurities. This ensures thorough impurity profiling across the drug development lifecycle.
2. Standards-Aligned Methodologies
Our analytical procedures follow internationally recognized pharmaceutical quality standards, ensuring data consistency, reproducibility, and reliability to support research, manufacturing, and regulatory applications.
3. Broad Sample Compatibility
We accommodate diverse sample types—APIs, intermediates, formulations, and excipients—and provide robust handling solutions for challenging matrices such as high-salt, viscous, or organic solvent-based samples, ensuring data accuracy.
4. Rigorous Data Management
All procedures are SOP-based and tracked through digital LIMS systems to ensure traceability, data integrity, and audit readiness, aligning with strict quality system and review expectations.
5. Expert Technical Support
Our analytical team brings extensive experience in pharmaceutical impurity analysis and method development, offering consultation, customized study design, and data interpretation to help clients advance projects efficiently.
Applications
1. Impurity identification in small molecule drugs and formulations
2. Residual analysis and impurity control in biologics
3. Elemental impurity evaluation aligned with ICH Q3D
4. Degradation pathway studies and stability monitoring
5. Cleaning validation and contamination assessment
6. Support for generic drug equivalence and regulatory submission
FAQ
Q1: What is the typical turnaround time?
Most testing projects are completed within 5–10 business days. Timelines may vary based on sample complexity.
Q2: Are your reports suitable for regulatory submission?
Yes. We offer validated methods and standardized report formats compliant with regulatory expectations for submission or inquiry response.
Q3: Can you handle complex or non-standard matrices?
Yes. Our experience includes high-salt, high-fat, or solvent-rich matrices, supported by optimized pretreatment protocols.
Q4: How much sample should I provide?
Typically, ≥1 mL for liquids and 50 mg–1 g for solids. We will confirm exact requirements during project consultation.
Q5: Do you offer method development or validation?
Yes. We provide method development, transfer, and validation services as needed for different R&D or regulatory stages.
Sample Submission Suggestions
1. Clearly label each sample with name, batch number, dosage form, and concentration
2. Provide solvent and pH information for liquid samples
3. Use clean, sealed containers to avoid contamination
4. For light- or temperature-sensitive samples, use dry ice or light-shielded transport
5. Include safety data sheet or relevant safety documentation for special samples
As pharmaceutical quality standards rise and global regulations become more stringent, a reliable impurity and elemental analysis partner is essential to ensure product compliance and market success. MtoZ Biolabs, through our integrated technology platforms and experienced scientific team, delivers efficient, regulatory-ready Pharmaceutical Impurities and Elemental Analysis Services to support your drug development and registration journey. Contact us today to receive a customized analytical solution tailored to your project needs.
How to order?
