API Analysis Service
Active Pharmaceutical Ingredients (APIs) form the foundation of every drug product, providing the pharmacologically active component that delivers therapeutic efficacy. Whether the API is derived from chemical synthesis, fermentation, plant extraction, or biotechnological expression, ensuring its purity, potency, stability, and safety is essential throughout drug discovery, development, and commercialization.
API analysis is the systematic evaluation of the composition, identity, structural integrity, and quality attributes of active pharmaceutical substances. This process helps to confirm that the API meets regulatory expectations and is suitable for incorporation into finished dosage forms. API characterization involves the integration of diverse analytical technologies to evaluate physical, chemical, and biological properties, ensuring consistency across production batches and throughout the product's lifecycle.
The complexity of APIs varies significantly. While small molecules are relatively straightforward, biologics such as peptides, proteins, and nucleic acid-based APIs present much greater structural diversity and sensitivity to environmental conditions. Impurities, degradation products, polymorphic forms, and excipient interactions may all influence the performance of APIs. Therefore, comprehensive testing strategies are required to establish the quality, safety, and efficacy of pharmaceutical actives.
Service at MtoZ Biolabs
MtoZ Biolabs offers specialized API Analysis Services to address these challenges. Our API Analysis Service portfolio combines advanced chromatographic, spectroscopic, and mass spectrometric platforms with validated methodologies to deliver accurate, reliable, and regulatory-compliant results. By partnering with us, clients benefit from end-to-end analytical solutions that support drug discovery, clinical development, manufacturing, and regulatory submissions.
| Service Item | Analytical Methods | Purpose |
| Identity Confirmation | MS, NMR, FTIR, UV | Confirms molecular weight, structure, stereochemistry, functional groups, and chromophore-related features to verify API identity. |
| Purity and Impurity Profiling | HPLC, UPLC, GC, LC-MS, ICP-MS | Detects and quantifies process-related impurities, residual solvents, elemental impurities, and degradation products for safety and quality. |
| API Potency and Content Uniformity | HPLC, UPLC, UV | Quantifies API concentration in bulk and formulations; ensures uniform distribution of active ingredients across batches. |
| Stability Studies | DSC, TGA, chromatography and spectroscopy | Identifies degradation products and pathways under heat, light, oxidative, and humidity stress to define shelf life and packaging needs. |
| Microbial Contamination Testing | Plate culture methods, membrane filtration, MPN assays, selective media | Determines total aerobic microbial count, yeast and mold levels, and presence of specific pathogens to ensure microbial safety and compliance. |
| Custom API Analysis | Tailored workflows | Reports are customized to align with the unique needs of the project and the regulatory expectations of different regions. |
Analysis Workflow
Why Choose MtoZ Biolabs?
✔️Comprehensive analytical platforms combining MS, NMR, HPLC, GC, FTIR, UV, DSC, and bioassays.
✔️Highly experienced scientific team with expertise in both small molecule and biologic APIs.
✔️Customized workflows and reports designed to meet project-specific and regional regulatory requirements.
✔️Stringent quality management system ensuring data accuracy, reproducibility, and reliability.
✔️End-to-end solutions covering sample preparation, analytical testing, data processing, and result interpretation.
✔️Fast turnaround times without compromising quality.
Applications
API analysis is critical in multiple contexts across the pharmaceutical industry. Our service supports:
1. Drug Discovery and Development
Early identification of active structures and optimization of synthetic or biotechnological processes.
2. Process Development and Scale-Up
Monitoring impurities and ensuring consistent product quality during manufacturing scale-up.
3. Formulation Development
Understanding API-excipient interactions and stability under formulation conditions.
4. Regulatory Compliance
Providing validated analytical data packages required by global regulatory authorities for drug approval.
5. Quality Control
Routine analysis for batch release, ensuring compliance with established specifications.
6. Comparative Studies for Generics and Biosimilars
Structural and compositional analysis to demonstrate equivalence with reference products.
Sample Submission Suggestions
1. Solid APIs: Provide at least 50 mg of sample in sealed, inert containers.
2. Liquid APIs: Minimum 1 mL of solution, stored in appropriate solvent-resistant containers.
3. Biologic APIs: Provide 200–500 µg of protein or peptide, frozen at –80 °C and shipped on dry ice.
4. Stability and Stress Samples: Provide duplicate aliquots stored under relevant conditions.
*Note: If you have special sample types or require additional guidance, please contact us for personalized support before sample preparation.
Deliverables
1. Comprehensive documentation of analytical procedures and methods used.
2. Raw and processed data outputs, such as chromatograms, spectra, and mass profiles.
3. Identification and quantification of APIs, impurities, and degradation products.
4. Structural confirmation reports including NMR, MS, and crystallographic data where applicable.
5. Stability profiles with interpretation of degradation pathways.
6. Customized final report tailored to client and regulatory requirements.
Free project evaluation, welcome to learn more details!
Related Services
Drug Composition Testing Service
Drug Microbial Limit Testing Service
Pharmaceutical Impurity Analysis Service
How to order?
