Drug Composition Testing Service
Drug composition testing is an essential part of pharmaceutical research, development, and quality control. It refers to the comprehensive analysis of the components that make up a drug substance or product, including the active pharmaceutical ingredients (APIs), excipients, residual solvents, degradation products, and potential contaminants. Understanding the exact composition of a drug is critical for ensuring product safety, efficacy, stability, and compliance with regulatory standards.
Pharmaceuticals are highly complex, and their therapeutic performance depends not only on the API but also on the purity, integrity, and consistency of the entire formulation. Accurate composition testing prevents batch-to-batch variability, safeguards against adulteration, and supports reliable therapeutic outcomes. It also helps identify unwanted substances that may impact drug safety, including residual catalysts, heavy metals, or microbial contaminants.
MtoZ Biolabs offers a comprehensive Drug Composition Testing Service that integrates state-of-the-art instrumentation with expert data interpretation. Our Drug Composition Testing Services help pharmaceutical companies ensure product quality, comply with international standards, and accelerate the path from research to commercialization.
Service at MtoZ Biolabs
MtoZ Biolabs is capable of testing a wide range of pharmaceutical components, including vitamins, melatonin, caffeine, oxymatrine, total saponins, inositol, lovastatin, soy isoflavone, chondroitin sulfate, silymarin, and mineral substances, among many others. This broad coverage ensures that both small-molecule and natural product-based formulations can be accurately characterized and validated.
Our Drug Composition Testing Service integrates multiple complementary analytical technologies to ensure a full understanding of drug composition:
🔸Chromatographic Techniques (HPLC, UPLC, GC)
High-resolution separation and quantification of APIs, excipients, residual solvents, and degradation products.
🔸Mass Spectrometry (LC-MS, GC-MS)
Accurate determination of molecular weights, impurity profiles, and structural confirmation of key components.
🔸Spectroscopic Approaches (NMR, FTIR, UV)
Functional group identification, stereochemical analysis, and molecular fingerprinting for complex compounds.
🔸Elemental Analysis (ICP-MS)
Sensitive quantification of trace metals, catalysts, and other elemental impurities.
Analysis Workflow
Service Advantages
☑️Advanced multi-platform analytical capability integrating MS, HPLC-MS/MS, and GC for comprehensive composition profiling
☑️Experienced scientific team with strong expertise in pharmaceutical composition analysis and quality evaluation
☑️Deliver tailored reports according to project-specific needs and regional regulatory requirements
☑️Strict quality control systems ensuring reliable and reproducible results
☑️Efficient turnaround times supported by optimized laboratory processes
Applications
1. Drug Discovery and Development
Structural confirmation and compositional profiling of new molecular entities and formulations.
2. Quality Control and Assurance
Ensuring batch consistency, detecting contaminants, and validating production processes.
3. Regulatory Submissions
Providing validated compositional data packages for submission to regulatory authorities, supporting compliance and product approval.
4. Generic Drug Development
Comparative composition testing to establish equivalence with reference products.
5. Biopharmaceutical Analysis
Characterization of proteins, peptides, and biologics for post-translational modifications and excipient interactions.
Sample Submission Suggestions
Our Drug Composition Testing Service accepts a wide variety of samples, including but not limited to:
1. Pharmaceuticals: Chemical raw materials, finished formulations, antibiotics, vaccines, antipyretics, analgesics, antiviral drugs, antitumor agents, and hormone-based therapies.
2. Veterinary Drugs: Rodenticides, lincomycin derivatives, tetracyclines, antiparasitic agents, sulfonamides, macrolides, and veterinary vaccines.
3. Pesticides: Insecticides, fungicides, acaricides, plant growth regulators, herbicides, nematicides, and seed treatment agents.
*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 experimental design, procedures, and quality control steps
2. Raw and processed analytical data
3. Spectra, chromatograms, or mass profiles
4. Summary of key compositional attributes, including identification and quantification results as well as impurity profiles
5. Tailored reports
Free project evaluation, welcome to learn more details!
Related Services
Drug Microbial Limit Testing Service
Pharmaceutical Impurity Analysis Service
How to order?
