Analysis Services
BOC Sciences is committed to providing our customers with a series of analysis services with rich experience and excellent team. The completion of a project requires the assistance and cooperation of multiple departments, and we have such capabilities. We believe that the cooperation with us will find the most efficient solution for your project.
Our Drug Analysis Services
BOC Sciences' drug analysis platform can provide customers with one-stop drug analysis services based on ICH guidelines and relevant requirements of the International Pharmacopoeia. The service scope covers the quality research of chemical drugs, peptide drugs and their preparations, as well as the method development and verification of elemental impurities. We have comprehensive and advanced equipment and facilities, an experienced professional team, and a complete quality and project management system. We can develop individualized plans based on customer needs and project conditions.
Method Development & Validation
We are good at method development and verification of small molecule APIs & intermediates and chemical macromolecules. It mainly starts with component analysis, purity analysis and structural analysis, allowing you to understand the overall quality from raw materials to final products. Our analysis method is absolutely efficient and the results are reliable. Our analytical techniquesis equipped with comprehensive and advanced pharmaceutical analysis equipment, with hundreds of analytical instruments, including HPLC, UPLC, GC, GC-MS, LC-MS, ICP-MS, triple quadrupole, etc.
Stability Study
In order to study the changes in the physical, chemical, biological and microbiological properties of products under the influence of various environmental factors (such as temperature, humidity, etc.), stability studies are required. Our stability research mainly includes influencing factor test, accelerated test and long-term test, etc. The specific experimental plan will be filled in according to the details of the project. All analytical methods will be methodologically validated. Finally, we will organize all the experimental data and evaluation results into a complete report.
Microbial Detection
Microbiological testing is an important part of drug quality control. Our microbiological testing laboratory has passed standard certification, which can guarantee the accuracy of test results. Our services include sterility testing, non-sterile product microbial limit inspection, biological indicator total spore count determination, microbial count, antibacterial effectiveness test, microbial recovery rate verification, endotoxin test and mycoplasma test, etc. Our microbiology experts are proficient in the pharmacopoeias of various countries and can provide you with the most comprehensive testing program.
Impurity Research
Impurities in the drug will directly affect the purity and further affect the safety of the drug. Through our analysis and testing, we can accurately determine the content of impurities and determine the reasonable limits of impurities. Our detection methods include chemical methods, spectroscopy, chromatography, heavy metal limit inspection, atomic absorption spectrophotometry, colorimetry, etc. All impurity tests will be fully recorded and placed in your exclusive project database.
Physical & Chemical Testing
The research on the physical and chemical properties of drugs runs through the entire process of drug development and production. Our analysis includes particle size, potential, surface area, density, porosity, powder rheology and fluidity characterization, differential scanning calorimetry (DSC and TGA) and adsorption capacity. The more comprehensive the physical and chemical properties mastered, the more efficient the process adjustment and quality assurance. Therefore, we focus on expanding our physical and chemical analysis methods, continue to expand our professional advantages in the entire industry, and provide you with better analysis services.
In addition to the above analysis services, BOC Sciences can also provide services such as trace metal analysis, specific activity analysis, and toxicity analysis. Our analysis laboratory meets cGMP certification and is equipped with various advanced instruments and equipment. We hope to accelerate your development and manufacturing process through powerful analysis capabilities.
Our Quality Research Capabilities
Chemical Drugs and Their Preparations
- Development and validation of analytical methods for substances related to in vitro release testing (IVRT) and in vitro transdermal testing (IVPT).
- Development and validation of analytical methods for residual solvents.
- Development and validation of analytical methods for content determination.
- Development and validation of isomer analysis methods.
- Development and validation of dissolution assay methods.
- Development and validation of rheological characterization methods.
- Stability studies.
Peptide Drugs and Their Preparations
- Method development and validation for racemic and isomeric impurities.
- Method development and validation for amino acid ratios.
- Method development and validation for related substances.
- Method development and validation for counter ion.
- Method development and validation for polymer.
- Assay method development and validation.
- Stability studies.
Case Study
A pharmaceutical company provided BOC Sciences with a compounded dosage form that had stability issues. The company observed unexpected changes in the drug's physical appearance and potency overtime, leading to concerns about the presence of impurities in the formulation. BOC Sciences performs a comprehensive analysis of the compounded dosage form to identify and quantify any impurities present.
Methods: BOC Sciences utilized a combination of analytical techniques including high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and nuclear magnetic resonance (NMR) to identify impurities in compounded dosage forms. Our team also performed stress testing and accelerated stability studies to simulate conditions that could lead to impurity formation.
Results: Through analysis, BOC Sciences identified multiple impurities in the compounded dosage form, including degradation products of the active pharmaceutical ingredient and by-products of excipients used in the formulation. The team identified the root causes of impurity formation, such as exposure to light, heat and moisture during storage and handling. Based on these findings, BOC Sciences recommended formulation and packaging modifications to minimize impurity formation and improve drug product stability.
FAQ
1. What is drug analysis?
Drug analysis is based on drug quality standards to detect and analyze the relevant ingredients and contents in drugs to evaluate the quality and authenticity of the drugs. Drug analysis and testing can study the composition, physical and chemical properties, authenticity identification, purity inspection and content of active ingredients of drugs and their preparations, and ensure that people use drugs safely, reasonably and effectively. Before carrying out drug analysis, it is necessary to be equipped with suitable drug quality testing equipment and other instruments, which is the basis for ensuring the development of drug quality inspection work. When conducting drug analysis, it is necessary to strictly abide by the inspection operation procedures to ensure that the drug quality test results are accurate and reliable.
2. What are the methods of drug analysis?
Drug analysis is a critical process involving the identification, quantification, and evaluation of drugs and their metabolites in biological samples. One of the most commonly used methods for drug analysis is chromatography, including gas chromatography (GC) and high-performance liquid chromatography (HPLC), which are widely used in drug analysis. In addition, MS is often used in conjunction with chromatography to improve the sensitivity and selectivity of pharmaceutical analysis. There are several types of MS, including liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS), which are commonly used for pharmaceutical analysis. MS has high sensitivity and can detect drugs at very low concentrations, making it an important tool for drug analysis.
3. What is the principle of drug analysis?
Samples for drug quality inspection include samples of medicinal raw materials, excipients, semi-finished products, packaging materials, waste generated during the production process, and materials directly or indirectly related to drugs. Inspection samples and methods need to be verified by relevant authorized personnel and drug inspection personnel in accordance with regulations, and the inspection report must be recorded and completed and submitted for review in a timely manner. Drug analysis and testing are crucial to drug research and development. Through drug analysis methods, the efficacy, main ingredients, and physical and chemical properties of the drug can be understood.
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Analysis Techniques
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