Through our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently as possible to maximize our customers' profits. For more information about our services, contact one of our experts today.
Note: this service is for Research Use Only and Not intended for clinical use.
Matters involving pharmaceutical products often require specific analysis of products performances such as stability, toxicological risk, impurities, solvent residual and other relevant items. At Alfa Chemistry , our clients can get the services of chemical or pharmaceutical analysis from experts to compare or differentiate the products at issue. To further support your strategic decisions about your case, our experts can experimentally answer critical and wide-ranging questions about the chemical composition and properties of pharmaceutical products. For matters involving biopharmaceutical products, we provide accurate, reliable technical expertise and comprehensive experimental solutions to answer critical questions about the properties of biopharmaceutical products.
Pharmaceutical impurity testing and assay are essential in the pharmaceutical industry to monitor the purity, safety and quality of drug substances and final drug formulations. Pharmaceutical impurities can be organic impurities (process- and drug-related) and inorganic or elemental impurities, which are generally presented at very low levels. Many sources such as starting materials, contaminants, reagents, catalysts, solvents and intermediates can give rise to pharmaceutical impurities. Moreover, impurities from excipients, leachables and degradation products can significantly impact the quality of drugs. To make a determination of the levels of pharmaceutical impurities, which are required for completing relevant risk assessments and supporting submission requirements, sensitive and specific assay methods will be offered by Alfa Chemistry . In summary, total quality assurance expertise from Alfa Chemistry can ensure you high quality services to meet the quality, safety and regulatory standards.
The scientists from Alfa Chemistry are adept at suitable analytical procedures, and the analytical technology and methods in our laboratory are fast, high-throughput, robust, and reproducible. We can overcome the challenges of low detection levels and difficult matrices to support your needs for pharmaceutical products performance analysis and impurity testing.
As one of the most important parts of a biotherapeutic pharmaceutical or a pharmaceutical's quality target product profile, stability is vital to determine how the critical quality attributes (CQAs) of both drug substances and products are changed by storage conditions. Subsequently, an optimized specific condition including temperature, relative humidity (RH), light, pH, and other factors can be provided based on the testing results. Besides, the stability tests performed by most manufacturers are also useful to investigate the degradation pathways and establish shelf lives of their pharmaceuticals. At Alfa Chemistry , the product stability testing will be conducted according to the type and intended use of your products. Importantly, your stability testing performed by our experts will be divided into various stages as follows: early stage stress and accelerated testing with drug substances; pre-formulated batch stability testing; scale-up batches stress testing; accelerated and long-term testing for registration purposes; ongoing stability testing and follow-up stability testing. To meet the special regulatory requirements, a suite of methods/technologies such as appearance analysis, SDS-PAGE, SEC/RP/IEX/HIC-HPLC and mass spectrometry are available in our laboratory.
Product failure analysis means that the mechanical, physical, and chemical investigation of the product no longer meet expectations or requirements. Failure analysis testing can be valuable in knowing the true causes of failure and improving engineering and management decisions. It is of great importance for manufactures to identify the causes of these failures quickly since product failures can lead to enormous economic losses and severe tarnish for their reputations. With advanced instrumentation such as SEM/EDXA, FT-IR, GC/MS, LC/MS, DSC, TGA and others, our excellent scientists can quickly identify the causes of your product failure and help you to develop an efficient solution that is able to prevent these failures. Specifically speaking, the failure analysis services that you can get form Alfa Chemistry mainly include but not limited to identifying the source of unknown impurities/contaminates, product recall investigations, investigations of premature product breakage and corrosion/contamination in manufacturing systems. Furthermore, to ensure your project is completed efficiently and timely, our experts in materials, chemistry, metallurgy, and mechanical testing will work with you through the entire process.
Toxicity of substances used in products represents a great potential risk that will result in enormous losses for drug manufactures in future. Not only for its unfavorable effect on individuals, brand integrity and a business's position in the marketplace, but also this issue can severely damage the profit of those pharmaceutical manufacturers. In this case, toxicological risk assessments are necessary in the present pharmaceutical market. Our analytical department will cooperate with other sectors to assess your product's potential toxicological risk by examination of pharmaceuticals and their ingredients, in vitro tests, animal studies and epidemiological data analysis. In addition, the toxicology consultants from Alfa Chemistry can work with you to find the optimal assessment strategy to mitigate risks at an early stage and prevent future hazards. By choosing the most appropriate testing methods and techniques, our experts will provide the most suitable services to meet the requirements of regulatory agencies across the world. Toxicological risk assessment of Alfa Chemistry is generally composed by hazard identification and data evaluation, exposure assessment, dose-response analysis and risk characterization. More importantly, we offer the services of toxicological risk assessment for products manufactured and sold in a wide range of industries.
During the biopharmaceutical product development, the substrates for cells growth, components of host cells and product variants should be identified and removed completely. However, process impurities such as host cell proteins, N-terminal truncations, host cell proteins, N-terminal truncations, host cell DNA, C-terminal integrity and host cell DNA still can be detected. According to the current regulatory guidance of USFDA, a new biopharmaceutical product should be conducted to identify its impurities and controlled them at a certain level. Therefore, the effective removal of process-related impurities or process residuals has a pivotal effect on the development of biopharmaceutical products. Alfa Chemistry can offer you a wide range of biopharmaceutical services that related to process impurities analysis. To ensure the levels of impurities in your biopharmaceutical products are under the safe amounts, highly sensitive analytical methods include commercial kit or customized assay, N-terminal sequencing, PCR, peptide mapping LC-MS or LC-MS/MS, SEC/SEC-MALLS and dynamic light scattering (DLS) are accessible for detection and quantification of these residuals.
Pharmaceutical development always involved with various complicated procedures from which impurities include chemical compounds, solvent residual, inorganic material and others components are derived. Given the significant role of these related process impurities in affecting the end product's quality, safety and even the reputation of the manufactures, efficient controlling of impurities content is necessary for pharmaceutical producers and is required by regulatory authority in majority counties. Alfa Chemistry is specialized in providing various customized analysis services for customers across the world. With a deep understanding of the pivotal role of impurities in product failures, we timely update the instrumentation in our laboratory to meet the requirements of latest legislation and rapid drug development. Therefore, the isolation, characterization and identification of organic or inorganic compounds can be conducted efficiently and economically by our purity testing laboratory. Furthermore, in order to meet your requirements of removing the impurities from your end products, our experts will work with you to develop an appropriate strategy with a wide range of analytical techniques such as FT-IR, NMR, LC/MS, GC/MS, ICP-MS and LC/MS.
During the production process of both pharmaceuticals and biopharmaceuticals, impurity profiling represents the essential quality control step. The unwanted organic impurities in pharmaceutical products are mainly arose during manufacture process and can be classified as starting materials, by-products, intermediates, degradation products, reagents, ligands or catalysts. Together with advanced technique platforms and informatics capabilities, our scientists are capable of understanding your special needs for unambiguous elemental composition and substructural information. To examine the presence of organic compounds in your products, a complete set of organic impurities test will be performed by our experts. A range of analytical workflows and techniques of Alfa Chemistry can support your needs for comprehensive impurity profiling including sample preparation, gas or liquid chromatography and mass spectrometry. By utilizing instrumentation such as FT-IR, LC/MS, NMR, GC/MS, TOF-SIMS and IC, our capability are includes structural analysis of organic components, qualitative and quantitative analysis of microscopic trace organic components, thermophysical properties evaluation of organic materials, generated gas and thermal desorption analysis.
Solvent residual in pharmaceuticals, generally defined as organic volatile chemicals, is produced during the process of fabricating drug substances or preparation of drug products and is considered to be a critical parameter in the development of pharmaceuticals. Incompletely removal of residual solvents from a product or intermediate may prevent pharmaceuticals free from toxicologically significant levels of volatile organic compounds. In this case, controlling the content of solvent residual in applied materials and final drug products represents a critical stage in your total pharmaceutical processes. At Alfa Chemistry , our experts have an extensive experience for comprehensive analysis of solvent residual to support your compliance testing. Besides, the typical headspace gas chromatography (GC) and mass spectrometry (GC-MS) will be used together for identification and quantification of your pharmaceutical products. Moreover, a complex chemometric modelling can be provided by our scientists for optimizing your API drying protocol and purifying methods. To meet the allowable limits of residual solvents required by ICH Q3C, various sophisticated techniques are equipped with valve and loop style headspace auto-samplers and gas chromatographs are assisted with flame ionization or mass spectrometric detection and compliant chromatography data software.
Elemental analysis and trace metals analysis have an essential role in the commercial release of pharmaceutical products and stability studies and the confirmation of product identity, purity and quality. Our analysts have extensive experience in pharmaceutical organic and inorganic elemental analysis. To support your product identity, purity, quality and clinical trial, the team from Alfa Chemistry provides a full range of elemental analysis and trace metals analysis with coverage of almost the entire periodic table from trace levels to percent levels. Scientists from our laboratory are able to provide you the most suitable and phase – appropriate analytical package services for your product development. Additionally, to meet the quality, safety and regulatory standards, we can also offer our clients with method development and validation. With a range of analytical technologies include optical emission spectroscopy (ICP-OES), ion chromatography (IC), flame atomic absorption spectroscopy (FLAA) and X-ray fluorescence (XRF), Alfa Chemistry can provide Total Quality Assurance expertise to help you develop a strategic approach for supporting your testing needs.
In addition to the process-related impurities, component degradation also represents one of the major causes of product failure, increased impurities and changes in physicochemical properties. Generally, these impurities are presented in products at very low levels, which is a great challenge for the efficient detection and separation. The experts from Alfa Chemistry , who are adept at development of sensitive and specific assay methods, have a decade of experience in pharmaceutical analysis and safety assessment. Based on the extensive expertise and a variety of sophisticated technique platforms, we are confident in providing full range of evaluation of purity, safety and quality for your drug products.
Identification and quantification of harmful extractable or leachable impurities are critical in the pharmaceutical development since these impurities have a contaminative effect on the final pharmaceutical products. Our scientists conduct studies on extractables and leachables in accordance with regional guidance and corresponding guidelines. Through application of a variety of instrumentation such as HPLC, LC-MS, GC, GC-MS and ICP or ICP-MS, Alfa Chemistry can work with our customers to determine both organic and inorganic contaminants. As a professional company specializing in glass delamination studies, our laboratory provides a range of solutions for decreasing the risks associated glass delamination and preventing the leaching of metal ions or elemental impurities from glass into your pharmaceutical products. In order to identify and address the potential risks related to your products, our experienced scientists will assist you to make a comprehensive evaluation and safety assessment review. In addition, our in-house toxicologist consultants will offer recommendations to further support you in preparation of very low-risk data packages that related to extractables and leachables tests.
Do not know how to place an order, please refer to the flow chart shown below.
Submit quotation request |
A technical manager will contact you within 24 hours |
You will review and approve the final price and place an order |
Confirm with you and make the payment |
Instruct you to ship your samples and form |
Analytic report delivery |