Analytical quality control, commonly referred to as AQC, refers to all processes and procedures designed to ensure consistency, comparability, and accuracy of laboratory analysis results within a specified range of accuracy. The composition submitted to the analytical laboratory must be accurately described in order to avoid misinterpretation, approximation, qualitative and quantitative data generated by the laboratory can be used for decision-making. In the chemical sense, quantitative analysis refers to the measurement of the number or concentration of elements or compounds in a matrix different from elements or compounds. Analytical method development services and quality control testing support all stages of product and process development, from raw materials to commercial batch release, is the key to the success of the final product.
CMC is involved in all stages of the drug development life cycle after drug discovery. During preclinical drug development, correct analytical methods are validated to monitor the product. The stability test can be carried out, the physical and chemical properties of the product can be determined, the raw materials can be selected and tested. As drug development progresses, additional analytical methods are refined and further characterization of drug substances and products is required. During scale-up, it is essential to ensure that larger production batches remain consistent with earlier-stage materials and meet predefined quality specifications. Once the manufacturing process is standardized, routine batch release testing is implemented to ensure continued product consistency and reliability.
An essential component of any biopharmaceutical development plan is analysis. To support manufacturing, product release, and stability evaluation, biopharmaceuticals require a range of appropriate analytical techniques that are reliable, reproducible, and suitable for use in controlled production settings. BOC Sciences' CMC services, backed by extensive experience in release and stability testing, can address all your analytical development needs—whether physical, chemical, or biological. The significant support and trouble-shooting capabilities of the analytical sector including: Method Development and Validation, Analytical Testing and Release, Stability Study and Regulatory CMC Documentation.
Quality control is a set of methods to maintain standards in a production line or process. Quality control can be applied to methods, equipment, processes or products, usually involving on-site testing or products or procedures to ensure that standards are maintained. According to industry-recognized best practices, drug quality controlled release and stability testing are supported through analytical method development and advanced stability testing. Drug quality control teams can help determine the shelf life and specifications of drugs and develop drug control strategies, as well as the design of "by design quality" and "breakthrough treatment programs".
Our finished dosage form analysis ensures product quality and performance through precise evaluation of critical parameters. Content uniformity testing verifies consistent distribution of active ingredients across dosage units, guaranteeing dosage accuracy. Disintegration and dissolution testing assess the rate and extent of drug release, providing essential information on product behavior. Particle size and dispersibility testing characterize powder or suspension properties, which influence dissolution and stability. Together, these analyses enable comprehensive quality control to support reliable product performance throughout the product lifecycle.
Specialized dosage forms require tailored analytical strategies to address unique formulation challenges. Microsphere, liposome, and nano-formulation testing focus on encapsulation efficiency, particle size distribution, and release kinetics, critical for targeted drug delivery. Injectables testing ensures sterility, particulate matter control, and physicochemical stability to meet stringent safety requirements. Inhalation product testing evaluates aerosol performance, particle size, and dose uniformity for effective pulmonary administration. Transdermal and gel formulations are assessed for permeation, viscosity, and stability, ensuring consistent therapeutic delivery. Our platform integrates advanced methodologies to support development and commercialization of complex dosage forms.
Chromatography methods such as HPLC, GC, and LC-MS are essential for separating, identifying, and quantifying active ingredients, impurities, and degradation products. These techniques offer high sensitivity and specificity, making them indispensable in analytical development and quality control across all stages of drug research, formulation, and manufacturing.
Spectroscopic tools like UV-Vis, FTIR, NMR, and AAS enable rapid and non-destructive analysis of molecular structure, functional groups, and elemental composition. These methods support identity verification, structural elucidation, and quantitative analysis, offering valuable insight into raw materials and drug substances throughout the development lifecycle.
Physicochemical methods assess fundamental properties such as pH, conductivity, osmolality, and melting point. These parameters are critical for evaluating formulation stability, process control, and compliance with pharmacopeial specifications, especially for injectable solutions, oral liquids, and solid dosage forms.
Titration techniques, including acid-base, redox, and non-aqueous titrations, are reliable tools for quantitative analysis of APIs and excipients. These methods are widely used due to their accuracy, simplicity, and suitability for routine QC testing of pharmaceutical raw materials and finished products.
Water content significantly affects product stability and shelf life. Karl Fischer titration and loss on drying (LOD) methods are routinely employed to measure moisture and volatile components. These techniques ensure compliance with specifications and support long-term product quality assurance.
Thermal analysis methods such as DSC and TGA assess a compound's thermal behavior, including melting point, crystallinity, and decomposition profile. These techniques are vital for pre-formulation studies, polymorph screening, and ensuring thermal stability during production and storage.
Sterile products require stringent microbial and particulate testing. Methods such as endotoxin detection, sterility testing, and sub-visible particulate analysis ensure safety and consistency for injectables and biologics. These tests are integral to quality control processes in sterile product development and manufacturing.
Dissolution testing, stability-indicating assays, and degradation profiling are essential for evaluating drug release characteristics and product shelf-life. These analytical methods provide critical data to ensure that drug products maintain consistent potency and performance throughout their intended use period, supporting effective product management and quality assurance.
BOC Sciences has the capability to deliver high-precision chiral analysis, separation, and purification services through a wide range of advanced technologies. We possess extensive expertise in handling complex compounds, ensuring optimal purity and structural integrity at every stage of development. Our state-of-the-art techniques allow us to efficiently address a broad spectrum of analytical needs, from enantiomeric identification and purification to large-scale compound synthesis and quality control. With our comprehensive approach, we are equipped to support both small-scale research and large-scale manufacturing projects, ensuring reliable and reproducible results.
We begin by thoroughly understanding the client's product characteristics and analysis requirements, developing a tailored analytical development plan.
Appropriate analytical methods are selected based on product characteristics, followed by optimization to enhance sensitivity, accuracy, and reproducibility.
Analytical methods are rigorously validated in accordance with internal standards, ensuring accuracy, precision, specificity, and linearity across the required range.
Samples are analyzed using the validated methods, with systematic data recording to ensure integrity and reliability throughout the process.
Results are thoroughly reviewed, and detailed technical reports are compiled to support decision-making and meet client specifications.
We track the performance of analytical methods and conduct regular quality control to ensure stability and continuous improvement over time.
BOC Sciences' end-to-end services are characterized by high quality and fast turnaround time. In addition to the cost-effective solutions, the one-stop services are also available to meet all the needs including analytical & stability, quality control and regulatory CMC documentation. Importantly, the provided package services are qualified for all over the world.
Our expert team brings years of specialized experience in analytical method development, ensuring high-quality and reliable results for every project.
We leverage state-of-the-art instruments like HPLC, NMR, and Mass Spectrometry to provide precise, reproducible, and highly accurate analytical data.
We design tailored analytical strategies to meet specific client requirements, from initial development through to product validation, ensuring efficiency at every stage.
Our optimized workflows and advanced equipment ensure rapid data generation and analysis, minimizing project timelines and maximizing productivity.
With rigorous quality control at every step, we ensure that our analytical methods deliver consistent and trustworthy results across multiple batches and scales.
By applying cutting-edge technology and efficient processes, we offer cost-effective analytical solutions without compromising on quality or accuracy.
Yes, quality control is a core component of the analytical phase. The analytical phase involves the actual measurement and evaluation of samples using validated methods, and quality control is the structured process by which these analyses are conducted to verify that products meet established quality specifications. This includes sample preparation, method execution, data acquisition, and comparison of results against predefined acceptance criteria. Therefore, quality control not only belongs to the analytical phase but also plays a critical role in ensuring consistent product quality and supporting release decisions.
Analytical development and quality control play a vital role in pharmaceutical and biochemical manufacturing by ensuring consistent product quality and reliable characterization of raw materials, intermediates, and final products. Robust analytical methods enable accurate identification and quantification, while quality control monitors batch consistency and detects deviations. At BOC Sciences, our integrated analytical development and quality control services help clients optimize processes, reduce risks, and generate precise data that support efficient product manufacturing and release.
BOC Sciences offers a comprehensive portfolio of analytical methods designed to meet diverse quality control requirements. These include high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), UV-Vis and FTIR spectroscopy, Karl Fischer titration, elemental analysis, and others. Our experienced team applies validated methods to deliver accurate and reproducible results, supporting product development, manufacturing control, and final product evaluation across small molecules, biologics, and complex APIs.
Requesting a quote from BOC Sciences is simple and efficient. You can submit your project details through our online inquiry form. Our experts will promptly review your requirements and provide a customized proposal, including recommended methods, timelines, and cost estimates. We are committed to supporting your analytical needs with flexible, high-quality, and cost-effective solutions.
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