Metrohm NIRS XDS MasterLab AnalyzerRapid, nondestructive analyses of tablets, capsules and other solid-state dosage forms
Pharmaceutical quality control and analysis labs must comply with Pharmacopoeia specifications. The process is critical from early stage drug development, to formulations and to release. DKSH services the Asia Pacific market with a wide offering of instruments and consumables from industry leaders, ensuring your continued GMP and local regulatory compliance. Browse our portfolios in Chemical Testing, Physical Testing and Microbiological Testing.
Testing of incoming raw materials is an essential step in the manufacturing of pharmaceutical products, as to guarantee safety and efficacy of a finished dosage form, which is largely dependent on the purity and quality of the bulk active drug substance and excipient. It is key to have a high-throughput method for analyzing the sample in a loading bay or warehouse, while also preventing sample exposure to contaminants.
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To ensure the safety and quality before releasing the drug to the market, pharmaceutical companies must evaluate the interactions between packaging material and formulation. Extractables and leachables studies are key indicators for product quality during drug development and final batch release. The testing process assesses whether the drug products could have been exposed to harmful leachable contaminants.
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Organic impurities can arise in APIs or drug product formulations during the manufacturing process or during the storage of drug substances. This includes volatile or nonvolatile compounds from starting materials, intermediates, unintended byproducts and degradation products. Organic impurities most often result in undesired biological activity or toxicity.
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Trace amounts of residual solvents can be found in pharmaceutical products used during drug production. Strict regulations on monitoring the presence of residual solvents is required as even the most trace amount can impact drug safety and efficacy.
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In accordance with Pharmacopoeias, for reasons of patient safety, the heavy metals in pharmaceutical finished products and raw materials must not exceed specified limit values. Heavy metals can be introduced into the product via catalysts, synthesis reagents and through contaminants in the manufacturing process.
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Stability testing provides evidence on how the quality of a drug substance or product varies with time. Testing is performed under the influence of environmental factors such as temperature, humidity and light. The studies are designed to include testing of attributes susceptible to change during storage and are likely to influence quality, safety and efficacy. Stability conditions are governed by the International Conference on Harmonization (ICH).
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Moisture content affects the processability, shelf-life, usability and quality of a product. Accurate moisture content determination therefore plays a key role in ensuring quality in pharmaceuticals.
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Polarimetry is used in pharmaceutical industries for purity control and determination of concentration of substances. Testing is performed according to the requirements of Pharmacopeias by measurement of both specific and optical rotation.
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Physical testing refers to the monitoring of physical characteristics of a drug product or drug components and can be categorized into microscopic and macroscopic physical characteristics. At the microscopic level, the particle size and morphology are measured by dynamic light scattering, which affect the absorption, dissolution, and content uniformity in the bulk. At the macroscopic level, drugs are typically manufactured in oral dosage forms such as tablets and capsules, or liquid forms such as oral liquid forms, topical/ointments, and injectables. Macroscopic physical testing examines the physical attributes of the drug form, such as dissolution, disintegration, powder flowability, liquid viscosity, tablet dimensions, friability, and tablet breaking force. Physical testing is performed on raw materials, intermediaries, and final product stages.
Particle size determination by Laser Diffraction and Dynamic Light Scattering has been an industry standard for the past decade. The pharmaceutical industry measures particle size to control product quality and efficacy.
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Dissolution, or drug release, measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.
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Disintegration is the process of breaking down a solid dosage form into granules of a specified size, under a specified condition. When dosage forms are disintegrated, dissolution rate increases.
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Various forms of solid dosage forms will be tested on tablet breaking force, friability, powder flow and melting point as required by Pharmacopeias.
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The viscosity will affect the flow behavior of pharmaceutical products. It is relevant to the pumping, filling and finish and injectability, and is characterized for liquid or semi-solid drugs.
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Microbiological testing in all stages and environments of the pharmaceutical manufacturing workflow is important. It is a set of protocols that tests for contaminations that may be harmful to patient safety. The goal of this family of testing is to provide a monitoring framework for all possible microbiological contaminants throughout the manufacturing process.
Sterility testing is the monitoring of microbial contamination via the Membrane Filtration or Direct Inoculation method.
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A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.
Culture media must be robust enough to withstand the rigorous conditions in today’s pharmaceutical cleanrooms. Culture media needs to be both reliable and sensitive to promptly detect stressed organisms inherent to aseptic manufacturing areas.
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Regular environmental monitoring of samples for microbiological quality must be performed at various defined locations in pharmaceutical facilities. It is a very critical measure for controlling clean areas and environments, which has a direct impact on the microbiological quality of the final pharmaceutical products.
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Bacterial endotoxins are remnants of bacterial cells and are not detected by a sterility test. Potential sources of endotoxins include water, packaging components, equipment and chemical/raw materials used during compounding of a drug product. Traditionally performed with LAL Assays, new-generation recombinant Cascade Reagent (rCR) Assays are now Horseshoe Crab Blood free.
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