Hygroscopicity of a material can be regarded as a physicochemical property that represents the ability of absorbing moisture from the surrounding environment. Recently, the determination of the hygroscopicity is of great importance to select the most appropriate solid form of a drug substance for development. The pivotal effect of hygroscopicity evaluation in pharmaceutical development is mainly ascribed to the fact that the absorbed moisture may lead to significant adverse effects on the physical and chemical stability of the end products. For pharmaceutical development, the moisture sorption evaluation is always conducted during the early stages to optimize the formulation parameters, manufacturing process, and establish a storage condition for the drug substances or end products.
At BOC Sciences, we understand that moisture-sensitive materials can create significant challenges at every stage of product development, manufacturing, and storage. Our hygroscopicity testing services are designed to help clients accurately evaluate the moisture uptake behavior of drug substances, chemicals, and various other materials, even when internal resources or specialized expertise are limited. By delivering precise measurements, comprehensive data analysis, and actionable insights, we support clients in optimizing formulation, processing, packaging, and storage conditions. This ensures long-term product stability, consistent performance, and high quality, while minimizing risks associated with environmental moisture exposure.
BOC Sciences provides end-to-end hygroscopicity testing services designed to support pharmaceutical development, material science, and consumer product research. Leveraging our expertise in moisture behavior analysis, sample handling, and stability assessment, we deliver detailed insights into the water uptake and retention properties of APIs, excipients, formulations, and packaging materials. Our integrated approach ensures accurate, reproducible, and application-oriented data to guide formulation design, storage conditions, and quality control.
BOC Sciences evaluates the hygroscopicity of active pharmaceutical ingredients (APIs) under controlled humidity conditions, providing critical data on water absorption rates, equilibrium moisture content, and long-term stability. This service supports solid form selection, including salts, polymorphs, and co-crystals, identifying forms with optimal moisture tolerance. Accurate API moisture profiling enables risk mitigation for storage, handling, and formulation development.
We provide systematic analysis of pharmaceutical excipients such as lactose, microcrystalline cellulose, and starch to classify their hygroscopic behavior. By assessing moisture absorption rates, equilibrium water content, and environmental sensitivity, we deliver data that informs excipient selection and formulation design. This service also evaluates the impact of excipient moisture properties on flowability, compressibility, and potential for caking or agglomeration.
Our team conducts comprehensive hygroscopicity studies on drug formulations, including powders, granules, tablets, and inhalable dosage forms. We assess how moisture uptake affects physical integrity, dissolution performance, and product stability. These insights support accelerated stability testing, risk assessment, and optimization of storage and handling conditions for robust formulation development.
BOC Sciences examines the influence of formulation composition and excipient interactions on overall moisture behavior. By evaluating combinations of APIs, excipients, and additives, we provide actionable recommendations to minimize moisture sensitivity. Our analyses support formulation optimization, process parameter adjustments, and the design of moisture-stable drug products.
We offer testing and assessment of packaging materials to determine their effectiveness in controlling moisture ingress. This service includes evaluating barrier properties of bottles, blisters, sachets, and other packaging types, and correlating moisture protection performance with formulation stability. Data generated guides packaging selection and storage recommendations to enhance product shelf-life and quality.
BOC Sciences provides ongoing monitoring of moisture behavior across multiple batches of APIs, excipients, and formulations. We establish stability profiles to predict hygroscopic behavior under realistic storage conditions. This service supports quality control, supply chain risk management, and ensures consistency and reliability of moisture properties across production lots.
Powdered samples possess a large specific surface area, making them highly susceptible to environmental humidity. Hygroscopicity testing is used to evaluate stability during storage, transportation, and formulation processes, while guiding the selection of suitable packaging materials. Common methods include Dynamic Vapor Sorption (DVS) and constant temperature and humidity gravimetric analysis, which monitor weight changes under varying relative humidity to assess sorption rates and critical humidity points.
The hygroscopicity of crystalline materials is closely related to crystal form and lattice energy. Testing helps identify whether humidity triggers structural transitions or swelling, impacting stability and processability. Typical approaches combine DVS with X-ray Diffraction (XRD) to track both weight changes and humidity-induced phase transformations.
Tablets, containing multiple excipients and compressed structures, may lose hardness, alter disintegration profiles, or develop appearance defects upon moisture uptake. Results support formulation optimization and the selection of coatings and packaging. Testing is generally performed under constant temperature and humidity conditions with weight monitoring, complemented by hardness and disintegration time measurements.
Capsules may soften or become brittle due to shell hygroscopicity, while their contents may absorb moisture and affect dose stability. Testing evaluates the overall integrity and usability of the dosage form under humidity. The most common method is equilibration under constant humidity with gravimetric analysis, supplemented by appearance inspection and brittleness testing.
Granules, with relatively large surface areas, are prone to caking and reduced flowability when exposed to humidity. Testing informs drying conditions and packaging strategies to maintain uniformity and processability. Standard methods include gravimetric analysis under controlled humidity, often combined with angle of repose testing to assess flow properties.
Inhalation powders may agglomerate or cake under humid conditions, impairing aerosolization and dose accuracy. Hygroscopicity testing evaluates their performance reliability in storage and use. Common approaches integrate DVS sorption profiling with aerosol performance testing, assessing humidity effects on powder agglomeration and sprayability.
Lyophilized products, with porous structures, are highly sensitive to moisture uptake, which may cause collapse or degradation of active components. Hygroscopicity testing is critical for establishing stability and storage requirements. Typical methods include DVS monitoring and morphological analysis (e.g., microscopy or SEM) to assess water sorption and structural integrity.
Amorphous solids, being in a high-energy state, may recrystallize or undergo property changes upon moisture exposure. Testing supports risk evaluation and formulation design. Standard approaches employ DVS combined with Differential Scanning Calorimetry (DSC) to detect glass transition shifts and recrystallization tendencies.
Such a method is generally based on an analyzer of MCPC Moisture Computer and can be applied for a wide range of moisture measurements, such as major food products or the processing, some building materials, chemical compounds, and bio/pharmaceutical products.
TA represents one of the most efficient, reliable, and responsive methods for moisture determination. The primary principle of this methodology is to determine the weight loss of mass post-heating the materials being tested at a certain temperature.
Near-infrared spectroscopy estimates moisture content by analyzing specific absorption characteristics of water in the near-infrared range. This method is fast, non-contact, and can be applied for both offline and online monitoring, making it ideal for high-throughput quality control and in-process production monitoring.
This method generally involves a more responsive radiator in heating and cooling requirement cycles than the infrared heaters, which results in an accelerated responsiveness and saves the actual test cycle time. More importantly, when combining the thermogravimetric drying and halogen heating with highly accurate weighing technology, it can deliver a faster and more precise procedure for a wide array of moisture analysis.
This technique enables precise control of relative humidity (RH) while continuously monitoring the mass change of the sample. DVS allows the generation of detailed moisture sorption and desorption isotherms, providing both equilibrium and kinetic information. It is particularly suitable for powders, granules, tablets, and chemical/biopharmaceutical products, and can support raw material screening, formulation optimization, and storage condition assessment.
Coupling thermal analysis techniques such as TGA (thermogravimetric analysis) with DSC (Differential Scanning Calorimeter) or combining TGA with XRD (X-ray Diffraction) allows simultaneous evaluation of moisture changes and material structural transformations. This integrated approach provides insights into the impact of hygroscopicity on thermal stability and crystallinity, aiding in formulation optimization and long-term stability prediction.
Microwave or radio frequency enhanced moisture analysis rapidly evaporates water from the sample while performing precise weighing. This method accelerates the testing process and reduces cycle time, making it suitable for high-throughput laboratories and fast hygroscopicity assessments of pharmaceutical raw materials, food powders, and chemical granules.
We also provide clients with oven drying methods, which is commonly used for commercial purposes, such as substance vaporization, capacitance, Karl Fischer Titration, water activity, halogen, and infrared drying methods, and the thermogravimetric method of infrared drying technique.
Fig.1 Dynamic Vapor Sorption Measurement Setup3,4.
BOC Sciences' hygroscopicity analysis platform integrates a wide range of state-of-the-art instruments to perform thorough moisture behavior evaluations for APIs, excipients, formulations, and packaging materials. Our platform delivers accurate moisture measurements, dynamic sorption profiling, and stability assessments, providing dependable, reproducible, and actionable data to support pharmaceutical development, material research, and consumer product innovation.
Each client sample is carefully examined, and a tailored testing strategy is designed to meet specific sample characteristics and project objectives.
Samples are exposed to precise temperature and relative humidity conditions to realistically simulate storage, processing, and environmental scenarios.
Advanced techniques are employed to accurately quantify moisture absorption or loss, ensuring a comprehensive evaluation of hygroscopic properties.
Collected data are analyzed to generate key parameters, sorption profiles, and hygroscopicity classification, providing clear, actionable insights.
Clients receive a detailed report containing experimental results, graphical outputs, and expert recommendations for formulation, packaging, and storage optimization.
BOC Sciences is able to provide a full range of hygroscopicity testing for drugs, chemicals, and even materials, including solids, powders, or tissues. Additionally, with our advanced furnace control system, which has a great capacity for ramping the temperature from 25°C to 1100°C, any scale of your products can be tested at our laboratory. By determining whether the drug substance is sensitive to moisture, our scientists help you to make a decision for operational and procedural conditions that ensure the physicochemical stability and the pharmacological activity of your products.
Equipped with state-of-the-art instruments such as thermogravimetric analyzers, dynamic vapor sorption systems, and halogen/infrared dryers, we deliver highly accurate and reliable hygroscopicity measurements for a wide range of materials.
Our scientists design tailored testing strategies based on client sample types, project objectives, and specific requirements, ensuring results are meaningful and actionable.
Streamlined procedures and experienced staff allow us to provide timely testing without compromising data quality, supporting fast-paced product development timelines.
We provide detailed reports with quantitative results, graphical outputs, and professional recommendations to guide formulation optimization, packaging selection, and storage conditions, helping clients make informed decisions.
BOC Sciences delivers precise hygroscopicity testing to evaluate moisture absorption characteristics of materials. This insight supports stability optimization and packaging strategy development for enhanced product longevity. Our services provide actionable insights that guide formulation design, stability optimization, and packaging strategy development. By understanding moisture behavior, we help ensure product quality, consistency, and extended shelf-life across pharmaceutical, material, and consumer product applications.
The hygroscopicity test procedure generally involves exposing a material to controlled humidity conditions and monitoring the extent of moisture uptake over time. Commonly applied methods include gravimetric sorption analysis, TGA, halogen/infrared drying techniques, and Karl Fischer titration. Data such as equilibrium moisture content and sorption/desorption isotherms are collected to classify the material's sensitivity to atmospheric humidity and predict its storage and handling requirements.
In pharmacy, hygroscopicity refers to the tendency of a drug substance or dosage form to absorb moisture from its surrounding environment. This property is critical in pharmaceutical development because moisture uptake can cause changes in crystal structure, chemical degradation, reduced stability, altered dissolution behavior, or compromised bioavailability. Assessing hygroscopicity helps determine the optimal formulation, packaging, and storage conditions for ensuring product quality and shelf life.
According to the United States Pharmacopeia (USP), hygroscopicity is defined as the ability of a material to absorb moisture from the atmosphere under specified conditions of temperature and relative humidity. The USP further categorizes substances into different hygroscopicity classes (e.g., non-hygroscopic, slightly hygroscopic, hygroscopic, very hygroscopic, and deliquescent) based on the degree of water uptake, providing a standardized framework for evaluating and reporting this property in pharmaceutical substances.
The friability test for hygroscopic tablets is typically carried out using a rotating friabilator (e.g., Roche friabilator) by pre-weighing the tablets, rotating them at a specified speed (usually 25 rpm for 100 revolutions), then dedusting and reweighing to calculate the percentage weight loss. Since hygroscopic tablets readily absorb moisture, the test should be conducted under low-humidity conditions to avoid biased results, and any physical changes such as cracking, swelling, or sticking should also be noted.
To determine whether a salt is hygroscopic, the sample can be weighed and exposed to a controlled humidity environment for a set period, then monitored for weight gain or visible changes such as clumping or deliquescence. More precise methods include Dynamic Vapor Sorption (DVS), gravimetric sorption analysis, or thermogravimetric analysis (TGA), which quantify moisture uptake and classify salts as non-hygroscopic, slightly hygroscopic, hygroscopic, or deliquescent.
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