Moisture Content Determination
The presence of moisture will affect the chemical and physical properties of the final product. Excessive moisture can cause the powder particles to agglomerate and make the tablets brittle. Too little moisture can cause tablets to scatter. Powdered excipients may not flow if they are too wet, and some active pharmaceutical ingredients (API) may crystallize or change form if there is too much moisture. The production method of solid dosage form includes freeze-drying, fluidized bed drying, compaction, granulation and extrusion. All of these operations depend on the amount of moisture present and the state, moisture also affects the chemical/physical properties of individual active ingredients and excipients. Therefore, accurate determination of moisture content is very important to ensure the quality of drugs.
Fig.1 Common types of contact drying equipment.
CD Formulation can provide you with moisture content determination services of APIs and inactive ingredients, and our scientists will help you to make a decision for operational and procedural conditions that can ensure the physical and chemical stability and pharmacological activity of the product to minimize potential formulation and stability issues.
Moisture Sources of Dosage Forms
- Bulk drug
- Manufacturing processes
- Inactive excipients
- Environmental conditions
Our Methods for Moisture Content Determination
| Methods | |
| Drying methods | Direct determination |
| Absorption of water in a suitable drying agent (desiccant is measured before and after absorption) | |
| Indirect determination - mass loss of the sample | |
| Drying of the samples under precisely defined conditions -, methods in an oven method | |
| Exposing the sample to dry atmosphere (as in a desiccator) | |
| Routine methods | Method with NIR (Near Infrared Reflectance) analyzer |
| Method with NIT (Near Infrared Transmission) analyzer | |
Deliverable
- Data analysis
- Provide full study report
Our Advantages
If you have a requirement about moisture content determination services, please contact us by phone or email, our colleagues will reply to you within three working days.
References
- Mainali D, Li J, Yehl P, et al. Development of a Comprehensive Near Infrared Spectroscopy Calibration Model for Rapid Measurements of Moisture Content in Multiple Pharmaceutical Products[J]. Journal of Pharmaceutical and Biomedical Analysis, 2014, 95: 169-175.
- Marjanović-Balaban Ž, Jelić D, Antunović V, et al. Determination of Water content in Pharmaceutical Substances[J]. Journal of Hygienic Engineering and Design, 2013.
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