Moisture testing is viewed as one of the most fundamental quality parameters to ensure drug stability. Earlier this month, CD Formulation announces the release of moisture content determination service of active pharmaceutical ingredients (APIs) and inactive ingredients for researchers who are engaged with drug development and formulation.
Moisture determination is an important aspect of many industrial processes. In the manufacture of bulk solid pharmaceuticals, inappropriate moisture content can cause a wide range of safety and quality problems regarding compaction, powder flow, lubricity, chemical stability, crystal structure, dissolution rate, and polymer film permeability, etc. Therefore, moisture content determination has been made as a necessary step for quality control.
"With a strong scientific team of experts, we are able to provide a fast and accurate determination of moisture content. More importantly, our scientists will help clients to find the best and most favorable operational and procedural conditions, so that the physical and chemical stability and pharmacological activity of the product can be guaranteed," says the Marketing Chief of CD Formulation.
Moisture contained in dosage forms of drugs comes from sources like bulk drugs, inactive excipients or simply from manufacturing processes.
Several drying methods have been employed for moisture analyses, including 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, and exposing the sample to dry atmosphere (as in a desiccator).
In addition to drying methods, routine methods can also be used, covering methods with Near Infrared Reflectance (NIR) analyzer and method with Near Infrared Transmission (NIT) analyzer. Near-infrared spectroscopy (NIRS) is a particularly powerful determination method and has found application in the areas/products of granulation, lyophilization, capsules, etc.
Besides moisture content determination, CD Formulation also provides other drug analytical services like microbial limits test, bioavailability/bioequivalence detection, disintegration test, dosage units uniformity test, elemental impurities analysis, extractable & leachable test, particulate matter test for pharmaceutical companies. After the analytical project is completed, a full technical report will be delivered to customers. Visit: https://www.formulationbio.com/analytical.html to learn more details.
About CD Formulation
In the past decade, CD Formulation has made tremendous efforts to innovate drug formulation, trying to meet the increasing market demand for a more flexible and efficient drug development system. Although challenges and difficulties still exist, the company has successfully found a more intelligent approach to excipient design in the hope to address the long-standing issue of poor solubility and bioavailability of newer APIs. Equipped with a group of experienced staff, CD Formulation is working closely with the pharmaceutical industry as a contract service organization, offering outstanding expertise to handle complex drug formulation issues.