The safety and effectiveness of drugs cannot be separated from their properties. Moisture content is an essential control index of drugs, widely recorded by pharmacopoeia in various countries. A certain amount of moisture can increase the stability of the drug. Water content is closely related to microbial growth and biochemical reactions. Reasonable moisture content can avoid degradation of active ingredients during storage. Therefore, the moisture content of samples and RLD needs to be highly concerned during the development of generic drugs. In general, the moisture requirements of self-manufactured products should be consistent with RLD, and can also be appropriately shrunk.
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Moisture content can affect the quality and shelf life of drugs. Moreover, drug content calculations require moisture data. The development of generic drugs often requires the evaluation of the moisture content of raw materials, intermediates and finished products.
Our company has a professional moisture test platform and technical personnel to provide accurate, repeatable moisture test method development services for drugs. After receiving moisture determination requirements from our customers, we develop suitable moisture determination methods based on the physical and chemical properties of the drug.
Moisture determination methods include the Karl Fischer method, drying method, vacuum drying method, toluene method, and gas chromatography. The state and composition of the sample, as well as the form of moisture present, will affect moisture determination. Our company's moisture content analysis method is based on the Karl Fischer method commonly used in chemical drugs.
The Karl Fischer determination method determines the moisture content by using a Karl Fischer reagent that reacts quantitatively and selectively with water. This method has the advantages of simple operation, high efficiency and high accuracy. The Karl Fischer moisture determination method is especially suitable for samples that are easily destroyed by heat, and can measure not only free water but also bound water.
Our Moisture Determination Method Development Process
Composition and prescription analysis
After we receive samples from customers, the first step is to analyze the sample for solubility, moisture induction, stability, and for any components that may have side reactions with Karl Fischer's reagent.
The choice of the main method
The principle of Karl Fischer's method is iodine measurement, which is divided into volumetric method and Coulomb method. The biggest difference between the two methods is that the source of iodine is different. The iodine in the volumetric method is from the titration reagent, while the iodine in the Coulomb method is produced by electrolysis of the electrolyte containing iodine ions.
The moisture detection range of the volumetric method is 1%-100%, which has high working efficiency and high accuracy. For drugs containing trace amounts of water and with high moisture requirements, the Coulomb method is usually preferred. It can detect moisture in the range of 0.001%-0.1%. The Coulomb method has both high detection speed and data parallelism.
Titrant selection
A variety of titrants are available, including one-component pyridine titrants, two-component pyridine titrants, aldehyde-ketone specific titrants, and anodic titrants.
Solvent selection
Our choice of solvents is non-aqueous methanol, anhydrous ethanol, and anhydrous methanol-formamide/DMF.
Instrument parameter development
According to the characteristics of your sample, we can adjust and screen the parameters of the moisture measuring instrument.
- Rotational speed
- Drift value
- Initial drift value
- Drift correction
- Extraction time
Validation of the method
We can provide a complete validation process for moisture detection methods. We deliver the method after confirming its system suitability, specificity, precision, and accuracy.
Our Advantages
- Customized service
- Advanced test platform
- Rich method development experience
- Accurate, traceable test results
