Moisture Analysis

The Importance of Moisture Analysis

Moisture analysis is critical to ensure the efficacy and stability of pharmaceuticals. Many properties of pharmaceutical products are affected by moisture content and directly affects how tablets are manufactured. These include chemical stability, crystal structure, compactability, powder flow, lubricity, dissolution rate and polymer membrane permeability. Excessive or insufficient moisture content can affect the chemical composition and physical properties of the drug, potentially reducing its effectiveness or causing premature degradation of the drug. In addition, drug products may contain compounds that are harmful on skin contact or inhalation, and moisture content is key to the crystallization, agglomeration and chemical form of these compounds during tablet manufacturing. Pharmaceutical companies can ensure that their products meet regulatory requirements and provide the expected therapeutic effects by conducting moisture analysis.

Moisture sources of formulations including:

• Bulk drug.
• Manufacturing processes.
• Environmental conditions.
• Excipients.

Explore Our Moisture Analysis Services

As the world's leading CMC analytical testing service provider, CD Formulation provides unparalleled moisture analysis services for customers' pharmaceuticals. Our analytical services cover moisture analysis of a variety of pharmaceutical products, including but not limited to powders, solid granules, tablets, capsules, topical ointments, oral solutions, etc.

Our Moisture Analysis Methods and Services Including:

• Gravimetric analysis

Gravimetric analysis for moisture analysiy by using the weight loss that occurs when a sample is heated to determine the moisture content, it is a complete, accurate and responsive moisture determination method based on the principle of drying. We offer the following drying methods for different solid pharmaceuticals:

• Infrared drying method: involves the use of an NIR (near-infrared reflectance) analyzer and the use of a NIT (near-infrared transmission) analyzer to determine moisture content.
• Oven-drying method: involves the determination of moisture content by exposing a sample to precisely defined drying environment (such as an oven).

• Karl Fischer moisture analysis

Karl Fischer moisture analysis is the most common method for determining the water content of most pharmaceutical products. When our scientists perform Karl Fischer moisture analysis, the sample is first weighed and placed into a glass container filled with desiccant. The sample container is then placed into a Karl Fischer moisture analyzer, which heats the sample to evaporate the water in the sample and then calculates the moisture content based on the change in weight of the sample. Our Karl Fischer moisture analysis can be performed on solids, liquids and even gases.

• For most solid dosage forms, we first dissolve the product in methanol for assay.
• For liquid formulations, we inject the sample directly into the instrument for analysis.
• For individual gas preparations, we perform analytical determinations using Karl Fischer devices specifically designed for analyzing gases.

• Laser headspace moisture analysis

In our laser headspace analysis, the sample is placed in a sealed headspace vial, then the sample is heated to evaporate it, and the vapor is carried to an optical system for detection. When the laser beam passes through the water molecules in the sample, absorption and scattering occur, and the water content is determined based on the intensity of the absorbed and scattered light.

Analyzable Dosage Forms

• Solid preparations.
• Liquid preparation.
• Gas preparation.

Why Choose CD Formulation for Moisture Analysis?

• Comprehensive evaluation of multiple moisture analysis methods can meet the needs of solid, liquid and gas sample analysis in any form, and provide accurate and consistent results.
• Flexible, tailor-made solutions that comply with international standards for moisture testing.
• Comprehensively understand the pharmacodynamic properties of raw materials, finished products and preparations to ensure that they meet specified standards and requirements.
• Extensive experience and expertise in moisture analysis to handle a variety of complex analytical challenges.
• A variety of analytical techniques and equipment for quantifying moisture content in various sample matrices.

CD Formulation has extensive experience and expertise in performing moisture analysis services. Our team of experienced scientists will work with you to develop a customized testing plan that meets your specific needs. Please contact us to learn more about how we can help you conduct moisture testing and verify the safety of your products to regulatory requirements.