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Analysis of Biopharmaceutical Lyophilizate Residual Moisture by Loss on drying (LOD) Method (CAT#: STEM-B-0415-CJ)

Introduction

The development of a lyophilized formulation and the corresponding freeze-drying process go hand in hand. An in-depth characterization of the freeze-dried powder during process development provides all relevant data require to optimize critical process parameters. Freeze-drying has advanced to the point where it is a common practice for biopharmaceuticals, including blood plasma and vaccines. Lyophilization is still a method of choice for preservation of the growing list of biopharmaceutical products.




Principle

Dry weightlessness (LOD) is the simplest and oldest residual moisture analysis technique and can be performed without any specialized laboratory equipment. Remove the sample from the vial and weigh it into a dry container. Dry the sample using heat, vacuum or desiccant to remove moisture, then cool and reweigh. The moisture content is calculated by dividing the weight lost during drying by the original weight. While this method is simple, it lacks the accuracy and specificity required for most applications. Dry weight loss test only obtained the amount of weight loss, not specific to water.

Applications

Biopharmaceutica

Procedure

1. Remove the sample from the vial and weigh it into a dry container. 2. Dry the sample using heat, vacuum or desiccant to remove moisture, then cool and reweigh.
3. Calculate the moisture content by dividing the weight lost during drying by the original weight .

Materials

• Sample: Proteins, Peptides, Nucleic acids, Naturally-occurring compounds & more

Notes

• Other volatiles in the product (e.g., ethanol) may also be repelled, producing inaccurate results.
• Sample degradation may occur at higher temperatures, which may lead to erroneous high results, especially for proteins.
• ncomplete sample drying may produce erroneous low results.
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