Cellacefate Analysis Service
Unlock the Potential of Cellacefate with Precision Analysis
Cellacefate is an organic synthetic material that appears as white or off-white amorphous fibrous, fine strips, flakes, granules, or powder. Cellacefate has good thermal stability and weatherability, and is a common pharmaceutical excipient, for example, used as a coating material and release blocker, etc.
CD BioGlyco utilizes first-class Pharmaceutical Analysis technology to conduct research on Pharmaceutical Excipients and provide high-quality cellacefate analysis services to our clients.
- Identification
The infrared spectrogram of the sample is tested and the resulting profile is compared with the infrared profile of the cellacefate standard. If the two profiles agree, the sample is cellacefate.
- Solubility
Cellacefate is insoluble in water and ethanol and dissolves in acetone to a clear or slightly turbid colloidal solution.
- Viscosity
After dissolving the cellacefate sample in a mixture of acetone and water, we check its viscosity using a viscometer. The viscosity of cellacefate should be in the range of 45 to 90 mPa·s.
- Moisture content
A mixture of anhydrous ethanol and dichloromethane is used as a solvent to fully dissolve the cellacefate and the moisture content is checked by hydrometry. It should be noted that the water content of cellacefate should not exceed 5.0%.
- Free acid content
First, the cellacefate sample is fully dissolved in a methanol solution. Next, it is titrated using a sodium hydroxide solution with phenolphthalein as an indicator. Finally, the free acid content in cellacefate is calculated based on the amount of titrant used.
- Heavy metal content
The amount of heavy metals contained in cellacefate is tested based on the incineration residue and must not exceed 10 parts per million of the total mass of cellacefate.
- Cellacefate content
Cellacefate is fully dissolved in an organic solvent, then titrated using phenolphthalein as the acid-base indicator and a specific base solution as the titrant, the results of which are corrected with a blank test. The amount of formyl benzoate in cellacefate is calculated based on the amount of alkali solution used, the moisture content of cellacefate, and the amount of free acid.
- Acetyl content
After dissolving cellacefate in a specific alkaline solution, a phenolphthalein indicator solution is added. Next, it is titrated with hydrochloric acid as a titrant. In the end, the amount of titrant used is used to calculate the acetyl group content of cellacefate.
- Cauterization residue
The residue of cellacefate after sufficient cauterization not exceeding 0.1%.
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Publication Data
Technology: Electron microscope
Journal: Pharmaceutics
IF: 5.4
Published: 2022
Results: In this research, the authors tested the activity of the capsules in different dispersions. The authors used a two-step pH change to simulate passage through the digestive tract and evaluated the capsules by electron microscopy, disintegration, and dissolution experiments, and found that the capsules coated with cellacefate had good acid resistance. Moreover, regardless of polymer concentration, capsules coated with 15.0% and 20.0% cellacefate release their contents at pH 7.5 in 435 and 495 minutes, respectively.
Fig.1 Scanning electron micrograph of a capsule coated with cellacefate. (Fülöpová, et al., 2022)
Frequently Asked Questions
- What is cellacefate?
Cellacefate is the reaction product of phthalic anhydride and cellulose meta-acetate, which is also known as cellulose acetate phthalate (CAP). It contains not less than 21.5% and not more than 26.0% acetyl (C2H3O) and not less than 30.0% and not more than 36.0% phthaloyl (C8H5O3) groups, calculated as anhydrous acid. Cellacefate is a commonly used excipient in pharmaceutical formulations. It is used in the enteric coating of tablets or capsules as well as in controlled-release formulations. It protects tablets from being dissolved by stomach acid but dissolves in the alkaline region of the duodenum, thus protecting the stomach from ulcers or allowing better absorption of the drug in the duodenum.
- Is cellacefate soluble in water? Which solvents does it dissolve in?
Cellacefate is insoluble in water. This is because cellacefate is produced by controlled esterification of the pure raw material cellulose with acetic acid and acetic anhydride. In this process, acetyl groups replace all or part of the hydroxyl units on the cellulose chain, reducing the water solubility of cellacefate.
In contrast, cellacefate is soluble in acetone, dioxane, and dilute solutions of bases.
Advantages
- Our Pharmaceutical and Biological Analysis Service applies to a wide range of industries, including life science research, pharmaceutical research, and agricultural science research.
- Our service team is composed of biological scientists, proficient in the characterization of physical and chemical properties of cellacefate, and biological activity analysis techniques, to provide clients with a high level of cellacefate analysis services.
- Each of our cellacefate analysis protocols undergoes rigorous quality testing to ensure data stability and reliability.
CD BioGlyco is dedicated to in-depth research in the field of biology, providing our clients with best-in-class solutions in pharmaceutical and biological research. We help you perform comprehensive cellacefate analysis and accelerate your research process. Please feel free to contact us if you need quality and courteous service.
Reference
- Fülöpová, N.; et al. Development and comparison of various coated hard capsules suitable for enteric administration to small patient cohorts. Pharmaceutics. 2022, 14: 1577.
This service is for Research Use Only, not intended for any clinical use.