Abstract

Saponification value is defined as mg KOH needed to neutralize free acids and saponify esters in 1 g of the test substance. A search of the literature showed that the standard saponification methods of the U.S. Pharmacopeia, alcoholic potassium hydroxide were the only saponification reagent. The sample to investigate is saponified with an excess of ethanolic potassium hydroxide solution. After finished saponification the remaining excess of potassium hydroxide is determined by residual titration under Titrimetry , with aqueous volumetric hydrochloric acid. In this study, a test for saponification value has been successfully determined in carnuba wax. The average result has been found 90.9 mg KOH/g substance and, % RPD was 1.65%. This is in contradistinction to the U.S. Pharmacopeia/National Formulary (USP/ NF) Method.

Highlights

  • The word wax comes from the Old English weax meaning “material of the honeycomb” carnuba wax

  • A test for saponification value has been successfully determined in carnuba wax

  • The average result has been found 90.9 mg KOH/g substance and, % RPD was 1.65%. This is in contradistinction to the U.S Pharmacopeia/National Formulary (USP/ NF) Method

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Summary

Introduction

The word wax comes from the Old English weax meaning “material of the honeycomb” carnuba wax. Carnuba Wax consists of myricyl cerotate and small quantities of free cerotic acid and myricyl alcohol. A major component of carnuba wax coating on the leaves of Brazilian Palm and formula is CH3(CH2)30COO(CH2)23CH3 [3]. A test for saponification value has been successfully determined in carnuba wax. This is in contradistinction to the U.S Pharmacopeia/National Formulary (USP/NF) Method. Carnuba wax is used in the pharmaceutical industry for tablet coatings and binding. Carnuba wax is the hardest and highest-melting of the waxes commonly used in pharmaceutical formulations and is used primarily as a 10% w/v aqueous emulsion to polish sugar-coated tablets. Aqueous emulsions may be prepared by mixing carnuba wax with an ethanolamine compound and oleic acid. Carnuba wax (10% - 50% w/w) is used alone or with other excipients such as hypromellose, hydroxypropyl cellulose, alginate/pectin-gelatin, Eudragit, and stearyl alcohol to produce sustained-release solid-dosage formulations [8]-[15]

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