» Petrolatum Gauze is Absorbent Gauze saturated with White Petrolatum. The weight of the petrolatum in the gauze is not less than 70.0 percent and not more than 80.0 percent of the weight of petrolatum gauze. Petrolatum Gauze is sterile. It may be prepared by adding, under aseptic conditions, molten, sterile White Petrolatum to dry, sterile Absorbent Gauze, previously cut to size, in the ratio of 60 g of petrolatum to each 20 g of gauze.
Packaging and storage Each Petrolatum Gauze unit is so packaged individually that the sterility of the unit is maintained until the package is opened for use.
Labeling The package label bears a statement to the effect that the sterility of the Petrolatum Gauze cannot be guaranteed if the package bears evidence of damage or has been opened previously. The package label states the width, length, and type or thread count of the Gauze.
Sterility 71: meets the requirements.
Other tests The petrolatum recovered by draining in the Assay has the characteristics of and meets the requirements of the tests under White Petrolatum. The conditioned gauze obtained in the Assay meets the requirements of the tests for Thread count, Length, Width, and Weight under Absorbent Gauze.
Assay Weigh not less than 20 units of Petrolatum Gauze, place them in a heated glass funnel, maintaining the temperature at approximately 75, and allow the petrolatum to melt and drain from the funnel. Draining may be facilitated by pressing the gauze with a glass rod or porcelain spatula.
Wash the gauze on the funnel with successive portions of warm methyl chloroform until it is free from petrolatum, allow the residual methyl chloroform to evaporate spontaneously, condition the gauze in a standard atmosphere of 65 ± 2% relative humidity at 21 ± 1.1 for not less than 4 hours, and weigh. The difference between the weight of the gauze and that of the Petrolatum Gauze taken represents the weight of petrolatum.
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USP35NF30 Page 3321