Release Control and Quality Requirements

A simple visual control is sufficient to determine on homogeneity of the mass, and whether lumps or agglomerates are present or not. Filled capsules should be free of dust and well closed after preparation. Moreover, they should not be dented. A dent may lead to a too low dose delivered to patients. 

The average weight is used to check whether the right capsule size has been used and to get an impression of the loss of powder mixture. The average weight is determined on ten capsules (see Sect. 32.7.1). It is advised to sample selectively by taking the capsules from the centre and the comers of the capsule filler. If the amount of powder mixture is insufficient to fill all the capsules, the ones in the comers usually will not be filled completely. 

The uniformity of mass is expressed as the relative standard deviation and is determined by dividing the standard deviation of the weight of the filled capsules by the average weight of the content. The Ph. Eur. (see Sect. 32.7.1) asks 

From experience can be stated that a batch will meet the Ph. Eur. requirements when weighing ten capsules and calculating the average weight and standard deviation for capsules containing less than 300 mg, the relative standard deviation should be below 4 %. For capsules containing more than 300 mg, the relative standard deviation should be below 3 %. 

The average weight and the uniformity of mass are indicators for the weight distribution of the powder over the capsules. The weight distribution depends on the flowability of the powder, the completeness of filUng and the operator s precision. However, it does not give information on the active substance content per capsule. Due to mixing variation there will never be a perfect content uniformity. 

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Preparation processes (or steps or unit operations) are treated as well as in-process controls, release control and quality requirements. 

Preparation, Release Control and Quality Requirements of Enemas. 222... 

Method of preparation, release control and quality requirements of sterile vaginal solutions are the same as for irrigation solutions (Preparations for irrigation Ph. Eur., see Sect. 14.7). Preparation method and release controls of non-sterile vaginal solutions are the same as for solutions for cutaneous use (see Sect. 12.6.5). 

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