Pharmacopeial specifications

Where there is a Ph Eur or national pharmacopeial specification for the excipient, this should be applied. Third country pharmacopeial specifications may also be acceptable. Routine tests and specifications should be stated. Function-related specifications should be included. 

Where there are existing pharmacopeial specifications for active ingredients in the Ph Eur or the pharmacopeia of a member state, these will be expected to apply. Other pharmacopeial specifications or in-house specifications may be used in other cases. The same is true for excipients where harmonized specifications are mentioned. Particular quality requirements related to a particular application are discussed, e.g., particle size control requirements. 

Humidity control The question of humidity control was examined in several ways. The moisture sorption isotherm showed moisture levels from 3-6% over a relative humidity range of 20-95%. Also, samples held at 65°C for over 2 weeks remained within this range of water content, which was within pharmacopeial specification. Finally, samples which were heated did not show a change in crystal form by X-ray powder diffraction, such as partial conversion to an anhydrate. Based on these results, humidity control was not deemed necessary for comparative stress studies. Samples to be compared were all stored under identical conditions, i.e., in the same oven. Any local change in humidity around each sample was therefore a function of the sample itself. 

Several types of materials are in use in the preparation of containers and closure systems glass, plastics, metals, and combinations of these materials. However, care should be taken in the selection of appropriate material. These materials should not present any physical or chemical reactivity that could modify drug activity, quality, purity, or physical characteristics of the drug and pharmaceutical preparations. Any minor modification in the pharmacopeial specification is acceptable if it does not present a threat to patient s health. 

On the face of it, the implication is that this sterilization specification/sterilizer parameters combination is invalid. However, remember that this same sterilization specification/sterilizer parameter combination would have been valid if the Bis used had D i-values of 1.5 min. In practical terms the pharmacopeial specification for thermal resistance in Bis has been set naively. Many companies purchasing spores of B. stearothermophilus, either for preparing Bis or as commercial strips, order against their own specifications which... 

Table I Pharmacopeial specifications for glacial acetic acid.

---