Finished dosage form, parenterals

To modify processing properties for the manufacture of finished dosage forms (tablets, capsules, parenterals, etc.)... 

Purified drug substances are mixed with excipients into finished dosage forms sohds, liquids, parenterals, inhalants, and ointments and creams, then packaged and labeled and shipped for distribution. 

Microbial limit tests, as described in USP 24-NF 19 (<61>) provide the information necessary to conduct bioburden counts by quantitative estimations of viable aerobic microorganisms in pharmaceutical articles, raw materials, and finished dosage forms. Consult the EP or JP for any differences in these methods from those of the USP. Note that USP (<61>) is currently under revision and that the next version will be fully harmonized between the USP, EP, and JP. The microbial limit test comprises the total aerobic bacterial (microbial) count (TAG), the total combined yeasts and molds count (TYMC), and tests for indicator organisms. Bioburden tests are also referred to as total viable counts. This test estimates the total number of viable (culturable) aerobic microorganisms in various items including parenteral UBPS. The total viable count is obtained by adding the counts from the TAC and the TYMC. 

Largevolume Parenterais. Sterile solutions for parenteral application with a volume of 100 ml or more in one container of the finished dosage form. 

Although bacterial endotoxins are of microbiological origin, they are not lost with loss of viability. Of the sterilization processes commonly used in the manufacture of sterile parenteral dosage forms (see above), only dry heat is capable of destroying bacterial endotoxins in a reasonable time frame. There is therefore no practical way of removing bacterial endotoxins from finished drug products thus, they must be controlled at source. 

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