USP Guidelines

Sterile and Nonsterile Compounding

<797> Sterile Compounding – Provides extensive and specific information and guidelines for preparation and testing of sterile formulations.

<795> Nonsterile Compounding - Provides extensive and specific information and guidelines for preparation and testing of nonsterile formulations.

<85> Bacterial Endotoxin Test – Describes the testing requirements to determine level of endotoxins in sterile preparations as required in <797>.

<71> Sterility Tests – Describes testing requirements for aerobes, anaerobes, and fungi as required in <797> and requirements for Method Suitability testing.  Also states the quantities needed for testing based upon batch sizes.

<51> Antimicrobial Effectiveness Testing – Provides testing procedures to determine the effectiveness of antimicrobial agents in sterile and nonsterile formulations by challenging them with large quantities of designated microbes.

Potency Testing

<1225> Validation – Defines the analytical performance characteristics desired to determine the reliability and accuracy of the testing method used to assess the pharmaceutical article. These analytical performance characteristics include accuracy, precision, specificity, linearity and range, limit of detection, and limit of quantitation.

<857> Ultraviolet-Visible Spectroscopy – Describes the use of absorbance of light in the UV-Vis region of the spectrum to quantify the amount of a substance in a solution.  To some degree, it can also be used to help identify substances.  As a practical matter, these solutions must be simple, typically containing only one ingredient.

<831> Refractive Index - (Potency Management to create)

<736> Mass Spectrometry – Provides information about the use of this technique, which is based upon molecular weight, to identify and quantify ingredients.  This instrument is normally coupled with chromatography <621> to separate and quantify ingredients.   It is very sensitive, able to quantify very low microgram amounts, and useful for very complex formulations.

<621> Chromatography – Provides information and guidelines for analysis of ingredients by means of this powerful separation technique.  This is the most common technique for analysis of potency and stability of pharmaceutical preparations.

<541> Titration - (Potency Management to write)

Specialty Testing

<1207.2> Package Integrity Leak Test Technologies, (Container Closure), 3.4 Tracer Liquid Test – Describes the use of a tracer liquid to provide an indication of a package leak.

<921>  Water Determination, Method 1a - Details the method to determine both adsorbed water or water of hydration (such as monohydrate or hexahydrate) in a sample by a titration technique commonly referred to as Karl-Fischer direct titration.

<854>  Mid-Infrared Spectroscopy – Describes the use of infrared “finger print” spectra to help identify molecular structure.  Many USP monographs specify infrared (FT-IR) as the primary means of determining drug identity.

<791> pH – Describes technique for the determination of pH of formulations.  This test is useful for stability of a preparation as well as comfort where high or low pH could be detrimental or irritating.

<788>, <789> Particulate Matter in Injections and Ophthalmics – Describes the testing techniques used to determine if injectable or ophthalmic preparations meet requirements for maximum allowable numbers of particles in the 10µm, 25µm, and 50µm range.

<731> Loss on Drying – Provides procedure for determining amount of volatile substances in a sample.  This could include residual solvents, water, or other volatiles.

<730> ICP-OES - (Potency Management to create)

<381> Elastomeric Closures for Injections, Self-Sealing Capacity – Describes characteristics and test procedures for elastomeric vial and syringe closures, and provides test protocol to determine their ability to prevent intrusion through the seal.