Special Handling
Certain classes of Pharmacopeial articles may require special handling. Such articles include products classified as dangerous goods under the Department of Transportation (DOT), state, local, or carrier rules or products classified as controlled substances by the Drug Enforcement Administration (DEA) or by individual states. Upon arrival of Pharmacopeial articles to warehouse loading docks, premises, and other arrival areas, the Pharmacopeial articles are to be transferred to their...
Aerodynamic Size Distribution
Cascade impaction devices classify aerosol particles and droplets on the basis of those particles' aerodynamic diameters. The principle of their operation, whereby they separate aerosol particles and droplets from a moving airstream on the basis of particle or droplet inertia, is shown in Figure 3. Fig. 3. Schematic representation of the principle of operation of cascade impactors. (A single jet per impactor stage is shown. Impactors with multiple jets in each stage function in the same Fig. 3....
Topical Aerosols
The following tests are applicable to topical aerosols containing drug, in suspension or solution, packaged under pressure, and released upon activation of an appropriate valve system. Perform these tests only on containers fitted with continuous valves. Delivery Rate Select not fewer than four aerosol containers, shake, if the label includes this directive, remove the caps and covers, and actuate each valve for 2 to 3 seconds. Weigh each container accurately, and immerse in a...
Measures Of Powder Compressibility
The Compressibility Index and Hausner Ratio are measures of the propensity of a powder to be compressed. As such, they are measures of the relative importance of interparticulate interactions. In a free-flowing powder, such interactions are generally less significant, and the bulk and tapped densities will be closer in value. For poorer flowing materials, there are frequently greater interparticle interactions, and a greater difference between the bulk and tapped densities will be observed....
Ultraviolet Visible Infrared Atomic Absorption Fluorescence Turbidimetry Nephelometry And Raman Measurement
Absorption spectrophotometry is the measurement of an interaction between electromagnetic radiation and the molecules, or atoms, of a chemical substance. Techniques frequently employed in pharmaceutical analysis include UV, visible, IR, and atomic absorption spectroscopy. Spectrophotometry measurement in the visible region was formerly referred to as colorimetry however, it is more precise to use the term colorimetry only when considering human perception of color. Fluorescence...
Strength And Total Volume For Single And Multipledose Injectable Drug Products
For single-dose and multiple-dose injectable drug products, the strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per mL enclosed by parentheses. For containers holding a volume of less than 1 mL, the strength per fraction of a mL should be the only expression of strength. Strength per single mL should be expressed as mg mL, not mg 1 mL. The following formats are acceptable for contents...
Monographs And General Chapters
Monographs set forth the article's name, definition, specification, and other requirements related to packaging, storage, and labeling. The specification consists of tests, procedures, and acceptance criteria that help ensure the identity, strength, quality, and purity of the article. For general requirements relating to specific monograph sections, see section 5, Monograph Components. Because monographs may not provide standards for all relevant characteristics, some official substances may...
Bioidentity Test
Proceed as directed for Rabbit Blood Sugar Method Quantitative with the following modifications Procedure Divide the rabbits into four equal groups of two rabbits each. Calculation Proceed as directed for Calculation under Rabbit Blood Sugar Method Quantitative, but do not determine the confidence interval of the log-relative potency, Interpretation If the potency value obtained is not less than 15 USP Units per mg, the Bioidentity Test requirement is met. If the potency value is less than 15...
Bs
Veterinary Medicine Information (VMI) Jennifer L. Buur, D.V.M., Ph.D. Terrence P. Clark, D.V.M., Ph.D. Devin Wade Elias Ronette Gehring, B.V.Sc., MMedVet, MRCVS Dinah G. Jordan, Pharm.D. Vernon Cory C. Langston, D.V.M., Ph.D. Katrina L. Mealey, D.V.M., Ph.D. Mark G. Papich, D.V.M., M.S. M. Gatz Riddell, D.V.M., Ph.D. Information Expert Committees (2005-2010) Model Guidelines Expert Committee (MGEC) Darrell R. Abernethy, M.D., Ph.D., Chair Nancy Jo Braden, M.D. Mitchell F. Brin, M.D. Barbara A....
Distribution And Shipment Of Pharmacopeial Articles
As indicated in Figure 1, a drug can take a variety of paths from the manufacturer to the patient. In the simplest form of the distribution system, the manufacturer ships directly to the customer, such as a doctor's office, clinic, or hospital. However, more often, the article leaves the manufacturer's chain of control and enters a complex system of handoffs that involve the distribution chain to the patient. Figure 1. Drug product distribution. Figure 1. Drug product distribution. Shippers and...
