Sterile Products in Pharmacy

<p>0.576°C (B)</p> Signup and view all the answers

<p>0.28°C (B)</p> Signup and view all the answers

<p>Water for Injection USP/BP (C)</p> Signup and view all the answers

<p>Color (A)</p> Signup and view all the answers

<p>Benzyl alcohol (D)</p> Signup and view all the answers

<p>0.9% w/v (D)</p> Signup and view all the answers

<p>Distillation or Ion Exchange (C)</p> Signup and view all the answers

<p>It has the same osmotic pressure as body fluids. (A)</p> Signup and view all the answers

<p>Number of solute particles. (D)</p> Signup and view all the answers

<p>Freezing point depression method. (B)</p> Signup and view all the answers

<p>Osmoles per kg of solvent. (B)</p> Signup and view all the answers

<p>285-295 mOsm/L (B)</p> Signup and view all the answers

<p>They shrink. (D)</p> Signup and view all the answers

<p>Freezing point depression. (D)</p> Signup and view all the answers

<p>Increased osmotic pressure. (A)</p> Signup and view all the answers

<p>Freezing the product, Primary drying, Secondary drying (A)</p> Signup and view all the answers

<p>They must be stored at low temperatures for stability. (C)</p> Signup and view all the answers

<p>Solute bound water (C)</p> Signup and view all the answers

<p>They aid in chemical and/or physical stabilization. (C)</p> Signup and view all the answers

<p>They are entirely seated in the vials. (C)</p> Signup and view all the answers

<p>24 to 72 hours (A)</p> Signup and view all the answers

<p>Sterile crystallization followed by aseptic filling (B)</p> Signup and view all the answers

<p>0.1135°C (A)</p> Signup and view all the answers

<p>80.47 mg (B)</p> Signup and view all the answers

<p>2.0 %w/v (B)</p> Signup and view all the answers

<p>6.6 g (A)</p> Signup and view all the answers

<p>The freezing point depression of the drug solution (A)</p> Signup and view all the answers

<p>0.5760°C (A)</p> Signup and view all the answers

<p>330 mL (C)</p> Signup and view all the answers

<p>W = (0.52 - a) / b (D)</p> Signup and view all the answers

<p>Water for Injections BP (B)</p> Signup and view all the answers

<p>To prevent cell lysis during administration (B)</p> Signup and view all the answers

<p>0.101˚C (D)</p> Signup and view all the answers

<p>0.02 g (D)</p> Signup and view all the answers

<p>Freezing point depression of the unadjusted solution (B)</p> Signup and view all the answers

<p>0.576 °C (D)</p> Signup and view all the answers

<p>0.80 %w/v (D)</p> Signup and view all the answers

<p>0.507 °C (C)</p> Signup and view all the answers

<p>0.80 g (C)</p> Signup and view all the answers

<p>To maintain appropriate osmotic pressure (D)</p> Signup and view all the answers

<p>Weight/volume percentage of the adjusting substance (D)</p> Signup and view all the answers

<p>0.338 °C (A)</p> Signup and view all the answers

A solution with the same osmotic pressure as a body fluid. Important for ophthalmic, nasal, and parenteral solutions.

A solution with a higher osmotic pressure than a body fluid. Can cause red blood cells to shrink.

A property that depends solely on the number of particles in a solution, not their size or weight.

A measure of the osmotic pressure of a solution. Expressed in osmoles per liter (Osmol/L).

A measure of the osmotic pressure of a solution. Expressed in osmoles per kilogram of solvent (Osmol/kg).

A method used to determine the freezing point of a solution, which can be used to calculate the amount of solute needed to make a solution isotonic.

The freezing point depression method is used to determine the amount of substance to add to a hypotonic solution to make it isotonic.

Calculations using the freezing point depression method to determine the amount of solute needed to make a solution isotonic.

The change in freezing point of a solution compared to the pure solvent. It's directly proportional to the molality of the solute.

The freezing point depression value of a 1 %w/v solution of a specific substance. It's a measure of the substance's impact on the freezing point of the solution.

The amount of a substance needed to adjust a hypotonic solution to isotonic. It's calculated using the fpds and the desired osmolality.

A formula used to calculate the amount of adjusting substance needed to make a hypotonic solution isotonic. The formula considers the fpds of both the drug and the adjusting substance.

The weight/volume percentage of adjusting substance needed to make a hypotonic solution isotonic is given by this equation: W = (0.52 - a) / b

Where: W = weight/volume percentage of adjusting substance in the final solution a = freezing point depression of the unadjusted solution b = freezing point depression of water due to 1% w/v of adjusting substance (usually sodium chloride or glucose)

The freezing point depression of a 1% w/v solution of the substance

The freezing point depression of a 1% w/v solution of the adjusting substance used to make the final solution isotonic

The concentration of a solution expressed as grams of solute per 100 mL of solution

A process that involves removing water from a frozen product by sublimation, a direct transition from solid to gas.

The temperature below which a solution freezes and forms a solid crystalline structure.

The temperature at which an amorphous material transitions from a solid state to a glassy state.

The process of removing water molecules that are bound to the dissolved substances within a freeze-dried product.

Substances added to freeze-dried formulations to increase the volume of the final product.

A sterile method used to manufacture antibiotics by crystallizing the active ingredient and filling it into sterile containers.

A common type of vial that holds sterile powders, often used for antibiotics.

A common antimicrobial preservative frequently used in bacteriostatic water for injection.

Water for injection (WFI) prepared by distillation or reverse osmosis, free of pyrogens and used for non-sterile applications.

A solvent system consisting mainly of water used in injectable products.

The pressure exerted by a solution due to the difference in solute concentration across a semipermeable membrane.

Important attributes of injectable products that affect their safety and effectiveness.