Nonsterile Preparations - NAPLEX

USP <1163>. USP <1163> focuses on quality assurance programs, including process validation and stability testing for compounded preparations.

USP <795>. USP <795> outlines standards for personnel, facilities, documentation, and quality assurance in nonsterile compounding.

A compounded preparation not required to be sterile. Nonsterile preparations are compounded drugs intended for routes where sterility is not necessary, such as oral or topical use.

Nonsterile compounding (not a CSP). USP categorizes preparations not requiring sterility as nonsterile compounding, distinct from CSPs which must be sterile under <797>.

Compounding components. Compounding components are official USP-NF substances or approved ingredients ensuring quality and safety in preparations.

Quantity sufficient to make the final volume or weight. QS indicates adding enough vehicle to reach the desired total volume or weight for accurate concentration.

Standardized recipe and instructions for a compounded preparation. An MFR ensures consistency by detailing ingredients, equipment, procedures, and expected yield for repeated compounding.

Document the actual ingredients, steps, and results for that batch. A CR records specifics of each compounding event to verify compliance, traceability, and quality for that preparation.

Beyond-use date (BUD). BUD indicates the date after which the preparation should not be used, based on stability and microbial risk.

Not later than $6$ months or earliest ingredient expiration, whichever is earlier. For nonaqueous formulations, USP <795> sets this BUD to limit degradation while considering ingredient stability.

Not later than $14$ days when stored at $2$–$8,^{\circ}\text{C}$. Refrigeration slows microbial growth in water-containing orals, justifying the 14-day BUD per USP <795>.

Not later than $30$ days. Topical water-containing preparations have higher microbial risk, so USP <795> limits BUD to 30 days at room temperature.

$20$–$25,^{\circ}\text{C}$ with permitted excursions per USP. USP defines this range to maintain stability, allowing brief excursions to 15–30°C for real-world conditions.

Oral liquid (solution or suspension). Oral liquids allow dose adjustment and ease of administration for patients with swallowing difficulties.

Dissolve drug directly in vehicle, then QS to final volume. Direct dissolution ensures uniform distribution when the drug dissolves easily without additional steps.

Levigate with a suitable agent, then incorporate vehicle gradually. Levigation creates a smooth paste to suspend insoluble particles evenly before adding the vehicle.

Reduce particle size and improve dispersion by forming a paste. Levigation minimizes agglomeration and ensures homogeneous mixing in semisolid or liquid preparations.

Levigate with a mineral oil or other oil-miscible agent. Oil-miscible agents like mineral oil ensure compatibility and even dispersion in hydrophobic bases.

Geometric dilution. Geometric dilution progressively mixes equal volumes to achieve uniform distribution of potent substances.

$%,w/v=\frac{\text{g solute}}{\text{mL solution}}\times 100$. This formula expresses concentration as grams of solute per 100 mL of solution for liquid preparations.

$%,w/w=\frac{\text{g solute}}{\text{g preparation}}\times 100$. This formula calculates weight-based concentration for solids or semisolids using total preparation weight.

$20,\text{mg/mL}$. 2% w/v means 2 g per 100 mL, equivalent to 20 mg per mL by unit conversion.

$6,\text{mL}$. Divide dose by concentration to find volume: $150 / 25 = 6$ mL for accurate administration.

Nonaqueous preparation: BUD not later than $6$ months. Anhydrous ointments lack water, reducing microbial risk, so USP <795> allows up to 6 months at room temperature.