Orleans Community Pharmacy

Compounding QC Tools

NAPRA · USP 795

Step 1 — Enter capsule weights (g)

Cap 1

Cap 2

Cap 3

Cap 4

Cap 5

Step 2 — Acceptable variation limit

± % of mean Default: 10% per NAPRA non-sterile guidelines

Preparation details

Preparation / compounding date

Defaults to today

Earliest ingredient expiry (optional)

Leave blank if unknown

Preparation category (USP 795)

Non-preserved aqueous dosage form

14 days · Aqueous (aw > 0.6), no antimicrobial preservative — e.g. plain solutions, eye drops

Preserved aqueous dosage form

35 days · Aqueous (aw > 0.6) with antimicrobial preservative — e.g. oral solutions, suspensions, preserved topicals

Nonaqueous dosage form

90 days · Low water activity (aw ≤ 0.6) — e.g. ointments, creams, suppositories, oral nonaqueous liquids

Solid dosage form

180 days · Capsules, tablets, lozenges, troches, powders — no free water

Storage conditions

Note: BUD limits are the same for room temp and refrigerated — storage does not extend the BUD beyond USP 795 defaults

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