Master formulation and compounding records

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Preparation nameStrengthDosage formRouteChapterBatch size

Ingredients

Library

NIOSH Table 2

Scale batch tomL

Ingredient chips: FDA 503A categories and lists, 21 CFR 216.24, and NIOSH hazardous drugs. Check an ingredient in detail, including FDA shortages.

Equipment

Compounding steps

Quality control

Container and packagingStorage

Beyond-use date

Current: 60 days · Duration supported by the cited stability study for this formula, container, and storage.

Work out the BUD

Preparation

Nonsterile (USP <795>)Sterile (USP <797>)

Dosage form

Aqueous (water-containing)Nonaqueous oral liquidOther nonaqueous (capsules, powders, suppositories, anhydrous ointments)

Contains a preservative (preserved aqueous)

Water activity (optional)0.60 or higher is aqueousUSP–NF monograph BUD (optional)Only when following the monograph exactly

Storage

Controlled room temperatureRefrigerator

Compounding date (optional)Earliest component expiration (optional)

Apply a stability study for this preparation

Beyond-use date

14 days

Refrigerator

Nonpreserved aqueous dosage form: 14 days, refrigerated.

USP <795> §10.4 (CNSPs requiring shorter BUDs), Table 4 (BUD limits by type of preparation)

Rules current as of the USP <795> and <797> revisions official November 1, 2023. Verify against the current official USP chapter before assigning a BUD.

Labeling

References

Notes

Master formulation record: Phenytoin oral suspension 5 mg/mL

Oral suspension · Oral · Nonsterile (USP <795>) · Batch 100 mL

Ingredients

Ingredient	Role	Quantity
Phenytoin	active	500 mg
SyrSpend SF PH4 Dry, reconstituted	vehicle	q.s.

Equipment

Class A prescription balance or electronic balance
Mortar and pestle
Graduated cylinder

Quality control

Visual inspection: uniform appearance, no foreign matter
Final volume or weight checked

Packaging, storage, and BUD

Container: See the study · Storage: Refrigerator · BUD: 60 days

Basis: Duration supported by the cited stability study for this formula, container, and storage. Binson G et al. Pharmaceutics. 2019;11(4):190. PMC6523203

Labeling

Shake well. Store as directed. Discard after the beyond-use date.

References

Binson G, Beuzit K, Migeot V, et al.. Preparation and Physicochemical Stability of Liquid Oral Dosage Forms Free of Potentially Harmful Excipient Designed for Pediatric Patients. Pharmaceutics. 2019;11(4):190. PMC6523203. https://pmc.ncbi.nlm.nih.gov/articles/PMC6523203/

Notes

Free of potentially harmful excipients for neonates.

Prepared by

Approved by

Date

Record contents follow the master formulation and compounding record sections of USP <795> and <797>; check your state board's requirements. For licensed clinicians. Use with clinical judgment.