Master formulation and compounding records

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Preparation nameStrengthDosage formRouteChapterBatch size

Ingredients

Library

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: 91 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: Methadone oral solution 10 mg/mL

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

Ingredients

Ingredient	Role	Quantity
Methadone hydrochloride	active	1 g
Methylparaben and propylparaben (optional)	preservative
Aqueous vehicle (see the study)	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: Amber glass bottles (closed and in daily use) · Storage: Refrigerator · BUD: 91 days

Basis: Duration supported by the cited stability study for this formula, container, and storage. Álvaro-Alonso EA et al. Molecules. 2022;27(9):2812. PMC9105510

Labeling

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

References

Álvaro-Alonso EA, Lorenzo MP, Gonzalez-Prieto A, Izquierdo-García E, Escobar-Rodríguez I, Aguilar-Ros A. Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mL. Molecules. 2022;27(9):2812. PMC9105510. https://pmc.ncbi.nlm.nih.gov/articles/PMC9105510/

Notes

Formulations with and without parabens performed the same.

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.