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: 90 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.

A nonpreserved aqueous CNSP must be stored in a refrigerator for this BUD.

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: Clonidine oral suspension 20 mcg/mL

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

Ingredients

Ingredient	Role	Quantity
Clonidine hydrochloride	active	2 mg
Ora-Blend	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 plastic bottles · Storage: Controlled room temperature · BUD: 90 days

Basis: Duration supported by the cited stability study for this formula, container, and storage. Coache D et al. PLoS One. 2021;16(11):e0260279. PMC8631633

Labeling

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

References

Coache D, Friciu M, Roullin VG, Boulé M, Forest JM, Leclair G. Stability evaluation of compounded clonidine hydrochloride oral liquids based on a solid-phase extraction HPLC-UV method. PLoS One. 2021;16(11):e0260279. PMC8631633. https://pmc.ncbi.nlm.nih.gov/articles/PMC8631633/

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.