REFERENCE FORMULA
Reference formula
Reference basis: 40 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Phenobarbital sodium powder | 400 mg | — |
| Glycerol | 4 mL | — |
| Water meeting source specification | q.s. ad 40 mL | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-NZ-007 · Phenobarbital sodium 10 mg/mL oral solution
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Clear colourless solution. [1]
Action and use
Barbiturate antiepileptic/sedative.
Active-drug context from another product’s labelling; it does not establish stability or dosing of this compounded preparation. [2]
Active-drug context from another product’s labelling; it does not establish stability or dosing of this compounded preparation. [2]
Specifications
Clear and colourless. Reject if yellowing or precipitation occurs. [1]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
Glycerol is miscible with water. This does not establish product microbiological stability. [3]
Humidity
Glycerol is hygroscopic; limit raw-material exposure to moisture. [3]
Temperature
For the finished product the source specifies:
Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk. [1]
Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk. [1]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
Glycerol: hazardous reaction with strong oxidising agents. [3]
Ingredient-specific information
Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [3], [5]
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [3], [5]
Staff protection
Risk assessment
Reference batch: 40 mL. First ingredient: Phenobarbital sodium powder, 400 mg. Independently check chemical form, units and every scale conversion before weighing.
Check complete dissolution and crystallisation at the selected temperature. Calculate dose volume from the exact mg/mL, not the starting tablet or stock strength. Supply a suitable oral syringe.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. [1], [9], [11]
Check complete dissolution and crystallisation at the selected temperature. Calculate dose volume from the exact mg/mL, not the starting tablet or stock strength. Supply a suitable oral syringe.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. [1], [9], [11]
Compounding conditions
BUD rationale
Period reported by source: 7 days, as revised on 11 February 2025.
Use the source’s specific short period and temperature. Do not transfer the general refrigerated 14-day limit to room temperature.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [7], [8], [10], [12]
Use the source’s specific short period and temperature. Do not transfer the general refrigerated 14-day limit to room temperature.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [7], [8], [10], [12]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
Weigh sodium salt, wet with glycerol and add water progressively. Transfer quantitatively, make to 40 mL, mix and package. [1]
Observations
Use phenobarbital sodium powder, not phenobarbital free acid or tablets. Water must meet the source therapeutic-use specification and applicable local quality requirements. [1]
Container and packaging
Amber plastic bottle as specified by the sheet. [1]
Quality control
Clear and colourless. Reject if yellowing or precipitation occurs.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [5], [11]
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [5], [11]
Storage
Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk. [1]
Dispensing
Do not refrigerate. Do not use if yellow colour or precipitate develops. Use powdered sodium salt. [1]
Labelling
Phenobarbital sodium 10 mg/mL oral solution
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk.
Temperature for this batch BUD: ____ [1]
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Amber plastic bottle, ≤25 °C. Do not refrigerate: precipitation risk.
Temperature for this batch BUD: ____ [1]
v9_controls
The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- New Zealand Compounding Working Group — NZ standardised oral formulation batch sheet; hosted by PSNZ4.0 / 11/02/2025PDF pp. 1–2master formula2026-09-10
- DailyMed / NLM: PHENOBARBITAL TABLET [REMEDYREPACK INC.]SPL published Sep 03, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- FN/2003/PA/013 GLICEROLΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023, revision 1Recommendations; section on pharmacy compoundingraw material quality2026-09-12
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14