REFERENCE FORMULA
Reference formula
Reference basis: 100 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Baclofen 20 mg tablets | 50 δισκία / tablets | — |
| Ora-Blend vehicle | q.s. ad 100 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-CA-001 · Baclofen 10 mg/mL oral suspension
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
Oral suspension of the listed composition. The IWK sheet does not specify colour/odour/viscosity. [1]
Action and use
Antispasticity agent.
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
No numerical QC criteria are given. Define local homogeneity, redispersibility and release criteria. [1]
Light
For the finished product the source specifies:
Amber plastic bottle, protected from light. Refrigerate or room temperature. No numerical temperature range stated. [1]
Amber plastic bottle, protected from light. Refrigerate or room temperature. No numerical temperature range stated. [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
Baclofen: JP classifies the corresponding pure raw material as slightly soluble in water. [4]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [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
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Baclofen: raw-material water solubility is classified as slightly soluble by JP. [4]
Staff protection
Risk assessment
Reference batch: 100 mL. First ingredient: Baclofen 20 mg tablets, 50 δισκία / tablets. Independently check chemical form, units and every scale conversion before weighing.
Redispersibility is critical: homogenise before subdivision, check for hard sediment and verify that the graduated oral syringe delivers the required volume without blockage/air. Clarity is not an acceptance criterion for a suspension.
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: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [9], [11]
Redispersibility is critical: homogenise before subdivision, check for hard sediment and verify that the graduated oral syringe delivers the required volume without blockage/air. Clarity is not an acceptance criterion for a suspension.
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: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. [1], [9], [11]
Compounding conditions
BUD rationale
Period reported by source: Source states 60-day stability under those conditions.
Primary study of the same active/strength: 60-day chemical stability in different specified vehicles at 5/25 °C. It does not automatically establish Ora-Blend equivalence or microbiological extension.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
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], [6], [7], [8], [10], [12]
Primary study of the same active/strength: 60-day chemical stability in different specified vehicles at 5/25 °C. It does not automatically establish Ora-Blend equivalence or microbiological extension.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
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], [6], [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
Pulverise tablets. Levigate with about 10 mL vehicle, dilute progressively, transfer to a graduate and make to final volume. Mix and package. [1]
Observations
IWK sheet 13/06/2017; public index reports NAPRA review. Stated stability is not an approved local BUD. Retain the exact vehicle and assess supporting evidence. [1]
Container and packaging
Amber plastic bottle. [1]
Quality control
No numerical QC criteria are given. Define local homogeneity, redispersibility and release criteria.
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], [11]
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], [11]
Storage
Amber plastic bottle, protected from light. Refrigerate or room temperature. No numerical temperature range stated. [1]
Dispensing
Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. [1]
Labelling
Baclofen 10 mg/mL oral suspension
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Amber plastic bottle, protected from light. Refrigerate or room temperature. No numerical temperature range stated.
Shake/redisperse well before use.
Temperature for this batch BUD: ____ [1]
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Amber plastic bottle, protected from light. Refrigerate or room temperature. No numerical temperature range stated.
Shake/redisperse well before use.
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
- IWK Health — Pharmacy, institutional compounding formula13/06/2017PDF pp. 1master formula2026-09-10
- DailyMed / NLM: BACLOFEN TABLET [REMEDYREPACK INC.]SPL published Sep 07, 2026Indications / warnings / pharmacologyclinical class only2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: BaclofenJP XVIII, 2021; English textPrinted p. 510; Description; Containers and storageraw-material monograph2026-09-12
- 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
- Allen LV Jr, Erickson MA III. Stability of baclofen, captopril, diltiazem hydrochloride, dipyridamole, and flecainide acetate in extemporaneously compounded oral liquidsPrimary study; abstract readAm J Health Syst Pharm. 1996;53:2179–2184; DOI 10.1093/ajhp/53.18.2179Abstract only; chemical/physical evidence; applicability is appraised in the BUD field2026-09-12
- 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