Final editorial decision
Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution.
Required evidence
- Identified master-formula revision, hydroxide grade and potency basis, actual-lot CoAs, final container/closure and dosing device.
- Approved exact-matrix development report: actual pH, suitable content and acid-neutralisation-capacity methods, withdrawal uniformity, sedimentation/redispersibility, microbial quality and preservation evidence.
- Actual duration study in final packaging at the claimed temperature. Any proposed refrigeration requires separate physical and dose-delivery suitability at 2–8 °C.
Closure criteria
- Applicable monograph specifications, methods and per-test limits are approved before the study. Water activity is not used as a substitute for stability or preservation.
- All required criteria are met through the proposed period, using a suitable microbial method and documented review of deviations.
- A signed final report supports a defined period, package and temperature. The responsible pharmacist separately approves the actual batch.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- ANVISA Formulário Nacional, 2nd edition, revision 02 (2012), historical editionPrinted pp.84–86 / PDF pp.84–862026-10-14
- EMA Questions and answers on benzoic acid and benzoates used as excipientsOfficial indexed extract: activity in acidic conditions, pH 2.5–4.52026-10-14
- ANVISA Formulário Nacional catalogueCurrent third-edition catalogue; not an exact-formula study2026-10-14
REFERENCE FORMULA
Reference formula
Reference basis: 100 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Aluminium hydroxide | 6 g | — |
| Sodium saccharin | 10 mg | — |
| Sodium benzoate | 0.525 g | — |
| High-viscosity sodium carmellose | 1 g | — |
| Glycerol | 2.5 mL | — |
| Flavour | q.s. — | — |
| Purified water | q.s. ad 100 mL | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Oral suspension: Aluminium hydroxide 6% w/v suspension. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Antacid. [1]
Specifications
Composition and final quantity follow the formula table (100 mL). The reviewed specific text gives no numerical assay, microbial-count or physicochemical acceptance range; no unsupported limit is assigned. [1]
Light
For the finished product the source specifies:
Well-closed opaque plastic or amber glass, protected from light, room temperature. [1]
Well-closed opaque plastic or amber glass, protected from light, room temperature. [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
Humidity
Glycerol is hygroscopic; limit raw-material exposure to moisture. [2]
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
Benzoic acid/benzoate preservation is described by EMA in acidic conditions, pH 2.5–4.5. Preservation at higher pH must not be assumed. [4]
Other interactions
Glycerol: hazardous reaction with strong oxidising agents. [2]
Ingredient-specific information
Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Sodium Benzoate: raw-material water solubility is classified as freely soluble by JP.
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. [2], [5], [6]
Sodium Benzoate: raw-material water solubility is classified as freely soluble by JP.
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. [2], [5], [6]
Staff protection
Risk assessment
Benzoic acid/benzoates may worsen neonatal jaundice through bilirubin displacement. Assess use in neonates up to 4 weeks; topical exposure can also irritate.
Reference batch: 100 mL. First ingredient: Aluminium hydroxide, 6 g. 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], [4], [10], [12]
Reference batch: 100 mL. First ingredient: Aluminium hydroxide, 6 g. 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], [4], [10], [12]
Compounding conditions
BUD rationale
Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution. [1], [4], [14]
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
Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution. [1], [4], [14]
Observations
Shake before use. Qualify high-viscosity carmellose grade. No numerical redispersion or assay criteria specified.
For the exact alkaline matrix study pH, acid-neutralising capacity, settling/redispersibility, syringe-delivered dose and microbiology. Sodium benzoate presence does not establish effective preservation at alkaline pH. Refrigeration requires evidence of physical compatibility before using the 14-day default. [1], [12]
For the exact alkaline matrix study pH, acid-neutralising capacity, settling/redispersibility, syringe-delivered dose and microbiology. Sodium benzoate presence does not establish effective preservation at alkaline pH. Refrigeration requires evidence of physical compatibility before using the 14-day default. [1], [12]
Container and packaging
Well-closed opaque plastic or amber glass, protected from light, room temperature. [1]
Quality control
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. [6], [12]
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. [6], [12]
Storage
Source-reported conditions/container: Well-closed opaque plastic or amber glass, protected from light, room temperature.
The source specifies room temperature/15–25 °C. The general 14-day rule requires 2–8 °C and does not apply under the source conditions. No numerical batch BUD is assigned until compatible refrigerated storage or a specific period under the source conditions is supported. [1], [8], [9]
The source specifies room temperature/15–25 °C. The general 14-day rule requires 2–8 °C and does not apply under the source conditions. No numerical batch BUD is assigned until compatible refrigerated storage or a specific period under the source conditions is supported. [1], [8], [9]
Dispensing
final_decision
Final historical development reference. Preserve the ANVISA 2012 formulation and its provenance. The individual entry specifies room-temperature storage without a numerical period. Sodium benzoate in the ingredient list does not establish adequate preservation in the final antacid matrix. No BUD, batch calculator or dispensing label is issued. Refrigeration or arbitrary acidification changes the evaluated conditions or formulation function and is not adopted as a literature-based solution. [1], [4], [14]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 84master formula2026-09-10
- 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
- EMA — Questions and answers on benzoic acid and benzoates, EMA/CHMP/508189/20139 October 2017Preservative pH and neonatal safetyingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Sodium BenzoateJP XVIII, 2021; English textPrinted p. 1698; Description; Containers and storageraw-material monograph2026-09-12
- 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
- ANVISA Formulário Nacional catalogueCurrent third-edition catalogue; not an exact-formula studyTargeted prerequisite / publication decision; not batch result2026-10-14