REFERENCE FORMULA
Reference formula
Reference basis: 100 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Sucrose | 85 g | — |
| Purified water | 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-BR-016 · Simple syrup 85% w/v — FNFB
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
Hypertonic sucrose syrup 85% w/v, close to saturation. [1]
Action and use
Sweetening vehicle for oral liquids. [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:
Amber glass, protected from light, room temperature. [1]
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
Sucrose: JP classifies the corresponding pure raw material as very soluble in water. [3]
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
Sucrose: raw-material water solubility is classified as very soluble by JP. [3]
Staff protection
Risk assessment
Reference batch: 100 mL. First ingredient: Sucrose, 85 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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], [7], [9]
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
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], [7], [9]
Compounding conditions
BUD rationale
This implementation is limited to a freshly prepared intermediate in the same continuous compounding operation. Prepare only the necessary quantity, cool and make to volume as the procedure specifies, incorporate without planned storage, and discard the remainder. Record preparation, incorporation and disposal times. No stock dating or release for a later operation is assigned. Stored-stock use remains a separate, unresolved application. [1], [10]
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
Dissolve sucrose in 50 mL water with stirring in a water bath not exceeding 80 °C. Cool, make to volume, mix and filter. [1]
Observations
This national formula specifies 85 g to 100 mL and a heated process. It is not merged with syrups of different composition or process.
Stored syrup needs exact sucrose/water evidence: final mass fraction, density, crystallisation, aw and microbiological behaviour including relevant yeasts. The designation 85% w/v does not establish aw <0.60. Do not transfer dating from a differently formulated preserved syrup.
This implementation is limited to a freshly prepared intermediate in the same continuous compounding operation. Prepare only the necessary quantity, cool and make to volume as the procedure specifies, incorporate without planned storage, and discard the remainder. Record preparation, incorporation and disposal times. No stock dating or release for a later operation is assigned. Stored-stock use remains a separate, unresolved application. [1], [9], [10]
Stored syrup needs exact sucrose/water evidence: final mass fraction, density, crystallisation, aw and microbiological behaviour including relevant yeasts. The designation 85% w/v does not establish aw <0.60. Do not transfer dating from a differently formulated preserved syrup.
This implementation is limited to a freshly prepared intermediate in the same continuous compounding operation. Prepare only the necessary quantity, cool and make to volume as the procedure specifies, incorporate without planned storage, and discard the remainder. Record preparation, incorporation and disposal times. No stock dating or release for a later operation is assigned. Stored-stock use remains a separate, unresolved application. [1], [9], [10]
Container and packaging
Amber glass, protected from light, room temperature. [1]
Quality control
Visually inspect appearance; check final volume/mass and, for suspensions, redispersion. No specific validated analytical method for the finished mixture was located in the source. These proposed in-process checks do not replace assay or microbiological testing when required.
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], [9]
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], [9]
Storage
Dispensing
Labelling
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
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)2012, 2nd ed., Rev. 02 — supersededPDF pp. 196master formula2026-09-10
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: SucroseJP XVIII, 2021; English textPrinted p. 1748; 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
- 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