Reference basis: 110 g αρχική σύνθεση / 110 g reference charge
Ingredient
Source quantity
Scaled quantity
Glycerol
90 g
—
Wheat starch
10 g
—
Purified water
10 g
—
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
Soft, greasy-feeling, translucent gelatinous mass of wheat starch, glycerol and water. Charges total 110 g; the formula is not q.s. ad 100 g and water must not be silently removed to change the batch basis. [1], [2], [3]
Action and use
The source describes a protective/emollient cutaneous preparation for eczema and scaling, particularly of the hands. Apply as needed within individual care; it contains no corticosteroid or antimicrobial active. [1], [2], [3]
Specifications
Use wheat starch RFE 0359 and glycerol RFE 0496; finished appearance should be a homogeneous translucent gel. No formula-specific viscosity, pH or microbiological acceptance limit is given. Check for lumps and scorching. [1], [2], [3], [5]
Light
The source does not specify special light protection. Keep in the approved closed container away from direct sunlight that could raise temperature above 25 °C; photostability is not claimed. [1]
Air and oxidation
Close after cooling/filling and after every use. Water loss/uptake and contamination can alter the surface; the master does not require an inert atmosphere. [1], [3], [4], [5]
Water and solubility
The 10 g water charge initially disperses the starch. Starch is practically insoluble in cold water; heating develops the gel. Do not add water after heating to compensate losses without an approved process, because the source provides no such q.s. instruction. [1], [2]
Humidity
Glycerol is hygroscopic. The source requires protection from moisture and preparation-room relative humidity ≤60%. Avoid prolonged open exposure of raw glycerol and finished gel. [1], [3], [4], [5]
Temperature
Preheat glycerol to the source-specified 90 °C and continue controlled heating until homogeneous/translucent. Prevent hot spots: thermal decomposition of glycerol can produce irritating acrolein. Store the product below 25 °C. [1], [4]
pH and compatibility
No final pH or buffer is specified. The general gels procedure includes pH as a possible batch check but gives no acceptance range for this gel. Any selected pH test needs a documented local method. [1], [5]
Other interactions
Do not contact glycerol with strong oxidisers, particularly potassium permanganate, because of fire/violent-reaction risk. Adding alcohol, essential oils or drugs creates a different formula requiring separate evidence. [3], [4]
Ingredient-specific information
The starch is from wheat, Triticum aestivum (syn. T. vulgare), and must not be arbitrarily replaced with maize starch. Use the pharmaceutical glycerol of the cited monograph, not a prediluted 85% solution. All quantities are in grams. [1], [2], [3]
Staff protection
Use gloves, coat and eye protection during weighing/mixing and contain starch dust. The 90 °C stages require a stable vessel, heat-resistant handling aids and splash protection. Use controlled electric heating without an open flame and adequate ventilation. [1], [4], [5]
Risk assessment
Main process risks are burns, overheating/scorching, nonuniform dispersion and contamination after cooling. Declare wheat starch and check allergy history. The source coeliac warning concerns accidental ingestion of potentially gluten-containing material; it does not establish the same reaction from skin exposure. [1], [2], [4]
Compounding conditions
On the 110 g input basis, glycerol is 90/110=81.82% and starch/water each 10/110=9.09%. These calculations are not an assay of final yield after heating. Record temperature, time, appearance and mass loss without uncontrolled topping up. [1], [5]
BUD rationale
The source specifies one week, below 25 °C and protected from moisture. Use a ceiling of 7 days under these conditions, shortened by ingredient or quality limits. No exact-formula study or measured aw was found; the high glycerol proportion does not justify extension to 90 or 180 days. [1], [6]
Prerequisites
Dependencies are the gels procedure, identified wheat starch and a locally documented heating process. The different French 86.8/6.6/6.6 g per 100 g formula is not interchangeable. [1], [2], [5]
Equipment
Balance, heat-resistant vessel, controlled electric hotplate, suitable thermometer, robust spatula/stirrer and clean tube or jar. Equipment must permit continuous wall scraping to reduce local overheating. [1], [4], [5]
Compounding method
1. Disperse 10 g starch in the 10 g water without lumps. 2. Preheat the 90 g glycerol to 90 °C and add to the dispersion. 3. Heat with continuous stirring to a homogeneous translucent mass using controlled electric heat, avoiding caramelisation/scorching. 4. Continue stirring to room temperature, check and package. Record the local temperature profile. [1], [4], [5]
Observations
This mixture has a 110 g input mass. Water loss during heating changes composition and cannot be hidden by simply relabelling as 100 g. Do not transfer its use period to bases with different starch or glycerol proportions. [1], [5]
Container and packaging
Use a tube or jar as specified, tightly closed and protected from moisture. A tube reduces repeated hand contact with the bulk but does not constitute microbiological validation. [1], [5]
Quality control
Check uniformity, translucency, soft gelatinous consistency, absence of lumps/scorched spots and final mass. For batches, the general procedure includes applicable spreadability, pH and microbiological tests. Do not enter invented results or viscosity limits. [1], [5]
Storage
Keep tightly closed, protected from moisture and below 25 °C, for no more than 7 days. Do not reuse remnants of a previous batch or add water if consistency changes. [1], [5]
Dispensing
Use on clean skin with a clean applicator as directed. Declare wheat starch, prevent swallowing and obtain clinical advice before breast application during lactation. Dispense quantities compatible with the 7-day limit. [1], [2]
Labelling
Glycerol–wheat starch cutaneous gel. Contains WHEAT starch. Cutaneous use only — do not swallow. Store below 25 °C, tightly closed, protected from moisture. Maximum 7 days from preparation. Complete quantity, batch and actual dates during execution. [1], [2]
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.
Sources and references
AEMPS, Formulario Nacional — GLICEROLADO DE ALMIDÓN (FN/2003/PO/016)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
AEMPS — Almidón de trigo (FN/2003/PA/004)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
AEMPS — Glicerol (FN/2003/PA/013)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
ILO/WHO International Chemical Safety Card 0624 — GlycerolApril 2006Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
AEMPS — Elaboración de geles (PN/L/FF/003/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
USP — Compounding Standards and Beyond-Use DatesNovember 2022 update, official USP fact sheet hosted by Mississippi Board of PharmacyNonsterile preparation BUD overview and category tableGeneral BUD framework; an AEMPS source period is not automatically a USP–NF monograph exception, and no measured water activity is implied.2026-10-13
USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14
