Glycerinated alcohol —50 g glycerol plus 50 mL hydroalcoholic vehicle 2 · CGR-ES-103 (CGR-ES-103)

REFERENCE FORMULA

Reference formula

Reference basis: Παρτίδα εισροών 50 g+50 mL· πραγματική απόδοση καταγράφεται / component batch 50 g+50 mL; actual yield recorded

Ingredient	Source quantity	Scaled quantity
Glycerol	50 g	—
Hydroalcoholic vehicle 2, FN/2003/EX/027 / CGR-ES-059	50 mL	—

Prerequisite formulations

CGR-ES-059 · Hydroalcoholic vehicle 2 EX027

Documentation

Preparation description

Clear colourless liquid from 50 g glycerol and 50 mL of a specific hydroalcoholic vehicle. This is a component batch with different units. It is not asserted to yield 100 g or 100 mL, or an exact alcohol percentage without measured yield/density. ^[1]

Action and use

Historical AEMPS skin preparation listing prevention of pressure lesions/nipple fissures [1]. These uses are not adopted as current evidence-based recommendations: NICE advises against preventive massage of pressure areas [5], and nipple pain requires feeding/cause assessment [6]. Use only following a specific clinical decision. ^{[1], [5], [6]}

Specifications

Source: clear colourless liquid. Exact final mass/volume, ethanol strength, pH and aw are not supplied. Record actual yield and uniformity; do not impose “100 g” as the release criterion for a 50 g+50 mL batch. ^{[1], [2], [7]}

Light

Use an amber bottle as specified. Retain protection without asserting a particular photodegradation rate. Do not substitute an open application vessel. ^[1]

Air and oxidation

Volatile ethanol requires limited open time; do not deliberately evaporate it to make a “milder” product. Tight closure protects composition. Provide ventilation and remove ignition sources during transfer [3]. ^{[1], [2], [3]}

Water and solubility

Water enters throughEX 027. Do not add water to force an arbitrary 100 mL final volume. Glycerol and ethanol content alone are not an aw measurement or proof of antiseptic efficacy. ^{[1], [2]}

Humidity

No finished-product humidity limit is specified. Closed material containers and prompt accurate glycerol weighing limit composition changes. Avoid water introduced by wet equipment. ^{[1], [7]}

Temperature

Below 30 °C as specified. Mix without heating; ethanol dilution may transiently alter temperature/volume, so allow equilibration before yield measurement. Keep away from hot surfaces, flames and sparks [3]. ^{[1], [2], [3]}

pH and compatibility

No pH specification is supplied. If pH is monitored, the ethanol/glycerol matrix requires a suitable analytical method. Do not add buffer/neutraliser or invent an acceptance range. ^{[1], [7]}

Other interactions

This is neither WHO hand-rub nor equivalent to an alcohol antiseptic of specified strength. Segregate ethanol raw material from strong oxidants [3]. Do not add fragrances/other APIs that alter tolerability or composition. ^{[1], [2], [3]}

Ingredient-specific information

Use glycerolRFE 0496 with verified identity and DEG/EG controls [4]. Vehicle 2 is prepared from 70 mL 96% ethanol plus 30 mL purified water [2]. Input volumes do not prove 100 mL final vehicle because of contraction; measure 50 mL of the actual homogeneous prepared vehicle. ^{[1], [2], [4]}

Staff protection

Use material-compatible gloves, eye protection during mixing and laboratory clothing. Ventilation, safe ethanol storage and exclusion of ignition sources are critical [3]. Remove slippery glycerol spills by controlled cleaning. ^{[3], [7]}

Risk assessment

Risks include treatingg/mL as interchangeable, volatile-loss changes in alcohol strength, DEG/EG in glycerol, raw-material ignition and irritation of damaged skin [1,3,4]. Avoid nipple application with possible infant exposure without specific review. The historical pressure-lesion claim does not replace pressure/position assessment [5,6]. ^{[1], [3], [4], [5], [6]}

Compounding conditions

Scale by batch factor k:50 k g glycerol+50 k mL vehicle 2. Record actual final mass/volume after equilibration, without q.s. to 100 units. Verify the correct vehicle batch and non-denatured ethanol. ^{[1], [2], [7]}

BUD rationale

Source:3 months below 30 °C in an amber bottle [1]. No matching primary study for this 50 g+50 mL component batch was identified. Use only a reference ceiling of 89 days and≤3 calendar months with local documentation of exact vehicle, yield, container and controls. Unknown aw/final alcohol strength do not establish “self-preservation”. Earlier vehicle/glycerol expiry prevails; clinical suitability is assessed separately. Editorial convention: calendar-month source periods are retained as calendar periods; the calendar-period conversion ceiling is 28 days for one month or 89 days for three months; a separately selected shorter ceiling still governs. It is a conservative conversion, not a source quotation. ^{[1], [2], [7]}

Prerequisites

CGR-ES-059 / FN/2003/EX/027 hydroalcoholic vehicle 2. It is not vehicle 1 CGR-ES-058. Check stock composition, batch, yield and closure before measuring 50 mL. ^{[1], [2]}

Equipment

Balance for 50 g glycerol, volumetric measure for 50 mL vehicle, compatible covered mixing vessel, stirrer and amber bottle. Equipment must permit actual-yield measurement without uncontrolled evaporation. ^{[1], [2], [7]}

Compounding method

1. Prepare/check vehicle 2 from the exact ethanol/water charges. 2. Weigh 50 g glycerol. 3. Measure 50 mL homogeneous vehicle and add progressively to glycerol with mixing. 4. Allow equilibration, inspect clarity and record yield. 5. Package in amber glass and close promptly. ^{[1], [2], [7]}

Observations

The method preserves actual component charges.50 g+50 mL is not “50% glycerol” without a defined basis and measurement. Do not infer 67.2% ethanol for the finished glycerinated product from the intermediate vehicle charges. ^{[1], [2]}

Container and packaging

Use an amber tight bottle suitable for hydroalcoholic liquid. Avoid an open jar/spray presentation without separate assessment. Label actual supplied quantity and external use. ^{[1], [2], [7]}

Quality control

Verify glycerol identity/DEG-EG controls, vehicle batch,g/mL charges, clarity and actual yield. If final ethanol percentage is claimed, use an appropriate analytical/density method for the ternary system, not an alcoholmeter without demonstrated suitability. ^{[1], [2], [4], [7]}

Storage

Below 30 °C in a tightly closed amber bottle. Keep away from heat/ignition sources and children. Do not assign neat ethanol’s measured flash point to the finished mixture. ^{[1], [2], [3]}

Dispensing

Supply only after specific clinical assessment of the intended application. Do not routinely recommend for pressure-ulcer prevention or nipple fissures. Avoid ingestion, eyes and irritated skin. Explain that it is not a validated hand antiseptic. ^{[1], [5], [6]}

Labelling

Glycerinated alcohol — EXTERNAL USE. Component formula 50 g glycerol+50 mL vehicle 2. Actual quantity: __. Approved application/directions: __. Below 30 °C, tightly closed, away from ignition sources and children. Do not swallow. Batch: __. Prepared: __. Use by: __. compounding.gr. ^{[1], [2], [3], [7]}

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: ALCOHOL GLICERINADOFN/2006/PO/036; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
AEMPS — FN/2003/EX/027 Solución hidroalcohólica 2Current standalone sourcePDFp.2 composition/methodVehicle component charges 70 mL ethanol 96% plus 30 mL water; no final-volume top-up specified2026-10-13
ILO/WHO — ICSC0044 Ethanol (anhydrous)May 2018Fire/explosion; handling; chemical incompatibilitiesRaw ethanol hazards; numerical anhydrous flash point is not assigned to finished mixtures2026-10-13
FDA — DEG/EG testing of high-risk components including glycerinMay 2023 Revision 1SectionsI andIVGlycerol raw-material identity, supply-chain and DEG/EG controls; not a Greek statutory requirement2026-10-13
NICE — CG179 Pressure ulcers: prevention and managementCurrent official indexed recommendations retrieved 2026-10-13Adult and paediatric recommendations on skin massage; official indexed search text retrieved, full-page fetch blockedDo not offer skin massage/rubbing for pressure-ulcer prevention; not evidence for this historical formula2026-10-13
NHS — Sore nipples, Best Start in LifeCurrent public guidance retrieved 2026-10-13Causes and early assessmentNipple pain often requires attachment/clinical assessment; does not validate glycerinated alcohol2026-10-13
Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp.51–58Nonsterile preparation risk assessment, equipment, packaging and quality controls; not Greek legislation2026-10-13
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