REFERENCE FORMULA
Reference formula
Reference basis: 100 mL
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Calamine | 8 g | — |
| Zinc oxide | 8 g | — |
| Glycerol | 2 mL | — |
| Bentonite magma EX023 | 25 mL | — |
| 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-ES-065 · Calamine lotion PO014
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
Documentation
Preparation description
Whitish fine glossy suspension with characteristic odour. [1]
Action and use
Relief of itching/skin irritation. [1]
Specifications
Whitish fine glossy suspension with characteristic odour. [1]
Light
For the finished product the source specifies:
Airtight plastic bottle, protect from light, <30°C. [1]
Airtight plastic bottle, protect from light, <30°C. [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
Glycerol is miscible with water. This does not establish product microbiological stability.
Calamine is practically insoluble in water/ethanol.
ZnO: practically insoluble in water and ethanol.
Component of base CGR-ES-017: Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. [2], [3], [4], [12], [13], [14], [15]
Calamine is practically insoluble in water/ethanol.
ZnO: practically insoluble in water and ethanol.
Component of base CGR-ES-017: Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. [2], [3], [4], [12], [13], [14], [15]
Humidity
Glycerol is hygroscopic; limit raw-material exposure to moisture.
Component of base CGR-ES-017: Propylene glycol is hygroscopic; close its container promptly after measuring.
Component of base CGR-ES-017: Propylene Glycol: the raw material is hygroscopic according to JP. [2], [11], [12], [13]
Component of base CGR-ES-017: Propylene glycol is hygroscopic; close its container promptly after measuring.
Component of base CGR-ES-017: Propylene Glycol: the raw material is hygroscopic according to JP. [2], [11], [12], [13]
Temperature
For the finished product the source specifies:
Airtight plastic bottle, protect from light, <30°C. [1]
Airtight plastic bottle, protect from light, <30°C. [1]
pH and compatibility
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.
Calamine of the cited specification is basic zinc carbonate containing traces of iron(III) oxide. Sieving and trituration reduce aggregates; wet the suspension powder with the formula’s polyol component.
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
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.
Component of base CGR-ES-017: Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Component of base CGR-ES-017: Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. [2], [3], [4], [8], [11], [12], [13], [14], [15]
Calamine of the cited specification is basic zinc carbonate containing traces of iron(III) oxide. Sieving and trituration reduce aggregates; wet the suspension powder with the formula’s polyol component.
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
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.
Component of base CGR-ES-017: Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Component of base CGR-ES-017: Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Component of base CGR-ES-017: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-ES-017: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. [2], [3], [4], [8], [11], [12], [13], [14], [15]
Staff protection
Risk assessment
Component of base CGR-ES-017: Propylene glycol: assess exposure from all medicines, especially in neonates, children under 5 and renal/hepatic impairment. For oral dosing: mg/kg/day = mg/mL × daily mL ÷ body weight in kg.
Reference batch: 100 mL. First ingredient: Calamine, 8 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
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], [11], [12], [17], [19]
Reference batch: 100 mL. First ingredient: Calamine, 8 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
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], [11], [12], [17], [19]
Compounding conditions
The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. [1], [6]
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. [1], [6]
BUD rationale
Period reported by source: 2 weeks according to the source.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
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], [10], [16], [18], [20]
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected conservative general rule: up to 14 days at 2–8 °C for an aqueous form without adequately established preservation. Refrigeration must not cause precipitation, irreversible separation or other loss of suitability. If that condition fails, do not apply 14 days at room temperature; obtain specific short-use evidence.
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], [10], [16], [18], [20]
Prerequisites
AEMPS EX023 Bentonite magma: CGR-ES-057 [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
Observations
The 25 g is an aliquot of already diluted magma, not a replacement for the 25 mL original EX023. The main text cites the solution SOP, while environment/form refer to suspensions. [1]
Container and packaging
Airtight plastic bottle, protect from light, <30°C. [1]
Quality control
Whitish fine glossy suspension with characteristic odour.
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: sedimentation rate, viscosity RFE 2.2.8, relative density 2.2.5, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
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. [1], [6], [7], [8], [19]
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: sedimentation rate, viscosity RFE 2.2.8, relative density 2.2.5, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
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. [1], [6], [7], [8], [19]
Storage
Dispensing
Shake. Not under 2 years, on eyes/mucosa/open wounds or infected dermatoses. Do not use beyond 7 days without medical advice. [1]
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
- FN/2003/PO/014 CALAMINA, LOCIÓN DEFN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022PDF pp. 2–4master formula2026-09-10
- FN/2003/PA/013 GLICEROLΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/008 CALAMINAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–2raw material or occupational2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCΔιαθέσιμο 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
- PN/L/FF/008/00 ELABORACIÓN DE SUSPENSIONESΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–6preparation sop2026-09-10
- PN/L/CP/001/00 DETERMINACIÓN DE PHΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5qc method2026-09-10
- 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
- EMA — Questions and answers on propylene glycol used as an excipient, EMA/CHMP/704195/20139 October 2017Sections 1–3 and annexingredient facts2026-09-12
- FN/2003/EX/025 SOLUCIÓN CONCENTRADA DE HIDROXIBENZOATOS2003PDF pp. 2master formula2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Propylene GlycolJP XVIII, 2021; English textPrinted p. 1600; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Methyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1343; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Propyl ParahydroxybenzoateJP XVIII, 2021; English textPrinted p. 1601; Description; Containers and storageraw-material monograph2026-09-12
- 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