Anionic O/W emulsion EX007
CGR-ES-043 · FN/2003/EX/007 EMULSIÓN O/A ANIÓNICA
Existing supporting base; reissued with provenance/reuse conditions. Not counted as a new monograph.
Source formula
| Ingredient | Source quantity |
|---|---|
| Emulsifying cetostearyl alcohol Type B | 15 g |
| Decyl oleate | 15 g |
| Propylene glycol | 5 g |
| Preserved water AEMPS EX001 | q.s. ad 100 g |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Documented in sourceFirm white emulsion.
References: [1]
Use and action
Documented in sourceBase or auxiliary excipient for further compounding. Its BUD is not adopted unchanged after adding an active.
References: [1]
Specifications
Documented in sourceFirm white emulsion.
References: [1]
Light
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Air
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Water and solubility
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Humidity
Partial evidenceFor the finished product the source specifies:
Opaque jar, protect from moisture, <30°C.
References: [1]
Temperature
Partial evidenceFor the finished product the source specifies:
Opaque jar, protect from moisture, <30°C.
References: [1]
pH and related incompatibilities
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Other incompatibilities
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Ingredient-specific information
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Personal protective equipment
Partial evidenceComplete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.
Risks and precautions
Partial evidenceA complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.
References: [1]
Compounding conditions
Documented in sourceThe 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.
BUD rationale
Documented in source6 months under the source conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.
References: [1]
Bases and dependencies
Documented in sourceAEMPS EX001 Preserved water → CGR-ES-018
Equipment
Editorial checklistIndicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Controlled heating and thermometer, Calibrated pH meter. Selection/qualification is defined locally.
References: [1]
Preparation procedure
Documented in sourceSeparate oil and aqueous phases. Heat both to 70–75°C. Under PN/L/FF/002/00, add the aqueous phase to the oil phase with controlled mixing and continue moderate mixing during cooling.
Observations
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Packaging
Documented in sourceOpaque jar, protect from moisture, <30°C.
References: [1]
Quality control
Partial evidenceFirm white emulsion.
Additional tests from the referenced SOP:
Appearance and mass. For batches: spreadability PN/CP/003, emulsion type PN/CP/002, pH of O/W emulsions PN/CP/001 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.
Spreadability PN/CP/003: fixed sample quantity between glass plates, with locally defined successive loads and times; measure two diameters and compare area against load. Temperature variation of ±0.5°C is suggested. The source gives no universal acceptance limit; establish it locally.
Storage
Documented in sourceOpaque jar, protect from moisture, <30°C.
References: [1]
Dispensing and directions
Partial evidenceNo additional special directions are established beyond the source route, storage and notes. Complete patient details, dose and directions from the prescription.
References: [1]
Labelling
editorial_specimenAnionic O/W emulsion EX007
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Για εργαστηριακή ενσωμάτωση / For incorporation during compounding
Dose/directions: __________
Storage: Opaque jar, protect from moisture, <30°C.
References: [1]
Sources and traceability
- FN/2003/EX/007 EMULSIÓN O/A ANIÓNICA
FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022 · PDF pp. 2 · A1
Review date reported in supplied metadata: 2026-09-10
- AEMPS EX001 Preserved water
See exact source · Complete base monograph · A1
Review date reported in supplied metadata: 2026-09-10
- PN/L/PG/002/00 INDUMENTARIA
Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1
Review date reported in supplied metadata: 2026-09-10
- PN/L/FF/002/00 ELABORACIÓN DE EMULSIONES
Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · A1
Review date reported in supplied metadata: 2026-09-10
- PN/L/CP/001/00 DETERMINACIÓN DE PH
Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1
Review date reported in supplied metadata: 2026-09-10
- PN/L/CP/003/00 DETERMINACIÓN DE EXTENSIBILIDAD
Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · A1
Review date reported in supplied metadata: 2026-09-10
- AEMPS — Aviso legal
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
- BOE — Real Decreto 1495/2011, artículos 7–10 y anexo
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
Provenance and reuse
Source: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), Formulario Nacional. Original Greek/English rendering and restructuring: Greek Formulary Sikalias, Stasinos Chr. Sikalias, compounding.gr. Reuse basis: AEMPS legal notice and RD 1495/2011, Articles 7–10/Annex. Composition and units retained; references, distinct editorial notes and blank batch fields added. AEMPS endorsement is not implied. Edition code appears in the reference; NIPO 134-20-002-3 / 090-22-245-5. The PDFs do not state an exact internal revision date. Access checked 10 September 2026.
SHA-256 of the supplied PDF: 852169cdb41fb2af02d47ddf3265f235304f5a589a4f138677ce936f2e5323f1