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Hydroalcoholic vehicle 1 EX026

CGR-ES-058 · FN/2003/EX/026 SOLUCIÓN HIDROALCOHÓLICA 1

For local reviewCGR-ES-058Spain · AEMPS

WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.

50 mL of 96% ethanol and 50 mL water are input volumes. Mixing contraction means a 100 mL final volume cannot be assumed.

50 mL of 96% ethanol and 50 mL water are input volumes. Mixing contraction means a 100 mL final volume cannot be assumed.

Monograph PDF · GR/ENBlank batch worksheet
Dosage formLiquid base or auxiliary solution
Reference batch50 + 50 mL όγκοι εισόδου / input volumes
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Ethanol 96%50 mL
Purified water50 mL

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

Transparent colourless solution.

References: [1]

Use and action

Documented in source

Base or auxiliary excipient for further compounding. Its BUD is not adopted unchanged after adding an active.

References: [1]

Specifications

Documented in source

Transparent colourless solution.

References: [1]

Light

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Air

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Water and solubility

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Humidity

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Temperature

Partial evidence

For the finished product the source specifies:
Amber bottle, well closed, <30°C.

References: [1]

pH and related incompatibilities

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Other incompatibilities

Partial evidence

Ethanol is incompatible with strong oxidants.

References: [2]

Ingredient-specific information

Partial evidence

Ethanol 96%: Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
These are selected facts for identified ingredients; relevant sensitivities and incompatibilities are detailed in the corresponding fields. This is not a complete SDS for every material.

References: [2]

Personal protective equipment

Partial evidence

Complete 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.

References: [1] · [3]

Risks and precautions

Partial evidence

Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

References: [2]

Compounding conditions

Documented in source

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.

References: [1] · [4]

BUD rationale

Documented in source

6 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

Partial evidence

No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

References: [1]

Equipment

Editorial checklist

Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials. Selection/qualification is defined locally.

References: [1]

Preparation procedure

Documented in source

Mix the two input volumes and stir until homogeneous. Do not arbitrarily add water to a 100 mL final volume.

References: [1] · [4]

Observations

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Packaging

Documented in source

Amber bottle, well closed, <30°C.

References: [1]

Quality control

Partial evidence

Transparent colourless solution.
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: colour, clarity/opalescence, relative density, 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.

References: [1] · [4] · [5]

Storage

Documented in source

Amber bottle, well closed, <30°C.

References: [1]

Dispensing and directions

Partial evidence

No 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_specimen

Hydroalcoholic vehicle 1 EX026
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Για εργαστηριακή ενσωμάτωση / For incorporation during compounding
Dose/directions: __________
Storage: Amber bottle, well closed, <30°C.

References: [1]

Sources and traceability

  1. FN/2003/EX/026 SOLUCIÓN HIDROALCOHÓLICA 1

    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

  2. niosh_ethanol

    Διαθέσιμο κείμενο / Retrieved text · Official reference · A1

    Review date reported in supplied metadata: 2026-09-10

  3. PN/L/PG/002/00 INDUMENTARIA

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1

    Review date reported in supplied metadata: 2026-09-10

  4. PN/L/FF/007/00 ELABORACIÓN DE SOLUCIONES

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · A1

    Review date reported in supplied metadata: 2026-09-10

  5. 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

Provenance and reuse

This record comes from the supplied v4 collection. Primary-source rights and licences remain separate. No new comprehensive licence review has been performed for the earlier 239 records.

SHA-256 of the supplied PDF: 9bddccda7de74115955c6c6f2610ce5eed7b7763989b660873ca96cf2cee0e94

Monograph PDF · GR/ENBlank batch worksheet