Triethanolamine 50% w/v auxiliary solution
CGR-BR-004 · ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
HISTORICAL SOURCE EDITION — compare with the current edition before use.
Source formula
| Ingredient | Source quantity |
|---|---|
| Triethanolamine | 50 g |
| Purified water | q.s. ad 100 mL |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Partial evidenceLiquid base or auxiliary solution: Triethanolamine 50% w/v auxiliary solution. Additional appearance criteria are not established by the specific text reviewed.
References: [1]
Use and action
Documented in sourceAlkaline pH-adjustment/emulsification intermediate.
References: [1]
Specifications
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Light
Partial evidenceFor the finished product the source specifies:
Opaque plastic or amber glass, protected from light, room temperature.
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
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Temperature
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
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
Partial evidenceEthanol is incompatible with strong oxidants.
References: [2]
Ingredient-specific information
Partial evidenceTriethanolamine: 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 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 evidenceEthanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
References: [2]
Compounding conditions
Partial evidenceFollow 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]
BUD rationale
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
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 evidenceNo separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.
References: [1]
Equipment
Editorial checklistIndicative 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 sourceMix triethanolamine and water with stirring to the stated reference quantity.
References: [1]
Observations
Documented in sourceAlkaline intermediate for pH adjustment/emulsification. Concentration is w/v.
References: [1]
Packaging
Documented in sourceOpaque plastic or amber glass, protected from light, room temperature.
References: [1]
Quality control
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Storage
Documented in sourceOpaque plastic or amber glass, protected from light, room temperature.
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_specimenTriethanolamine 50% w/v auxiliary solution
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Για εργαστηριακή ενσωμάτωση / For incorporation during compounding
Dose/directions: __________
Storage: Opaque plastic or amber glass, protected from light, room temperature.
References: [1]
Sources and traceability
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
2012, 2nd ed., Rev. 02 — superseded · PDF pp. 210 · A2
Review date reported in supplied metadata: 2026-09-10
- niosh_ethanol
Διαθέσιμο κείμενο / Retrieved text · Official reference · 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
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: 103c571c39cf6915beb16a67c8b4c688f53c89b9514f4e67c60595df1179e5bc