Capsule diluent 2 EX014
CGR-ES-050 · FN/2003/EX/014 EXCIPIENTE N.º 2 PARA CÁPSULAS
WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.
Source formula
| Ingredient | Source quantity |
|---|---|
| Magnesium stearate | 1 g |
| Talc | 3 g |
| Maize starch | 96 g |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Documented in sourceWhite powder.
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 sourceWhite powder.
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
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
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
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
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
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, Mortar and pestle. Selection/qualification is defined locally.
References: [1]
Preparation procedure
Documented in sourceMix about one third of the starch with magnesium stearate, then talc. Incorporate the remaining two thirds successively. Mix for 15–30 min depending on quantity in a tumbling mixer, or a mortar for small quantities only.
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 in a cool dry place. No numerical temperature range is given.
References: [1]
Quality control
Partial evidenceWhite powder.
References: [1]
Storage
Documented in sourceOpaque jar in a cool dry place. No numerical temperature range is given.
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_specimenCapsule diluent 2 EX014
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Για εργαστηριακή ενσωμάτωση / For incorporation during compounding
Dose/directions: __________
Storage: Opaque jar in a cool dry place. No numerical temperature range is given.
References: [1]
Sources and traceability
- FN/2003/EX/014 EXCIPIENTE N.º 2 PARA CÁPSULAS
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
- 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/OF/002/00 MEZCLADO DE POLVOS
Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · 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: ece30a41dd6812e0794d3152c7bb97410b2fa2e90c9e9ebb7ea61c535f7508b9