Aluminium hydroxide 6% and magnesium hydroxide 4% w/v suspension

Oral suspension: Aluminium hydroxide 6% and magnesium hydroxide 4% w/v suspension. Additional appearance criteria are not established by the specific text reviewed.

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Antacid.

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

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For the finished product the source specifies:
Well-closed opaque plastic or amber glass, protected from light, room temperature.

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

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Glycerol is miscible with water. This does not establish product microbiological stability.

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Glycerol is hygroscopic; limit raw-material exposure to moisture.

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

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

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Glycerol: hazardous reaction with strong oxidising agents.

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Glycerol: Glycerol is hygroscopic; limit raw-material exposure to moisture.
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.

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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.

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A 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.

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Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

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No 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.

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

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

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Disperse carmellose in glycerol and add some water. Incorporate sieved hydroxide powders into a uniform paste. Separately dissolve saccharin, sodium benzoate and flavour in water; combine and make to volume with stirring.

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Shake before use. Qualify high-viscosity carmellose grade. No numerical redispersion or assay criteria specified.

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Well-closed opaque plastic or amber glass, protected from light, room temperature.

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

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Well-closed opaque plastic or amber glass, protected from light, room temperature.

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No additional special directions are established beyond the source route, storage and notes. Complete patient details, dose and directions from the prescription.

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Aluminium hydroxide 6% and magnesium hydroxide 4% w/v suspension
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Well-closed opaque plastic or amber glass, protected from light, room temperature.
Shake before use.

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