Sertraline 25 / 50 mg capsules

Hard capsules: Sertraline 25 / 50 mg capsules. Additional appearance criteria are not established by the specific text reviewed.

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Selective serotonin reuptake inhibitor.

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Mean fill mass 126–154 mg, nominal 140 mg. Mean assay 90–110%. Test mass on 20 capsules and content on 10 in the control batch; full criteria in the original.

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For the finished product the source specifies:
PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg.

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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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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:
PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg.

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

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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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Source period: 5 weeks.
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, Capsule-filling equipment. Selection/qualification is defined locally.

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Select one of the two quantity columns. Mix micronised API and lactose using the studied source method: Topitec, 500 mL pot, 5 balls, 500 rpm for 10 min. Fill size 4 capsules evenly and test. Another mixer requires blend-uniformity qualification.

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Strengths are sertraline base; weigh hydrochloride: 27.98 / 55.96 mg per capsule. Do not freely exchange API or lactose grades; the note requires suitable dissolution and blend validation for alternatives.

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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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Mass uniformity of 20 random units by Ph. Eur. 2.9.5 and content/unit tests in the specific analytical annex. Use the exact limits for the selected strength. The full annex is required for execution.

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PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg.

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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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Sertraline 25 / 50 mg capsules
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: PET without desiccant, 15–25 °C, dry, protected from light. Distinct shells: single-colour 25 mg, two-colour 50 mg.

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