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Quetiapine 50 / 100 / 150 mg immediate-release capsules

CGR-FR-034 · ANSM — Monographie de préparation magistrale (outside Formulaire national)

For local reviewCGR-FR-034France

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

Quetiapine: main monograph/tables specify fumarate; note has an isolated chlorhydrate reference. Exact monograph composition retained. Extension from 6 to 12 weeks requires the note p.5 conditions.

Quetiapine: main monograph/tables specify fumarate; note has an isolated chlorhydrate reference. Exact monograph composition retained. Extension from 6 to 12 weeks requires the note p.5 conditions.

Monograph PDF · GR/ENBlank batch worksheet
Dosage formHard capsules
Reference batch1 καψάκιο / capsule; επιλέξτε μία ισχύ / select one strength
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Quetiapine fumarate, for 50 / 100 / 150 mg base57.56 / 115.12 / 172.68 mg
Colloidal anhydrous silica, respectively0.5 / 1 / 1.5 mg
Opaque gelatin shell, size 4 / 2 / 1 respectively1

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

Description

Partial evidence

Hard capsules: Quetiapine 50 / 100 / 150 mg immediate-release capsules. Additional appearance criteria are not established by the specific text reviewed.

References: [1]

Use and action

Documented in source

Antipsychotic; this preparation is immediate-release.

References: [1]

Specifications

Documented in source

Mean fill mass for 50 / 100 / 150 mg: 52.3–63.9 / 104.5–127.7 / 156.8–191.6 mg. Mean assay 90–110%. Full mass/content-uniformity procedure in original.

References: [1]

Light

Partial evidence

For the finished product the source specifies:
Suitable closed container, 15–25 °C, dry, protected from light.

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:
Suitable closed container, 15–25 °C, dry, protected from light.

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

Not established

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

References: [1]

Ingredient-specific information

Not established

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

References: [1]

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

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.

References: [1]

Compounding conditions

Partial evidence

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]

BUD rationale

Documented in source

Base monograph: 6 weeks. The note permits 12 weeks only under the specific API, shell and packaging conditions in its page 5 table. Extension is not automatic.
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, Mortar and pestle, Capsule-filling equipment. Selection/qualification is defined locally.

References: [1]

Preparation procedure

Documented in source

Calculate for one strength and capsule count. Weigh quetiapine fumarate and silica, triturate and blend. Fill, close, check count/mass and package.

References: [1]

Observations

Documented in source

IMMEDIATE release: no automatic substitution for an XR product. The salt is fumarate, not hydrochloride; an isolated “chlorhydrate” in the note is logged as an editorial inconsistency. The three columns are alternative strengths.

References: [1] · [2]

Packaging

Documented in source

Suitable closed container, 15–25 °C, dry, protected from light.

References: [1]

Quality control

Documented in source

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.

References: [1]

Storage

Documented in source

Suitable closed container, 15–25 °C, dry, protected from light.

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

Quetiapine 50 / 100 / 150 mg immediate-release capsules
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Από του στόματος / Oral use
Dose/directions: __________
Storage: Suitable closed container, 15–25 °C, dry, protected from light.

References: [1]

Sources and traceability

  1. ANSM — Monographie de préparation magistrale (outside Formulaire national)

    v3 • 31/07/2025; note v1 • 31/07/2025 · PDF pp. 1–7; note 1–5 · A1

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

  2. fr_quetiapine

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

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: 14d8df35cf8e46035700fb1ff6923b48ee535b9fa2b0b61199aadd9fa837f354

Monograph PDF · GR/ENBlank batch worksheet