Amlodipine 0.5 mg/mL oral solution

Clear, slightly yellow solution. ^{[1], [7]}

Dihydropyridine calcium-channel blocker. ^[1]

pH 5.5–6.5 ^[1]

For the finished product the source specifies:
Amber glass screw-cap bottle, 2–8 °C; protect from light.
Amlodipine Besilate: JP requires light protection for the raw material. ^{[1], [5]}

No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. ^[1]

Amlodipine Besilate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-002: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-ES-002: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water.
Component of base CGR-ES-022: Sucrose: JP classifies the corresponding pure raw material as very soluble in water. ^{[5], [9], [10], [11], [12], [13]}

No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. ^[1]

For the finished product the source specifies:
Amber glass screw-cap bottle, 2–8 °C; protect from light. ^[1]

Specification of this preparation, not a demonstrated stability range:
pH 5.5–6.5 ^[1]

No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. ^[1]

Amlodipine Besilate: raw-material water solubility is classified as slightly soluble by JP. Protect the raw material from light.
Component of base CGR-ES-002: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-ES-002: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP.
Component of base CGR-ES-022: Sucrose: raw-material water solubility is classified as very soluble by JP. ^{[5], [9], [10], [11], [12], [13]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [2], [6]}

Reference batch: 100 mL. First ingredient: Amlodipine besilate, 69 mg. Independently check chemical form, units and every scale conversion before weighing.
Check complete dissolution and crystallisation at the selected temperature. Calculate dose volume from the exact mg/mL, not the starting tablet or stock strength. Supply a suitable oral syringe.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: confirm final volume or mass at the reference temperature, intended clarity or dispersion, and specified container/closure. Do not equate grams and millilitres without a justified density. ^{[1], [15], [17]}

The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment. ^{[1], [3]}

Period reported by source: 60 days; 30 days in use.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP clarification: aw measurement is not required for every nonsterile preparation. Category assignment may use the exact composition and relevant representative examples; an uncertain or borderline formulation is best assessed by a suitable specific measurement. This edition contains no measured aw or released batch. The final preparation generally must not outlast the remaining BUD of its compounded bases/intermediates. An exception requires specific justification that physical, chemical and microbiological quality is not adversely affected. Record the final limit, intermediate preparation dates and their actual expiry dates separately.
Closed/in-use distinction: this edition’s closed-container reference ceiling is 35 days subject to its stated prerequisites. After opening use no longer than 30 days and never beyond the previously assigned overall expiry. Opening does not restart the overall BUD. ^{[1], [7], [8], [14], [16], [18]}

Preserved water without propylene glycol AEMPS: CGR-ES-002
FN/2003/EX/022 JARABE SIMPLE (84% P/V). Modificado 2020: CGR-ES-022 ^[1]

Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities.
Calibrated pH meter and suitable check buffers. ^[1]

1. Weigh 69 mg amlodipine besilate, equivalent to 50 mg amlodipine base.
2. Measure 25 mL simple syrup EX022.
3. Dissolve the drug in a portion of preserved water without propylene glycol.
4. Add the 25 mL syrup and mix until clear.
5. Transfer quantitatively, rinsing with the same preserved water.
6. Make to a final 100 mL with this water and mix.
7. Check clarity, final volume and pH 5.5–6.5; package in an amber glass screw-cap bottle. ^{[1], [7]}

Besilate-to-base factor 1.38. Sucrose approximately 0.21 g/mL and parabens are present; assess patient exposure/intolerance. ^[7]

Amber glass screw-cap bottle, 2–8 °C; protect from light. ^[1]

pH 5.5–6.5
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: colour, clarity/opalescence, relative density, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [3], [4], [17]}

Amber glass screw-cap bottle, 2–8 °C; protect from light. ^[1]

Dispense the exact prescribed strength. For liquids use a suitable graduated oral syringe; record dose and frequency from the prescription. ^[1]

Amlodipine 0.5 mg/mL oral solution
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Amber glass screw-cap bottle, 2–8 °C; protect from light.
Temperature for this batch BUD: ____ ^[1]

The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.