Metronidazole Benzoate Suspension 200 mg/5 mL as Metronidazole

Oral suspension: Metronidazole Benzoate Suspension 200 mg/5 mL as Metronidazole. Additional appearance criteria are not established by the specific text reviewed. ^[1]

Nitroimidazole antiprotozoal and antibacterial. ^[1]

FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply. ^[1]

Polysorbate 80: JP requires light protection for the raw material. ^[4]

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

Polysorbate 80: JP classifies the corresponding pure raw material as miscible in water.
Sodium Benzoate: JP classifies the corresponding pure raw material as freely soluble in water.
Component of base CGR-BE-003: Methyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as slightly soluble in water.
Component of base CGR-BE-003: Propyl Parahydroxybenzoate: JP classifies the corresponding pure raw material as very slightly soluble in water. ^{[4], [5], [8], [9], [10]}

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:
100 mL bottle with dosing pipette; 15–25 °C. ^[1]

Benzoic acid/benzoate preservation is described by EMA in acidic conditions, pH 2.5–4.5. Preservation at higher pH must not be assumed. ^[3]

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

Metronidazole benzoate quantity is expressed as metronidazole equivalent; ester and free active are not interchangeable by mass.
Polysorbate 80: raw-material water solubility is classified as miscible by JP. Protect the raw material from light.
Sodium Benzoate: raw-material water solubility is classified as freely soluble by JP.
Component of base CGR-BE-003: Methyl Parahydroxybenzoate: raw-material water solubility is classified as slightly soluble by JP.
Component of base CGR-BE-003: Propyl Parahydroxybenzoate: raw-material water solubility is classified as very slightly soluble by JP. ^{[1], [4], [5], [8], [9], [10]}

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

Benzoic acid/benzoates may worsen neonatal jaundice through bilirubin displacement. Assess use in neonates up to 4 weeks; topical exposure can also irritate.
Reference batch: 101.4 g (=100 mL στην πηγή / in source). First ingredient: Metronidazole benzoate, 6.44 g. Independently check chemical form, units and every scale conversion before weighing.
Redispersibility is critical: homogenise before subdivision, check for hard sediment and verify that the graduated oral syringe delivers the required volume without blockage/air. Clarity is not an acceptance criterion for a suspension.
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: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity. ^{[1], [3], [12], [14]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [6]}

Period reported by source: Historical validity: 2 months; in-use limit 2 months, within overall expiry.
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. ^{[1], [7], [11], [13], [15]}

MCC/carmellose dispersion FTM: CGR-BE-007
Strong bitter-orange epicarp/mesocarp tincture FTM — qualified exact-source auxiliary; ordinary orange flavour is not equivalent ^[1]

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

Triturate ester with cellulose dispersion in portions. Dissolve saccharin, sodium benzoate and polysorbate in 10 g freshly boiled and cooled water. Incorporate, add tincture, rinse/transfer and make up to 101.4 g. ^[1]

Source equivalence: 6.44 g ester = 4.00 g metronidazole. Use qualified tincture to the specified standard, not ordinary orange flavour. ^[1]

100 mL bottle with dosing pipette. ^[1]

FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply.
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], [14]}

100 mL bottle with dosing pipette; 15–25 °C. ^[1]

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

Metronidazole Benzoate Suspension 200 mg/5 mL as Metronidazole
Oral use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: 100 mL bottle with dosing pipette; 15–25 °C.
Shake/redisperse well before use.
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.