Urea hydrophilic cream 10% FTM

Cream: Urea hydrophilic cream 10% FTM. Additional appearance criteria are not established by the specific text reviewed. ^[1]

Ichthyosis and hyperkeratoses. ^[1]

Composition and final quantity follow the formula table (50 g). The reviewed specific text gives no numerical assay, microbial-count or physicochemical acceptance range; no unsupported limit is assigned. ^[1]

Finished-product photostability is not specified. Any required container light protection is stated under Storage. ^[1]

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

Urea is water-soluble.
Component of base CGR-BE-004: White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water.
Component of base CGR-BE-004: Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. ^{[2], [6], [7], [8]}

Urea is hygroscopic. ^[2]

For the finished product the source specifies:
Tube, 15–25 °C. ^[1]

No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. ^[1]

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

Identity and weighing basis:
• Urea: 5 g.
• Buffered cetomacrogol cream FTM: q.s. ad 50 g.
The specified chemical forms/grades belong to the exact source formula.
Component of base CGR-BE-004: White Petrolatum: raw-material water solubility is classified as practically insoluble by JP.
Component of base CGR-BE-004: Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP. ^{[1], [6], [7], [8]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. ^{[1], [3], [4]}

Reference batch: 50 g. First ingredient: Urea, 5 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. ^{[1], [10], [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], [4]}

Period reported by source: 2 months; 7 days without preservative.
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.
v9 variant-selection correction: the printed formula uses preserved base/water. Its reference ceiling is up to 35 days only where final-mixture preservation is supported. FTM’s 7 days at 15–25 °C applies exclusively to a separately documented preservative-free formulation. Do not transfer 7 days to the preserved branch or 35 days to the unpreserved branch. The 7-day period is a specific historical FTM instruction, not a room-temperature application of the general refrigerated 14-day rule. ^{[1], [5], [9], [11], [13]}

Buffered cetomacrogol cream FTM: CGR-BE-004 ^[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 urea with about 5 g base. Gradually incorporate the remainder to 50 g and homogenise. ^[1]

The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. ^[1]

Tube as specified by the procedure. ^[1]

Inspect appearance, uniformity/aggregates and final mass. No specific validated analytical method for the finished mixture was located in the source. These proposed in-process checks do not replace assay or microbiological testing when required.
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], [12]}

Tube, 15–25 °C. ^[1]

Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. ^{[1], [14]}

Urea hydrophilic cream 10% FTM
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tube, 15–25 °C.
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. ^{[1], [14]}

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.