Zinc oxide starch glycerolate Ph. Fr.

Homogeneous white to nearly white semi-solid gel. ^[1]

Topical emollient and skin protectant according to the monograph. ^[1]

ZnO: 29.7–36.3% w/w ^[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]

ZnO: practically insoluble in water and ethanol.
Component of base CGR-FR-011: Glycerol is miscible with water. This does not establish product microbiological stability. ^{[2], [6], [7]}

Component of base CGR-FR-011: Glycerol is hygroscopic; limit raw-material exposure to moisture. ^{[6], [7]}

No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. ^[1]

ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. ^[2]

Component of base CGR-FR-011: Glycerol: hazardous reaction with strong oxidising agents. ^{[6], [7]}

Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Component of base CGR-FR-011: Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils. ^{[2], [6], [7]}

Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. ^{[1], [3], [4]}

Reference batch: 100 g. First ingredient: Zinc oxide, 33 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
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. ^{[1], [10], [12]}

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]}

No specific experimental period was located covering the complete exact formulation, container and microbiological suitability.
The glycerolate base contains 86.8% glycerol, 6.6% starch and 6.6% water by mass. The binary-mixture study reports aw about 0.34 at initial glycerol volume fraction 0.85. This supports a low-aw working category only with pharmacopoeial glycerol approximately 98% or higher, the exact heating process and no additional water. It is not a finished-paste measurement or a 180-day study; verify the suitability of this representative estimate in the quality system.
Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
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], [8], [9], [11], [13]}

Starch glycerolate Ph. Fr.: CGR-FR-011 ^[1]

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

Sieve ZnO at 250 µm. Coat the mortar with one third of the base; successively incorporate ZnO and remaining base. ^[1]

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

Tube or airtight jar. ^[1]

ZnO: 0.200 g in 10 mL dilute HCl and 20 mL water, then 170 mL water. Complexometry Ph. Eur. 2.5.11; 1 mL 0.1 M EDTA equals 8.14 mg ZnO. Check about 0.2 g for homogeneity, with no visible white aggregates.
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 or airtight jar.
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. ^{[1], [5]}

Dispense with a clear route, strength and use-by date. Complete amount per application and frequency from the prescription. ^[1]

Zinc oxide starch glycerolate Ph. Fr.
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Tube or airtight jar.
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.