Starch glycerolate Ph. Fr.

Homogeneous translucent greyish hygroscopic gel; miscible with water. ^[1]

Dermatological use; no more specific indication is defined. ^[1]

Glycerol: 78.2–95.5% 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]

Glycerol is miscible with water. This does not establish product microbiological stability. ^[2]

Glycerol is hygroscopic; limit raw-material exposure to moisture. ^[2]

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

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

Glycerol: hazardous reaction with strong oxidising agents. ^[2]

Glycerol: clear, colourless, viscous and strongly hygroscopic liquid. It mixes with water but is practically insoluble in fixed and essential oils.
Glycerol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. ^{[2], [4]}

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], [5]}

Reference batch: 100 g. First ingredient: Glycerol, 86.8 g. Independently check chemical form, units and every scale conversion before weighing.
As an intermediate, label identity and strength clearly and do not dispense as a finished medicine. Dilution or addition of an active requires new excipient, preservation and BUD calculations. Confirm release of every required base.
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], [9], [11]}

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], [5]}

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], [7], [8], [10], [12]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[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 starch at 250 µm, disperse in water and add glycerol. Stir at 100–105 °C until thickened; cool. Avoid stainless steel. ^[1]

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

Airtight container. ^[1]

Glycerol: 0.085 g in 45 mL water, oxidise with 25.0 mL 0.1 M H2SO4/0.1 M NaIO4 mixture (1:20), 15 min protected from light. Add 5.0 mL ethylene glycol 500 g/L, wait 20 min protected from light. Titrate with 0.1 M NaOH/phenolphthalein and a blank; 1 mL equals 9.21 mg glycerol.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [4], [11]}

Airtight container.
For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. ^{[1], [6]}

Intermediate base for compounding. Adding an active requires reassessment of the final composition, pH, preservation and BUD. ^[1]

Starch glycerolate Ph. Fr.
Compounding base — not for direct administration
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Airtight container.
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.