The 19 special cases

CGR-ES-003

AEMPS preserved syrup — nominal 84% w/v

EX029 theoretical basis reconciled with a second source. No ratio change; local adoption required. No new stability experiment.

CGR-ES-011

Hydrocortisone oral suspension 1 mg/mL AEMPS

EX029 theoretical basis reconciled with a second source. No ratio change; local adoption required. No new stability experiment.

CGR-ES-012

Gabapentin oral solution 50 mg/mL AEMPS

EX029 theoretical basis reconciled with a second source. No ratio change; local adoption required. No new stability experiment.

CGR-ES-013

Sodium citrate/citric acid oral solution AEMPS

EX029 theoretical basis reconciled with a second source. No ratio change; local adoption required. No new stability experiment.

CGR-ES-033

Dexamethasone Oral Solution 1 mg/mL

EX029 theoretical basis reconciled with a second source. No ratio change; local adoption required. No new stability experiment.

CGR-BR-002

Citric acid 25–50% w/v auxiliary solution

Stored-stock requirement removed by restricting use to a fresh intermediate in the same continuous operation. No stored shelf life established.

CGR-BR-003

Imidazolidinyl urea 50% w/v preservative solution

Stored-stock requirement removed by restricting use to a fresh intermediate in the same continuous operation. No stored shelf life established.

CGR-BR-004

Triethanolamine 50% w/v auxiliary solution

Stored-stock requirement removed by restricting use to a fresh intermediate in the same continuous operation. No stored shelf life established.

CGR-BR-010

Sodium chloride 25% w/v thickening intermediate

Stored-stock requirement removed by restricting use to a fresh intermediate in the same continuous operation. No stored shelf life established.

CGR-ES-015

Urea cream 15% AEMPS

Specify urea incorporation without violating the no-heating instruction. Study assay/degradation with a suitable method, pH, crystallisation, uniformity and preservation in exact EX010. A general hot process for other urea creams does not validate this formula.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-ES-047

Water-in-silicone emulsion EX006

Require named grade, complete composition/active emulsifier fraction and compatibility data for the specified water, cyclomethicone and electrolytes. Verify emulsion type, structure, uniformity, preservation and container compatibility. Shared INCI or another mixer’s rpm is insufficient.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-FR-008

Oleo-calcareous cream Ph. Fr.

Retain the ANSM limit ≤30 °C. A confirmed process for the actual wool fat and petrolatum must document rheological state, incorporation and uniformity. Cold processing may be investigated as local development; it is not pharmacopoeial validation.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BP-015

Emulsifying Wax

Measure finished wax after cooling and equilibration with a matrix-suitable method. Link to raw-material lots, residual moisture and packaging. For this edition’s conservative low-aw decision, the highest result plus uncertainty must be <0.60; this uncertainty rule is editorial policy, not a verbatim USP criterion.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BP-033

Flexible Collodion

The matrix contains volatile organic solvents. The laboratory must demonstrate selective water-vapour measurement without interference or solvent loss and representative sampling. A binary ethanol–water table does not establish collodion aw. Passing aw does not replace evaporation and closure-function checks.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-FR-006

Collodion Ph. Fr.

Require a specific measurement or reliable published aw for this exact collodion with actual solvents and container documented. Check method suitability for volatile matrices; water content or dry residue is not aw. Do not transfer another collodion’s shelf life.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BE-027

Crotamiton Emulsion 10% w/w

The historical source specifies two months at room temperature. Applying a 14-day default first requires 2–8 °C compatibility: emulsion structure, uniformity, behaviour after storage and assay. Alternatively document a period for the exact formula at its original temperature. Crotamiton antiseptic activity is not a preservative challenge test.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BR-013

Aluminium hydroxide 6% w/v suspension

For the exact alkaline matrix study pH, acid-neutralising capacity, settling/redispersibility, syringe-delivered dose and microbiology. Sodium benzoate presence does not establish effective preservation at alkaline pH. Refrigeration requires evidence of physical compatibility before using the 14-day default.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BR-014

Aluminium hydroxide 6% and magnesium hydroxide 4% w/v suspension

Check pH, uniformity and acid-neutralising capacity of the exact formula together with redispersibility, dosing device and microbiology. Absence of crystals just after preparation does not establish behaviour under refrigeration or in use. Sodium benzoate alone does not prove preservation.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.

CGR-BR-016

Simple syrup 85% w/v — FNFB

Stored syrup needs exact sucrose/water evidence: final mass fraction, density, crystallisation, aw and microbiological behaviour including relevant yeasts. The designation 85% w/v does not establish aw <0.60. Do not transfer dating from a differently formulated preserved syrup.

Close only after the evidence above is supplied and evaluated, a documented decision is recorded and local approval is granted. Execution remains on hold meanwhile.