TO-GE KC-7
Methyl Salicylate, 15% and Menthol, 7% Hydroalcoholic Clear Gel Clear Gel This gel features Carbopol ® * 971P NF polymer which polymer which imparts viscosity and clarity to the formulation.
Ingredient Name Ingredient Name A
1. Methyl Salicylate, USP
15.00
2. Menthol, USP
7.00
3.
Carbopol ® 971P
Product Properties
%w/w
Appearance
Clear gel Clear gel
pH
6.5
Viscosity (cP)**
8,900
0.30
NF Polymer
**Brookfield RVT **Brookfield RVT @ @ 20 rpm, 20 rpm, Spindle #5, measured at measured at 24 24 hours
B
C
4. Ethanol
15.0
5. Propylene Glycol
20.0
6. Hydroxypropyl Cellulose Klucel ® HXF
0.60
7. Ethanol
20.0
8. Purified Water
21.50
9. 2-Amino-2-methyl-1 propanol (20% solution)
0.40
10. Lavender Fragrance Lavender Fragrance
Stability
- Stable for a for a minimum of 3 of 3 months when stored under the following ICH conditions:
0.20
Long term (25 ± 2°C / 60 ± 5% relative humidity)
Accelerated (40 ± 2°C / 75 ± 5% relative humidity)
Klucel® is a registered trademark of Ashland, of Ashland, Inc.
Procedure 1. Dissolve menthol in the methyl salicylate. Add in Carbopol ® 971P NF polymer and polymer and disperse. Add ethanol and propylene glycol and mix well. Keep the solution covered during mixing to prevent solvent evaporation (Part A). 2. Disperse the hydroxypropyl cellulose in ethanol using a homogenizer. Add the purified water and water and homogenize to obtain a clear, viscous solution (Part B). 3. Add Part B ingredients to Part A ingredients and mix thoroughly. 4. Slowly add the 20% 2-amino-2-methyl-1-propanol solution while mixing. Add fragrance and mix to obtain a clear, viscous gel (Part C).
Edition: June 1, 2011 Previous Edition: December 19, December 19, 2008
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