ALUMINUM HYDROXIDE GEL USP
Aluminum hydroxide is produced under international Good Manufacturing Practice (GMP) certification. This compound is the main ingredient in the production of non-systemic antacids. When combined with magnesium hydroxide or used alone, it is one of the most employed antacids on the market, as both react chemically with the acid present in the stomach. The inclusion of aluminum hydroxide in antacid formulations is due to its ability to neutralize acidity and create a buffer that provides a prolonged effect, with minimal side effects and a reduced level of intestinal absorption. Aluminum hydroxide has an amorphous nature and contains carbonate in its structure, generating aluminum polihydroxicarbonate complexes that enhance its reactivity against gastric acids.
| Product Properties | Aluminum Hydroxide Gel (High Viscosity) | Aluminum Hydroxide Pumpable Gel |
|---|---|---|
| Description | High viscosity gel | Pumpable gel |
| Reference | HVA 14-0700 | LVA 20 -0400P |
| Physicochemical Parameters | ||
| Appearance | Soft white gel | Fluid gel |
| Concentration % Al(OH)3 | 13,6 – 16,6 | 19,1 – 21,4 |
| Acid Neutralizing Capacity | > 3,4 mEq/g | > 4,8 mEq/g |
| pH | 5,5 – 8,0 | 5,5 – 8,0 |
| Chlorides | < 4.7% based on % Al(OH) 3 | < 0,28% |
| Sulfates | < 0.8% based on % Al(OH) 3 | < 0,4% |
| Arsenic | < 10 ppm based on % Al(OH)3 | < 1,3 ppm |
| Viscosity | > 800 cP (6.12% Al(OH)3 suspension, spindle 2 at 12 rpm / 30 sec) | 400 – 2000 cP (direct, spindle 2 at 12 rpm / 30 sec) |
| Microbiological Parameters | ||
| Microbial Total Aerobic Count | < 10 UFC/g | < 10 UFC/g |
| Molds and Yeasts | < 10 UFC/g | < 10 UFC/g |
| E. Coli | Absence | Absence |