Specification: 20kg/barrel
chem: AI(OH)₃
QS: USP46
Usage: It has the functions of anti-acid, sorption, local hemostasis and protection of ulcer surface, etc. In terms of drug application dosage forms, it is mainly used in tablets, capsules, suspension dosage forms, pills and paste dosage forms.
Character: White powder, odorless. Insoluble in water or ethanol, soluble in dilute inorganic acids or sodium hydroxide solutions,etc.
Chemical formula : Al(OH)₃
Molecular weight : 78.004
CAS NO.: 21645-51-2
EINECS NO.: 244-492-7
Dried aluminum hydroxide gel is a typical and common antacid, which has effects such as acid resistance, suction, local hemostasis, and protection of the ulcer surface. Dried aluminum hydroxide gel reacts with the gastric acid existed in the stomach to neutralize or buffer it. However, dried aluminum hydroxide gel has no direct effect on the secretion of gastric acid, and its anti acid effect is slow and long-lasting. Dried aluminum hydroxide gel is also mixed with gastric juice to form gel, which covers the ulcer surface to form a protective film for a physical isolation and protection. Dried aluminum hydroxide gel plays a role of carrier in gel plaster formulations, and uses its special molecular structure and properties to slowly release effective ingredients to achieve the purpose of lasting efficacy. In addition, due to the combination of aluminum ions with phosphate in the intestine to form insoluble aluminum phosphate, which is excreted from the feces. Therefore, high doses of dried aluminum hydroxide gel taken by uremic patients can reduce the absorption of intestinal phosphate, thereby alleviating acidemia.
In terms of drug application dosage forms, dried aluminum hydroxide gel is mainly used in tablet, capsule, suspension dosage forms, pill, and patch dosage forms.
Inspection items | Inspection Standards | Internal Standardes |
Appearance | White powder, odorless,amorphous powder | White powder, odorless,amorphous powder |
Acid-neutralizing capacity | ≥25.0 | >29.0 |
Alkali Carbonate | ≤0.1 | ≤0.1 |
Sulfate | ≤0.6 | ≤0.6 |
Chloride | ≤0.85 | ≤0.2 |
Mercury Cadmium | ≤0.0002% | ≤0.0002% |
Heavy Metals | ≤60 | ≤10 |
Arsenic | ≤8 | ≤4 |
pH | 4.0%suspension pH≤10 | <9 |
Assay | Based on AI(OH)₃≥76.5 | ≥79 |
Microbiological Test | ||
1)Total Viable count | Not more than 10³cfu/g | ≤800cfu/g |
2)Yeast & Mold | Not more than 10²cfu/g | ≤80cfu/g |
3)E.Coli | Negative | Negative |