Dried Aluminum Hydroxide Gel
Dried Aluminum Hydroxide Gel

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.

Inspection report:

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 powderWhite 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