Appearance:
White, fine powder with a smooth texture. No visible foreign matter or contamination.
Identification:
Chemical name: Kaolinite (Hydrated Aluminum Silicate).
Infrared spectroscopy or X-ray diffraction can be used for identification.
Purity:
Must contain at least 90% kaolinite.
Free from toxic contaminants such as heavy metals, pathogens, and other harmful substances.
Physical Properties:
Particle Size: Fine, ensuring smooth texture suitable for pharmaceutical use.
Moisture Content: Typically less than 14% (by weight).
pH: Between 5.0 to 7.0 (in a 5% aqueous suspension).
Ash Content: Should meet the specified limit for the material.
Heavy Metals:
Lead (Pb): Less than 10 ppm.
Arsenic (As): Less than 2 ppm.
Mercury (Hg) and Cadmium (Cd): Below specified limits (usually less than 1 ppm).
Microbial Limits:
Must be free from pathogenic microorganisms.
Standard limits for Total Aerobic Microbial Count, Yeast and Mould Count, and E. coli.
Solubility:
Insoluble in water and alcohol.
Loss on Drying:
Typically, the loss on drying (moisture content) should be less than 14%.
Test for Impurities:
Free from extraneous matter, including sand, dirt, and other non-kaolinite impurities.
Storage:
Store in a cool, dry place away from moisture and direct sunlight.
Applications:
Kaolin JP is used in pharmaceutical formulations, particularly for gastrointestinal treatments (such as anti-diarrheal formulations), topical medications, and as a suspending agent in liquid formulations.
It is also used in cosmetics (e.g., face masks, powders) due to its absorbent and gentle properties on the skin.