Magnesium Stearate, NF, BP, JP
Experience the excellence of Magnesium Stearate, NF, BP, JP, a high-quality pharmaceutical excipient utilized primarily as an anti-adherent in the production of medical capsules, tablets, and powders. This premium-grade product is essential for ensuring smooth manufacturing processes and optimal product quality.
Key Features
- Designed for use as a tablet/capsule lubricant, facilitating superior flow and reducing friction during compression and encapsulation.
- Manufactured under stringent Good Manufacturing Practices (cGMP), ensuring safety, quality, and efficacy.
- Meets specifications set by NF, BP, and JP standards, guaranteeing its suitability for pharmaceutical applications.
Specifications
| Chemical CAS Number |
557-04-0 |
| Assay (as Mg; Dried Basis) |
4.0-5.0% |
| Relative Content of Stearic Acid and Palmitic Acid |
To pass test |
| Microbial Limits |
Total Aerobic Microbial Count: 1000 cfu/g
Total Combined Molds and Yeasts Count: 500 cfu/g
Tests for Salmonella Species and Escherichia coli: Negative |
| Acidity or Alkalinity |
To pass test |
| Loss on Drying |
6.0% |
| Heavy Metals |
Lead: 10 ppm
Nickel: 5 ppm
Chloride: 0.1%
Sulfate: 0.5%
Cadmium: 3 ppm
Maximum Limits: 20 ppm |
| Residual Solvents |
To pass test |
| Chemical Category |
FDA Regulated Items |
Safety Information
| Ratings |
| Health1 |
| Flammability1 |
