Magnesium Stearate
Magnesium Stearate

Item specifics

color
light white powder
pharmaceutical material
lubricant

Review

Description

Magnesium Stearate

Product: Magnesium Stearate     Molecular Formula:C36H70MgO4

Property: It is white, greasy powder, hardly disolved in water, ethanol, or acther, soluble in hot water and warm ethanol. It conforms to the standard of CP 2000 Edition, BP 2005, and USP29.

Specifications:

Appearance

White fine powder

Assay(Mg)%

4.0-5.0

Chloride content %

0.25Max

Sulfates content %

0.5max

Loss of drying %

6.0max

Heavy metals %

0.001max

Arsenic mg/kg

3.0max

Stearic acid and palmitic acid %

90min

Stearic acid %

40min

Organic volatile impurited

Conform

Applications:

Used as lubricant, glidante and anti-adhereute, in the tablet and capsule.

Packing: 10kgs/bag or 10kgs/barrel

 

CERTIFICATE OF ANALYSIS

Name: Magnesium Stearate USP35-NF30 Batch Number: 20170108

Batch Size: 9000kg                Packing Size: 20kg/bag 

Certificate No.:20170108            MFG Date: January 8, 2017

Date of Release: January 10, 2017      Expiry Date: January 7th, 2019

ANALYSIS AS PER USP35-NF30.

Items of Test

Standard

Result of Test

Appearance

A very fine, light white powder, odorless

Conforms 

Identification A TO B

Conforms

Conforms 

Acidity and Alkalinity

Conforms

Conforms

Chlorides

0.1%

<0.1%

Sulphates

1.0%

<0.5%

Heavy metal(lead)

10ppm

0.12ppm

Cadmium

3ppm

0,09ppm

Nickel

5ppm

0.09ppm

Loss on drying

6.0%

4.5%

Magnesium(Mg)

4.0%-5.0%

4.7%

stearic acid and palmitic acid

90%

99.25%

Stearate acid

40%

41.0%

Total microbial count

1000CFU/GRAM

Conforms

Total mold and yeast

100CFU/GRAM

Conforms

Escherichia coli

Absent

Absent

Salmonella species

Absent

Absent

Conclusion: It meets the standard USP35-NF30.