MOLSTEAR® MAG

Magnesium Stearate

(Stabilizer / Binding Agent)

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MOLSTEAR® MAG is a white or almost white, very fine, light powder. It is widely recognized as Magnesium Stearate. MOLSTEAR® MAG commonly used in the pharmaceutical industry to ensure tablets are smooth, consistent and easy to swallow.

MOLSTEAR® MAG

by Muby Chem

magnesium-stearate-product-usp

Magnesium Stearate

Muby Chem operates a state-of-the-art manufacturing facility producing Magnesium Stearate known for its exceptional purity and efficacy. This compound is valuable in the pharmaceutical application.

Our advanced technology ensures uniformity and consistency in the formulation of Magnesium Stearate, making it a reliable and effective binding agent.

Applications: MOLSTEAR® MAG is primarily used as a lubricant and anti-sticking agent in tablets, capsules, granules and other solid oral dosage forms. During tablet compression, it reduces friction between the formulation and the tablet tooling, helping prevent sticking and picking and supporting smooth tablet ejection. It can also improve powder flow and facilitate consistent manufacturing.

We follow Good Manufacturing Practices (GMP) and adhere to international regulatory standards to ensure quality consistency with continuous supply.

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as a very fine, light, white powder, slippery to touch.
2 Identification
Test (A)
Test (B)
(A) It gives a reaction of Magnesium.
(B) Examine the chromatograms.
3 Solubility It is insoluble in water, in alcohol and in ether.
4 Chloride Not more than 0.1%.
5 Sulfate Not more than 1.0%.
6 Limit of Cadmium Not more than 3 ppm.
7 Limit of Lead Not more than 10 ppm.
8 Limit of Nickel Not more than 5 ppm.
9 Acidity or Alkalinity Not more than 0.05 mL of 0.1 N hydrochloric acid or 0.1 N sodium hydroxide is required to change the color of the indicator.
10 Specific surface area Specified test.
11 Relative content of stearic acid and palmitic acid
(A) Stearic acid
(B) Sum of stearic acid and palmitic acid in the fatty acid fraction
(A) Not less than 40.0%.
(B) Not less than 90.0%.
12 Assay
(A) Magnesium
(A) Not less than 4.0% and not more than 5.0% on the dried basis.

PACKAGING

MOLSTEAR® MAG is packed in HDPE bag or HDPE drum with double PE liners inside and is provided with a barcoded label and a tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in a tightly closed container.

ACCREDITATIONS

fda
health canada
edqm1
edqm
sgs
ANVISA
sfda
saphra
tga
china
mhra
cdsco
who
eu
exci
ecovadis

Disclaimer

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