MOLACID® STE

Stearic Acid

(Lubricant / Pharmaceutical Excipient)

Stearic Acid
MOLACID® STE is an organic compound commonly known as Stearic Acid with the molecular formula C18H36O2. It occurs as a white or almost white, waxy, flaky crystals, white or almost white hard masses, or white or yellowish-white powder. Stearic Acid is used as a pharmaceutical excipient, primarily as a lubricant in tablet and capsule formulations, helping improve powder processing and release during manufacture.

MOLACID® STE

by Muby Chem

Stearic Acid Product

Stearic Acid

Muby Chem operates a state-of-the-art manufacturing facility that produces Stearic Acid, renowned for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

Our advanced technology ensures the production of Stearic Acid with exceptional purity and quality, making it an ideal choice for use in the pharmaceutical industry.

Applications: MOLACID® STE is an organic compound widely used as a pharmaceutical excipient in the manufacture of tablets and capsules, where it acts as a lubricant to help powders flow and release smoothly from processing equipment. In topical formulations, it may also serve as a thickening and structuring agent, contributing to the consistency and texture of creams, ointments, and lotions. Its grade and concentration are selected according to the formulation and manufacturing requirements.

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

MOLACID® STE TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS Number 57-11-4

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as hard, white or faintly yellowish, somewhat glossy and crystalline solid, or white or yellowish-white powder.
2 Identification
Test (A)
Test (B)
Test (C)
(A) Freezing Point
(B) Acid value: 194 to 212
(C) The retention times of the major peaks of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.
3 Solubility It is freely soluble in chloroform and in ether; soluble in alcohol; practically insoluble in water.
4 Residue on ignition Not more than 4 mg
5 Acidity No red colour develops.
6 Iodine value
(A) Stearic Acid 50
(B) Stearic Acid 70
(C) Stearic Acid 95
(A) Not more than 4.0
(B) Not more than 4.0
(C) Not more than 1.5
7 Color of solution The resulting liquid is not more intensely colored than Standard solution Y or Standard solution BY.
8 Acidity No red color develops.
9 Freezing point
(A) Stearic Acid 50
(B) Stearic Acid 70
(C) Stearic Acid 95
(A) 53 to 59
(B) 57 to 64
(C) 64 to 69
10 Assay
(A) Stearic Acid 50

(B) Stearic Acid 70

(C) Stearic Acid 95
(A) Not less than 40.0% and not more than 60.0% of stearic (octadecanoic) acid (C18H36O2)
(B) Not less than 60.0% and not more than 80.0% of stearic (octadecanoic) acid (C18H36O2)
(C) Not less than 90.0% of stearic (octadecanoic) acid (C18H36O2)

PACKAGING

MOLACID® STE 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 tight containers.

ACCREDITATIONS

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

Disclaimer

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