MOLACID® MALE

Maleic acid

(Acidifying Agent / Formulation Aid)

maleic-acid-ep
MOLACID® MALE is an organic compound, is also known as Maleic acid. It occurs as a white or almost white crystalline powder. Maleic acid is used in the pharmaceutical industry primarily to form stable acid addition salts (maleates) with active pharmaceutical ingredients (APIs) and as an excipient, stabilizer or pH adjuster.

MOLACID® MALE

by Muby Chem

maleic-acid-ep-male

Maleic acid

Muby Chem operates a state-of-the-art manufacturing facility producing Maleic acid, known for its exceptional purity and efficacy. This compound is particularly valuable in the pharmaceutical industry.

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

Applications: MOLACID® MALE is used in the pharmaceutical industry primarily as a salt-forming agent, acidifying agent, pH adjuster and formulation aid. It may be used in tablets, capsules, powders, oral solutions and other pharmaceutical dosage forms. It may also contribute to formulation stability and compatibility by maintaining an appropriate chemical environment for certain active ingredients. It can function as a pH adjuster and acidifying agent to establish and maintain the desired acidic conditions in pharmaceutical formulations.

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

MOLACID® MALE TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 110-16-7
2 Molecular Formula C4H4O4
3 Molecular Weight 116.1 g/mol

SPECIFICATION

#TESTSPECIFICATION - EP
1 Appearance It occurs as a white or almost white, crystalline powder.
2 Identification
Test (A)
Test (B)
Test (C)
(A) The pH of the dilution is less than 2.
(B) Examine the chromatograms obtained in the test for fumaric acid.
(C) A violet pink colour develops.
3 Solubility It is freely soluble in water and in ethanol (96%).
4 Appearance of solution Solution S is clear and not more intensely coloured than reference solution Y7.
5 Fumaric acid Not more than 1.5%.
6 Iron Not more than 5 ppm.
7 Water Not more than 2.0%.
8 Sulfated ash Not more than 0.1%.
9 Assay Not less than 99.0% and not more than the equivalent of 101.0% of (Z)-butenedioic acid, calculated with reference to the anhydrous substance.

PACKAGING

MOLACID® MALE is packed in HDPE bag or HDPE drum with double PE liners inside having bar-coded label and tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in tight glass containers.

ACCREDITATIONS

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

Disclaimer

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