MOLACID® MALE

Maleic acid

(Buffering Agent / pH Adjuster)

maleic-acid-usp
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-usp-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 high-quality Maleic Acid, meeting the highest standards for performance and consistency.

Applications: MOLACID® MALE is primarily used as a pH adjuster, buffering agent and to form stable salts for amine-based drugs. It helps stabilize medications, improve solubility for parenteral administration, and is sometimes used in specialized drug-delivery systems, such as anticancer micelles.

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 - USP
1 Appearance It occurs as a white or almost white, crystalline powder.
2 Identification
Test (A)
Test (B)
(A) Infrared Spectroscopy.
(B) Specified test.
3 Solubility It is freely soluble in water and in alcohol, sparingly soluble in ether.
4 Residue on ignition Not more than 0.1%.
5 Limit of Iron Not more than 5 ppm.
6 Limit of Fumaric acid and Malic acid
(A) Fumaric acid
(B) Maleic acid
(A) Not more than 1.0%.
(B) Not more than 0.5%.
7 Water Determination Not more than 0.5%.
8 Microbial Contamination
(A) TAMC
(B) TYMC
(A) Not more than 103 cfu/g.
(B) Not more than 102 cfu/g.
9 Bacterial Endotoxin Not more than 0.5 IU/mg.
10 Assay Not less than 98.0 % and not more than 102.0 % on the anhydrous basis.

PACKAGING

MOLACID® MALE 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. Preserved 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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