MOLACID® LACT

Lactobionic Acid

(Stabilizer / Chelating Agent)

lactobionic-acid-usp
MOLACID® LACT is an organic compound, is also known as Lactobionic Acid. It occurs as White or almost white, crystalline powder. It is used in the pharmaceutical industry as an excipient, a stabilizer and an organ preservation solution component.

MOLACID® LACT

by Muby Chem

lactobionic-acid-usp-lact

Lactobionic Acid

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

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

Applications: MOLACID® LACT is used in the pharmaceutical industry as an excipient, stabilizer, chelating agent and organ-preservation solution component. It is mainly used in sterile liquid dosage forms, including organ-preservation and tissue-preservation solutions. Depending on formulation requirements, it may also be used in specialized pharmaceutical and biopharmaceutical preparations, including oral liquid formulations and certain tablet or capsule formulations.

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

MOLACID® LACT TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 96-82-2
2 Molecular Formula C12H22O12
3 Molecular Weight 358.30 g/mol

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as White or almost white, crystalline powder with a melting point of about 125° with decomposition.
2 Identification
Test (A)
Test (B)
(A) Infrared absorption spectrophotometry.
(B) Thin-layer chromatography.
3 Solubility It is freely soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol.
4 Water Determination Not more than 5.0%.
5 Appearance of solution The sample solution is clear and not more intensely colored than the Reference solution.
6 Optical Rotation Between +23.0° to +29.0° (anhydrous substance).
7 Reducing sugars Not less than 12.8 mL of 0.05 M sodium thiosulfate VS is required, corresponding to not more than 0.2% of reducing sugars, as glucose.
8 Total ash Not more than 0.2%.
9 Assay Not less than 98.0% to not more than 102.0% on the anhydrous basis.

PACKAGING

MOLACID® LACT 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 well-closed containers.

ACCREDITATIONS

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

Disclaimer

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