MOLACID® LEU

L-Leucine

(Lubricant / Taste-masking Agent)

l-leucine-usp
MOLACID® LEU is an organic compound, is also known as L-Leucine. It occurs as white, practically odorless, tasteless crystals. It is used in the pharmaceutical industry as a functional excipient for dry powder inhalers, a nutritional active ingredient in parenteral and enteral nutrition, and a direct lubricant or taste-masking agent in solid oral dosage manufacturing.

MOLACID® LEU

by Muby Chem

l-leucine-usp-leu

L-Leucine

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

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

Applications: MOLACID® LEU is used as a nutritional ingredient in parenteral nutrition, supplied in sterile intravenous nutritional formulations. It can also support taste masking in oral powders, granules, chewable tablets, ODTs and oral suspensions to improve patient acceptability.

It may act as a lubricant or processing aid in tablets and capsules, improving powder flow and tablet ejection during manufacturing. In enteral nutrition, it is incorporated into oral nutritional powders, liquid feeds and enteral feeding preparations.

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

MOLACID® LEU TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 61-90-5
2 Molecular Formula C6H13NO2
3 Molecular Weight 131.17 g/mol

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as white, practically odorless, tasteless crystals.
2 Solubility It is sparingly soluble in water; insoluble in ether.
3 Identification
Test (A)
(A) Infrared spectroscopy.
4 Residue On Ignition Not more than 0.4%.
5 Chloride Not more than 0.05%.
6 Sulfate Not more than 0.03%.
7 Iron Not more than 30 ppm.
8 Related Compounds
(A) Individual impurities
(B) Total impurities
(A) Not more than 0.5%.
(B) Not more than 2.0%.
9 Optical Rotation Between +14.9° to +17.3°.
10 pH Between 5.5–7.0.
11 Loss On Drying Not more than 0.2%.
12 Assay Not less than 98.5% and not more than 101.5% of C6H13NO2 on the dried basis.

PACKAGING

MOLACID® LEU 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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