MOLHOL® MAN

Mannitol

(Sweetening Agent / Stabilizing Agent)

mannitol-usp
MOLHOL® MAN is an organic compound widely recognized as Mannitol. It is widely used as a pharmaceutical excipient and an inert ingredient that enhances drug delivery, stability and formulation performance. Its applications include serving as a sweetener and bulking agent in tablets and capsules, a stabilizer for proteins and peptides.

MOLHOL® MAN

by Muby Chem

mannitol-usp-man

Mannitol

Muby Chem operates a state-of-the-art manufacturing facility specializing in the production of high-purity Mannitol widely recognized for its effectiveness and diverse applications in the pharma industry.

Our state-of-the-art technology guarantees uniformity and consistency in Mannitol production optimizing its role as a high-performance firming agent in pharma applications.

Application: MOLHOL® MAN imparts a mild sweetness, approximately half as sweet as sucrose, with a low glycemic index. It serves as a bulking and filler agent in tablets and capsules, improving compressibility and dosage uniformity for APIs. It also helps maintain the structural integrity of proteins and peptides by preventing denaturation and aggregation. MOLHOL® MAN is used as a carrier in inhaled formulations, including bronchial challenge tests for asthma diagnosis. It is also employed in diagnostic tests to assess kidney function.

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

MOLHOL® MAN TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 69-65-8
2 Molecular Formula C6H14O6
3 Molecular Weight 182.2 g/mol

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as a white crystalline powder or free-flowing granules.
2 Identification
Test (A)
(A) Infrared spectroscopy.
3 Solubility It is freely soluble in water; slightly soluble in pyridine; very slightly soluble in. ethanol (95%); insoluble in chloroform and in ether.
4 Related Substances
(A) Sorbitol
(B) Sum of isomalt and maltitol
(C) Unspecified impurities
(D) Total impurities
(A) Not more than 2.0%.
(B) Not more than 2.0%.
(C) Not more than 0.10%.
(D) Not more than 2.0%.
5 Reducing sugars Not more than 0.1% expressed as glucose.
6 Nickel Not more than 1 μg/g.
7 Melting range or temperature Between 165°C to 170°C.
8 Appearance of solution The sample solution should be clear and colorless; its clarity is same as that of the water or its opalescence is not more pronounced than that of the reference suspension, it should not more intensely colored than the standard solution.
9 Conductivity Not more than 20 μS/cm at 25℃.
10 Loss on drying Not more than 0.5%.
11 PSD
(A) > 425 µm
(B) >150 µm
(A) Not more than 5.0%.
(B) Not more than 40.0%.
12 Assay Not less than 97.0% and not more than 102.0% of mannitol (C6H14O6), calculated on the dried basis.

PACKAGING

MOLHOL® MAN 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 container.

ACCREDITATIONS

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

Disclaimer

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