MOLHOL® ISM

Isomalt

(Bulking Agent / Binder / Sweetening Agent)

isomalt-usp
MOLHOL® ISM is an organic compound, commonly known as Isomalt. It is widely used in the pharmaceutical industry as a filler and binder in pharmaceutical formulations include chewable tablets, medicated lozenges and orally disintegrating tablets (ODTs).

MOLHOL® ISM

by Muby Chem

isomalt-usp-ism

Isomalt

Muby Chem operates a state-of-the-art manufacturing facility that produces high-quality Isomalt, renowned for its exceptional purity and effectiveness. This versatile compound is widely used in the pharmaceutical industry for its valuable functional properties.

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

Applications: MOLHOL® ISM is mainly used in the pharma industry as a sweetener and bulking agent. It is most commonly used in lozenges, chewable tablets, and orally disintegrating tablets (ODTs) due to its good taste and low hygroscopicity. It is preferred for sugar-free, diabetic-friendly and pediatric formulations.

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

SPECIFICATION

#TESTSPECIFICATION - USP
1 Description It occurs as white or almost white powder or granules.
2 Identification
Test (A)
Test (B)
(A)Thin Layer Chromatography.
(B)The retention times of the two principal peaks of the Sample solution
correspond to those of the Standard solution, as obtained in the Assay.
3 Limit of Nickel Not more than 1 μg/g, calculated on the anhydrous basis.
4 Organic Impurities
(A)Mannitol
(B)Sorbitol
(C)Any unknown impurity
(D)Total impurities
(A) Not more than 0.5%.
(B) Not more than 0.5%.
(C) Not more than 0.5%.
(D) Not more than 2.0%.
5 Reducing Sugars Not less than 12.8 mL of 0.05 N sodium thiosulfate VS is required, corresponding to Not more than 0.3% of reducing sugars, determined on the anhydrous basis as glucose.
6 Water Determination Not more than 7.0%.
7 Conductivity Not more than 20 μS/cm.
8 Assay Not less than 98.0% and not more than 102.0%.

PACKAGING

MOLHOL® ISM is packed in HDPE bag or 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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