MOLHOL® LACT

Lactitol

(Excipient / Laxative)

lactitol-bp
MOLHOL® LACT is an organic compound with the molecular formula C12H24O11. H2O, commonly known as Lactitol. It is widely used in the pharmaceutical industry as an excipient in pharmaceutical formulations include oral powders, syrups/solutions, granules and chewable tablets.

MOLHOL® LACT

by Muby Chem

lactitol-bp-lact

Lactitol

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

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

Application: MOLHOL® LACT is used in pharmaceutical formulations as a diluent and sweetening agent in tablets, powders, and syrups. It acts as an osmotic laxative in constipation and hepatic encephalopathy preparations. It is also used in sugar-free and diabetic-friendly formulations due to its low caloric value and low glycemic effect.

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

MOLHOL® LACT TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 81025-04-9
2 Molecular Formula C12H24O11. H2O
3 Molecular Weight 362.3 g/mol

SPECIFICATION

#TESTSPECIFICATION - BP
1 Appearance It occurs as white or almost white, crystalline powder.
2 Identification
Test (A)
Test (B)
Test (C)
(A) Specific Optical rotation. +13.5 to +15.5.
(B) Infrared absorption spectrophotometry.
(C) Thin layer chromatography.
3 Solubility Very soluble in water, slightly soluble to very slightly soluble in ethanol (96 %), practically insoluble in methylene chloride.
4 Appearance of solution Solution is clear and not more intensely colored than reference solution BY7.
5 Acidity or alkalinity Not more than 0.3 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.
6 Specific Optical rotation +13.5 to +15.5.
7 Related Substances-
(A) Impurity B
(B)Total of other Impurities
(A) Not more than 1.0 %.
(B) Not more than 1.0 %.
8 Reducing Sugars Not more than 0.2 %.
9 Water 4.5% to 5.5 %.
10 Sulphated Ash Not more than 0.1 %.
11 Assay Not less than 96.5 % and not more than 102.0 % (anhydrous Substance).

PACKAGING

MOLHOL® LACT 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

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