MOLHOL® MGL

Meglumine

(Solubilizing Agent / pH-Adjusting Agent / Stabilizer)

meglumine-ep
MOLHOL® MGL is an organic compound widely recognized as Meglumine. It is widely used as a multifunctional pharmaceutical excipient. MOLHOL® MGL is primarily used as a solubilizing agent, pH-adjusting agent, stabilizer and counter-ion in pharmaceutical formulations

MOLHOL® MGL

by Muby Chem

meglumine-ep-mgl

Meglumine

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

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

Application: MOLHOL® MGL is widely used as a solubilizing, pH-adjusting, stabilizing and counter-ion agent in pharmaceutical formulations, including oral solutions, tablets, capsules, injectable preparations, topical formulations and other suitable dosage forms. It is particularly useful for improving the aqueous solubility of poorly water-soluble acidic active pharmaceutical ingredients through salt formation or ionization. MOLHOL® MGL can also be used to adjust formulation pH and support the chemical and physical stability of pharmaceutical preparations.

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

MOLHOL® MGL TYPICAL PROPERTIES

#PROPERTYTYPICAL VALUE
1 CAS No 6284-40-8
2 Molecular Formula C7H17NO5
3 Molecular Weight 195.2 g/mol

SPECIFICATION

#TESTSPECIFICATION - EP
1 Appearance It occurs as a white or almost white, crystalline powder.
2 Identification
Test (A)
(A) Infrared absorption spectrophotometry.
3 Solubility It is freely soluble in water, sparingly soluble in ethanol (96%), practically insoluble in methylene chloride.
4 Melting point About 128°C.
5 Appearance of solution The solution is clear and colourless.
6 Specific optical rotation Between -17.0 to -16.0 (dried substance).
7 Reducing substances Not more than 0.2%.
8 Chlorides Not more than 100 ppm.
9 Sulfates Not more than 150 ppm.
10 Aluminium Not more than 5 ppm.
11 Iron Not more than 10 ppm.
12 Loss on drying Not more than 0.5%.
13 Sulfated ash Not more than 0.1%.
14 Assay Not less than 99.0% and not more than 101.0% (dried substances).

PACKAGING

MOLHOL® MGL 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

This document and any information provided herein does not constitute a legally binding obligation of Muby Chem and has been prepared in good faith and is believed to be accurate as of the date of issuance. Unless expressly agreed otherwise in writing in a supply contract or other written agreement between you and Muby Chem:

  1. To the fullest extent not prohibited by the applicable laws, MUBY CHEM EXPRESSLY DISCLAIMS ALL REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, BY FACT OR LAW, INCLUDING ANY IMPLIED WARRANTIES, REPRESENTATIONS OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, NON-INFRINGEMENT, AND ANY REPRESENTATIONS, WARRANTIES, CONDITIONS OR GUARANTEES, ARISING FROM STATUTE, COURSE OF DEALING OR USAGE OF TRADE AND MUBY CHEM HEREBY EXPRESSLY EXCLUDES AND DISCLAIMS. ANY LIABILITY RESULTING FROM OR IN CONNECTION WITH THIS DOCUMENT OR ANY INFORMATION PROVIDED HEREIN, including, without limitation, any liability for any direct, consequential, special, or punitive damages relating to or arising therefrom, except in cases of (i) death or personal injury, (ii) Muby Chem or its agents and assistants willful misconduct, fraud or fraudulent misrepresentation or (iii) any matter in respect of which it would be unlawful for Muby Chem to exclude or restrict liability under the applicable laws;
  2. Any information provided herein can be changed at Muby Chem sole discretion anytime and neither this document nor the information provided herein may be relied upon to satisfy any obligations you may have to undertake your own inspections and evaluation.
  3. Muby Chem rejects any obligation to, and will not, automatically update this document and any information provided herein, unless required by applicable law; and
  4. You are responsible for confirming that you have retrieved the most current version of this document from Muby Chem.