MOLHOL® MAN

Mannitol

(Sweetening Agent / Stabilizing Agent)

mannitol-ep
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-ep-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 - EP
1 Appearance It occurs as a white or almost white crystals or powder.
2 Identification
Test (A)
Test (B)
Test (C)
Test (D)
(A) Specific optical rotation: + 23 to + 25 (dried substance).
(B) Melting point.
(C) Infrared absorption spectrophotometry.
(D) Thin layer chromatography.
3 Solubility It is freely soluble in water, practically insoluble in ethanol (96%).
4 Appearance of solution The solution is clear and colourless.
5 Conductivity Not more than 20 μS/cm-1.
6 Melting point Between 165°C to 170°C.
7 Reducing sugars Not more than 0.1%.
8 Related Substances
(A) impurity A
(B) Sum of impurity B & C
(C) Unspecified impurities
(D) Total
(A) Not more than 2.0%.
(B) Not more than 2.0%.
(C) Not more than 0.10%.
(D) Not more than 2.0%.
9 Loss on drying Not more than 0.5%.
10 PSD
(A) Greater than 425 µm
(B) Greater than 150 µm
(A) Not more than 5.0%.
(B) Not more than 40.0%.
11 Assay Not less than 97.0% and not more than 102.0% (dried substances).

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

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.