Download Brochure

MOLPOLOX™ 407

Poloxamer 407

(Thermoreversible Gel Former / Sustained Drug Release)

Poloxamer 407
MOLPOLOX™ 407 is an organic compound, widely known as Poloxamer 407. It is a nonionic block copolymer widely used in pharmaceutical and ophthalmic formulations as a thermoreversible gel-forming agent, surfactant, solubilizer, stabilizer, and emulsifier.

MOLPOLOX™ 407

Poloxamer 407

Poloxamer 407

Muby Chem operates a state-of-the-art manufacturing facility producing Poloxamer 407 with high purity and consistent quality suitable for pharmaceutical and ophthalmic applications.

Our advanced manufacturing technology ensures the production of high-quality Poloxamer 407 meeting stringent pharmaceutical quality standards for performance and consistency. MOLPOLOX™ 407 is widely used in ophthalmic gels and eye drops.

Application: MOLPOLOX™ 407 exhibits thermoreversible gelation, forming gels at body temperature. This characteristic helps improve retention time on the ocular surface and supports sustained-release ophthalmic formulations. It is widely used in ophthalmic gels, eye drops, ocular lubricants and in situ gelling systems. Additionally, it functions as a solubilizer, stabilizer, surfactant and lubricant, helping improve formulation stability and patient comfort in ophthalmic preparations.

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

SPECIFICATION

# TEST SPECIFICATION - BP
1 Appearance It occurs as white or almost white, waxy powder, microbeads or flakes.
2 Identification
Test (A)
Test (B)
Test (C)
(A) Infrared absorption spectrophotometry.
(B) Average relative molecular mass.
(C) Oxypropylene: oxyethylene ratio.
3 Solubility It is very soluble in water and in ethanol (96.0%), practically insoluble in light petroleum (bp: 50-70 °C)
4 Appearance of solution Solution is not more intensely coloured than reference solution BY7.
5 Melting point About 50°C
6 pH 5.0 to 7.5
7 Ethylene oxide, propylene oxide and dioxan
(A) Ethylene oxide
(B) Propylene oxide
(C) Dioxan
(A) Not more than 1 ppm
(B) Not more than 5 ppm
(C) Not more than 10 ppm
8 Average relative molecular mass 9840 to 14600
9 Oxypropylene: oxyethylene ratio Not less than 71.5% and not more than 74.9%
10 Water Not more than 1.0%
11 Microbial contamination
(A) TAMC
(B) TYMC
(A) Not more than 103 cfu/g
(B) Not more than 102 cfu/g
12 BET Not more than 5 IU/mg
13 Total ash Not more than 0.4%

PACKAGING

MOLPOLOX™ 407 is packed in HDPE bag or HDPE drum with double PE liners inside and is provided with a barcoded label and a tamper-evident seal.

SHELF LIFE, STORAGE AND PACKING

The shelf life is 3 years. Preserve in tight containers.

ACCREDITATIONS

GMP
GLP
FDCA
FDA
FSSAI
FSSC
HALAL
STAR KOSHER
FAMI QS
ISO

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.