LUMULSE* PEG 400 NF/FCC
LUMULSE* PEG 400 NF/FCC
Polyethylene Glycol 400
INCI PEG-8
CAS# 25322-68-3
Purity you can rely on. Supply you can trust.
Unlock performance and formulation flexibility with LUMULSE PEG 400 NF/FCC – ideal for use in a wide range of pharmaceutical applications, including oral and topical drug delivery. LUMULSE PEG 400 NF/FCC has especially low impurity levels to align with the new USP Monograph requirements.
LUMULSE PEG 400 NF/FCC can help deliver solubility, batch-to-batch uniformity and stability to formulations. LUMULSE PEG 400 NF/FCC meets National Formulary standards and is suitable for use in regulated pharmaceutical manufacturing. Supported by technical documentation to streamline approval processes this product is a versatile tool for any formulator. LUMULSE PEG 400 NF/FCC may be used in a wide variety of prescription (Rx) and over-the-counter (OTC) excipients and formulation types including:
✓ Liquids /Orals
✓ Liquid / Semi Solids / Soft Gel caps
✓ Solid / Tablet Coatings / Semi Solids / Topicals
Recommended Excipient Applications
✓ Solid Dosage Forms
Low molecular weight PEGs act as lubricants
and binding agents in tablet production and API
solubilizers in softgel fills. They are also used as
plasticizers in tablet film coatings facilitating a
uniform film formation.
✓ Semi-Solid Dosage Forms
High and low molecular weight PEGs are common in
cream or ointment formulations to control viscosity,
localize drug delivery site and improve stability.
Additionally, their emollient and humectant attributes
improve the sensorial profile.
✓ Liquid Dosage Forms
Suspensions or liquid formulations, such as cough
syrup, use PEGs to enhance the solubility of
therapeutic agents and excipients.
| LUMULSE PEG 400 NF/FCC SPECIFICATIONS, RESIDUAL IMPURITIES (Rev 10/17/25) |
|
|
EG, % |
NMT 0.062 |
| EG + DEG, % | NMT 0.25 |
| Residue on Ignition (Sulfated Ash), % | 0.1 Max |
| Ethylene Oxide, ppm |
≤10 |
| 1,4 – Dioxane, ppm |
≤1 |
|
ELEMENTAL IMPURITIES |
|
| Class 1 & 2a | Per USP <232> |
Application
- Pharmaceutical
Functions
- Emulsifier
Humectant
Penetration Enhancer
Solvent & Solubilizer
Viscosity Modifier