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LUMULSE* PEG 600 NF/FCC

LUMULSE* PEG 600 NF/FCC

Polyethylene Glycol 600 

INCI PEG-12
CAS# 25322-68-3


Purity you can rely on. Supply you can trust.

Unlock performance and formulation flexibility with LUMULSE PEG 600 NF/FCC  – ideal for use in a wide range of pharmaceutical applications, including oral and topical drug delivery. LUMULSE PEG 600 NF/FCC has especially low impurity levels to align with the new USP Monograph requirements.

LUMULSE PEG 600 NF/FCC can help deliver solubility, batch-to-batch uniformity and stability to formulations. LUMULSE PEG 600 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 600 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
LUMULSE PEG 600NF/FCC acts as a plasticizer
and API solubilizer in softgel capsules.


✓ 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 oral liquid formulations utilize the
hydrophilic properties of low molecular weight PEGs
to enhance the solubility of therapeutic agents
and excipients.


 

 LUMULSE PEG 600 NF/FCC
SPECIFICATIONS, RESIDUAL IMPURITIES
(Rev 10/17/25)

EG, %

NMT 0.062
DEG, % NMT 0.10
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

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