Glyceryl monostearate GMS 90% USP-NF / BP

Glyceryl monostearate GMS 90% USP-NF / BP

Category:

Products and Applications

Pharmaceutical Ingredients

Origin

China

Brand

CARDLO

Certification

Picture Name

Model

GMS 90 %

Adding amount

  • Product Description
    • Commodity name: Glyceryl monostearate GMS 90% USP-NF / BP
    • 参数: Origin: China Brand Name: CARDLO Certifications: FSSC, HACCP, ISO, HALAL, KOSHER,RSPO, FDA etc. Model: GMS 90%
    • 原产地: China
    • 品牌名称: CARDLO
    • 型号: GMS 90 %

    Glyceryl monostearate GMS 90% USP-NF / BP , Mono- and Di-glycerides ,Solubilizer ,Emulsifier ,Bioavailability enhancer

    Product Introduction:

    USP NF Name Mono and Diglycerides
    EP Name Glycerol Monostearate 90 (Type II)
    Preferred Substance Name (FDA) Glyceryl Monostearate
    Handbook of Pharmaceutical Excipients Glyceryl Monostearate
    Chemical description Consists of mono-, di- and triesters of palmitic (C16) and stearic (C18) acids
    CAS No. 31566-31-1/123-94-4

     

    Product Features:

    GMS90 is a saturated glycerol ester, chiefly based on stearic and palmitic, originating from hydrogenated rape seed oil. Fatty acids and glycerol are derived from vegetable sources. The monoester content is more than 90.0 %.

    GMS90 is a white to light yellow, waxy powder with a neutral and slightly fatty odour and taste.

     

    Quality Index:

    Product Name Glyceryl Monostearate
    Grade USP-NF / BP / EP
    Authorised use Excipient
    Monoglycerides ≥90.0%
    Acid value ≤3.0
    lodin value ≤3.0
    Hydroxyl value  290-330
    Saponification value 160-175
    Melting point 60-70°C
    Free Glycerin ≤3.0%
    Heavy metals ≤0.001

     

    Application:

    Glyceryl monostearate GMS 90%  is often used in formulations of pharmaceuticals.

    GMS 90%  is principally used as an emollient, co-emulsifier, solubilizer ,dispersing agent,  stabilizing agent, tablet and

    capsule lubricant , softener, consistency regulator, binding agent and retarding agent etc.

    Owing to its lipid nature as well as the availability of many different grades, Glyceryl monostearate exhibits thickening,

    emulsifying and protective properties, making it a versatile excipient across multiple applications and dosage forms.

    Typical dosage: 1-3 %.

     

    A summary of the different applications of Glyceryl monostearate in food, pharmaceutical, and cosmetic applications is outlined below:

    • Formulation stabilizer (for water-in-oil emulsions containing polar and nonpolar ingredients)

    • Dispersant for pigments in oils or solids in fats

    • Solvent and co-solvent for phospholipids, such as lecithin

    • Hot melt granulation excipient

    • Matrix former for sustained-release tablets

    • Lubricant for tablets

    • Suppository base

    • Hydrophobic agent in tablet coatings (prevents tablet sticking)

    Incidences of polymorph formation when Glyceryl monostearate is used in product formulation are an important consideration. Generally, the α-form tends to disperse easily and foams, rendering it useful as an emulsifying agent. The β-form, being more stable, is suitable for use in sustained-release matrices.

    Note that Glyceryl monostearate is not an efficient emulsifier. Its usefulness resides in the fact that it is a useful emollient and co-emulsifier. It is readily emulsified by common emulsifying agents and by the incorporation of other fatty materials into the formulation. When added to creams, Glyceryl monostearate imparts to creams smoothness, and fineness, while improving the formulation stability.

    Package & Storage:

    Glyceryl monostearate is a relatively stable and non-reactive excipient. Shelf life is assigned as 24-36 months.

    However, if stored at warm temperatures, Glyceryl monostearate is reported to increase in acid value due to the saponification (the esters react with trace amounts of water).

    The addition of an effective antioxidant, for instance, Butylated hydroxytoluene  and Propyl gallate, can mitigate this phenomenon. 

    Nevertheless, Glyceryl monostearate should be stored in a tightly-closed container and placed in a cool, dry place, away from direct heat and light.

     

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