Glyceryl monostearate 40-55 / Mono- and Di-Glycerides USP-NF / EP grade

Glyceryl monostearate 40-55 / Mono- and Di-Glycerides USP-NF / EP grade

Category:

Products and Applications

Pharmaceutical Ingredients

Origin

China

Brand

CARDLO

Certification

Picture Name

Model

GMS40

Adding amount

  • Product Description
    • Commodity name: Glyceryl monostearate 40-55 / Mono- and Di-Glycerides USP-NF / EP grade
    • 参数: Origin: China Brand Name: CARDLO Certifications: ISO, HALAL, KOSHER, HACCP Model: E471 GMS99/DMG95
    • 原产地: China
    • 品牌名称: CARDLO
    • 型号: GMS40

    Glyceryl monostearate 40 % , Mono- and Diglycerides , Glycerol Monostearate 40-55 , Glyceryl Monostearate, USP29-NF24 , EP grade

    Product Introduction:

    USP NF Name Mono and Diglycerides
    EP Name Glycerol Monostearate 40-55 (Type I)
    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:

    GMS is mono- and diglyceride emulsifiers prepared by glycerolysis of particular fats, oils and fractionated vegetable oil fatty acids.  They also can be prepared by esterification of glycerin or propylene glycol with selected vegetable oil fatty acids.

    GMS is a glyceride with an intermediate melting point used as a lipidic vehicle and modified release agent.

    Modified release matrix former for capsule. Coating agent for taste masking. Consistency agent. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.

     

    Quality Index:

    Main Item

    Specification

    Appearance (20℃)

    Milky white/Light yellow powder

    Monoglyceride content(%)

    40-55%

     Diesters content (%)

    30-45%

     Triesters content(%)  

    5-15%

    Acid Value(mgKOH/g)

    ≤3.0

    Free Glycerin(%)

    ≤7.0

    Iodine Value(g/100g)

    ≤3.0

    Freezing Point(℃)

    50-60℃

    Water content

    <2%

    Heavy Metals(Pb/%)

    ≤0.0005

    As(%)

    ≤0.0001

     

    Function:

    • Bioavailability enhancer
    • Solubilizer
    • Emulsifier/co-emulsifier
    • Plasticizer
    • Carrier (vehicle)
    • Employment through SEDDS - self emulsifying drug delivery systems
    • Modified release matrix former for capsules, coating agent for taste masking, consistency agent

    Dosage Forms Include:

    • Oral
    • Topical 
    • Transdermal
    • Parenteral
    • Ophthalmic

    Package & Storage:

    Packing: 25 kg/bag Validity: 24 months

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