METHOCEL™ K100M Premium HPMC - Specialty

1 of 39 products in this brand
METHOCEL™ K100M Premium HPMC - Specialty is employed in ceramics as a binder, utilizing granulation in its manufacturing process. Within pharmaceuticals and nutraceuticals, it serves as a suspension aid, thickener, and viscosity modifier, boasting water solubility for versatile application.

Functions: Anti-Settling Agent, Binder, Controlled Release Agent, Emulsifier, Film Former, Green Strength Enhancer, Lubricant (Internal), Plasticizer, Processing Aid, Rheology Modifier, Surfactant, Thickener

Certifications & Compliance Search Terms: National Formulary (NF)

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%)5 - 8-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Moisture Content (as packaged)max. 5%Current USP/EP/JP
Residue on Ignitionmax. 1.5%Current USP/JP
Propylene Chlorohydrins Content*max. 0.1mg/kgE464
Apparent Viscosity (at 20°C, 2% in water)75,000 - 140,000mPa.sCurrent USP/EP/JP Brookfield
Apparent Viscosity (target)100mPa.s-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP NEGATIVE
Salmonella*Absent/10gCurrent USP NEGATIVE
Staphylococcus aureus*Absent/gCurrent USP NEGATIVE
Yeast and Mold Count*max. 100/gCurrent USP
Total Plate Count*max. 100/gCurrent USP
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content10 - 12%Current USP/EP/JP
Methoxyl Content22 - 24%Current USP/EP/JP
Residual Solvents
ValueUnitsTest Method / Conditions
Propylene Glycol Contentmax. 0.1%-
Dipropylene Glycol Contentmax. 0.1%-
Tripropylene Glycol Contentmax. 0.1%-
Dipropylene Glycol Monomethyl Ether Contentmax. 0.1%-
Tripropylene Glycol Monomethyl Ether Contentmax. 0.1%-
Heavy Metals
ValueUnitsTest Method / Conditions
Arsenic Content*max. 0.1mg/kgE464
Cadmium Content*max. 0.1mg/kgE464
Mercury Content*max. 0.1mg/kgE464
Lead Content*max. 0.1mg/kgE464
Note
  • PHS - All section names come under PHS
  • * Tests tagged or noted as "Audit Basis" [AB] are conducted on a frequency that is established for each test. Audit testing is justified by knowledge of the manufacturing process, process control, use of dedicated equipment and raw material specifications.

Regulatory & Compliance

Packaging & Availability