METHOCEL™ E15 Premium LV HPMC

1 of 65 products in this brand
METHOCEL™ E15 Premium LV HPMC is a water-soluble product used in granulation and tablet coating manufacturing. It serves as a binder in ceramics and pharmaceuticals, functioning as a binder, immediate release agent, mucoadhesive, solubilizer, and sustained release agent.

Functions: Binder, Controlled Release Agent, Emulsifier, Film Former, Gelling Agent, Immediate Release Agent, Lubricant (Internal), Mucoadhesive, Plasticizer, Rheology Modifier, Solubilizer, Surfactant, Sustained Release Agent, Thickener, Viscosity Modifier

Manufacturing Technology: Granulation, Tablet Coating

Dosage Form: Suspension, Tablets

Certifications & Compliance Search Terms: National Formulary (NF)

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%)5 - 8-USP/EP/JP/CHP
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Moisture Contentmax. 5%Current USP/EP/JP
Residue on Ignitionmax. 1.5%USP/JP/CHP
Water Insoluble Substancemax. 0.5%CHP
Propylene Chlorohydrins Content*max. 0.1mg/kgE464
Apparent Viscosity (at 20°C, 2% in water)12 - 18mPa.sCurrent USP/EP/JP Brookfield
Apparent Viscosity (target)15mPa.s-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP
Salmonella*Absent/10gCurrent USP
Staphylococcus aureus*Absent/gCurrent USP
Yeast and Mold Count*max. 100/gCurrent USP
Total Plate Count*max. 100/gCurrent USP
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content7 - 12%Current USP/EP/JP
Methoxyl Content28 - 30%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
Heavy Metal Contentmax. 0.1mg/kgCHP
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