METHOCEL™ VLV Premium HPMC

1 of 65 products in this brand
METHOCEL™ VLV Premium HPMC is a versatile HPMC designed to enhance manufacturing efficiencies and for various applications, including tablet coating, orally disintegrating films, drug layering and tablet binder. METHOCEL™ VLV exhibits multiple advantages including lower coating temperatures, reduced coating time, increased process capacity and reduced process cost.

Functions: Binder, Coating System, Controlled Release Agent, Film Former, Gelling Agent, Immediate Release Agent, Mucoadhesive, Solubilizer, Thickener, Viscosity Modifier

Manufacturing Technology: Tablet Coating, Wet Granulation

Dosage Form: Granules, Orally Disintegrating Films (ODFs), Tablets

Certifications & Compliance Search Terms: National Formulary (NF)

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Enhanced TDS

Identification & Functionality

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
Color (at 2% in water)max. 65APHACE-13.8
pH (at 2%)5.0 - 8.0-CE-8.7
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-CE-91.5
Sulphated Ash Content (Residue on Ignition)max. 1.5%CE-91.34
Moisture Content (Loss on Drying)max. 5.0%CE-7.1
Apparent Viscosity2.3 - 3.3mPa.sCE-91.9
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCE-92.1
Pseudomonas aeruginosa*Absent/gCE-92.1
Salmonella*Absent/10gCE-92.1
Staphlococcus aureus*Absent/gCE-92.1
Yeast and Mold Count*max. 100/gCURRENT USP
Total Plate Count*max. 100/gCURRENT USP
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content *4.0 - 7.5%CE-91.25
Methoxyl Content*27.0 - 30.0%CE-91.25
Methanol Content (Residual Solvents)*max. 3,000mg/kgPSM 101832 Class 2
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%-
Specifications
ValueUnitsTest Method / Conditions
Apparent Viscosity (target)2.8mPas
Propylene Chlorohydrins* max. 0.1mg/kg PSM 102375
Heavy Metals
ValueUnitsTest Method / Conditions
Arsenic Content*max. 1mg/kgCE-92.1
Cadmium Content*max. 1mg/kgCE-92.1
Heavy Metals (as Lead)*max. 20mg/kgCE-92.1
Mercury Content*max. 1mg/kgCE-92.1
Lead Content*max. 2mg/kgCE-92.1
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

Packaging Type