METHOCEL™ K4M Premium HPMC

1 of 65 products in this brand
METHOCEL™ K4M Premium HPMC utilized in ceramics and pharmaceuticals, serves as a binder, film former, gelling agent, mucoadhesive, solubilizer, and suspension aid. It aids in granulation and exhibits water solubility.

Functions: Binder, Controlled Release Agent, Film Former, Gelling Agent, Mucoadhesive, Solubilizer, Suspending Agent, Thickener, Viscosity Modifier

Manufacturing Technology: Granulation, Tablet Coating

Dosage Form: 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
pH (at 2%)5 - 8-Current USP/EP/JP
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%Current USP/JP
Propylene Chlorohydrins Content*max. 0.1mg/kgE464
Apparent Viscosity (at 20°C, 2% in water)2,663 - 4,970mPa.sCurrent USP/EP/JP Brookfield
Apparent Viscosity (target)3550mPa.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 Content8 - 10%Current USP/EP/JP
Methoxyl Content22 - 24%Current USP/EP/JP
Residual Solvents
ValueUnitsTest Method / Conditions
Dipropylene Glycol Contentmax. 0.1%-
Dipropylene Glycol Monomethyl Ether Contentmax. 0.1%-
Propylene Glycol Contentmax. 0.1%-
Tripropylene Glycol 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
Screen Test
ValueUnitsTest Method / Conditions
Particle Size (maximum 63 µm, through 230 U.S.STD. sieve)50 - 80%PSM 100669
Particle Size (maximum 149 µm, through 100 U.S.STD. sieve)min. 90%PSM 100669
Particle Size (maximum 420 µm, through 40U.S.STD. sieve)min. 99%PSM 100669
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