METHOCEL™ K200M Premium HPMC

1 of 65 products in this brand
METHOCEL™ K200M Premium HPMC, identified as cellulose ethers and hypromellose, serves a wide array of functions across capsules, suspensions, tablets, granulation, and tablet coating applications. It acts as a binder, film former, gelling agent, mucoadhesive, solubilizer, thickener, and viscosity modifier. Notably, it is water-soluble, ensuring versatility and efficacy in formulations.

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

Manufacturing Technology: Granulation, Tablet Coating

Dosage Form: Capsules, Suspension, 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%)5.5 - 8.0Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Moisture Content (Loss on Drying, as Packaged)max. 3.0%Current USP/EP/JP
Residue on Ignitionmax. 1.5%Current USP/JP
Apparent Viscosity (at 20°C, 2% in Water)150,000 - 280,000mPa.sCurrent USP/EP/JP, Brookfield
Propylene Chlorohydrins*max. 0.1mg/kgE464
Nitrite Contentmax. 200μg/kgPSM 300040
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 Combined Mold and Yeast
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content7.0 - 12.0%Current USP/EP/JP
Methoxyl Content19.0 - 24.0%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
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 149 micron through 100 U.S. STD Sieve)min. 90.0%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

Packaging Type