METHOCEL™ K200 Premium CR (Low Nitrite Grade)

1 of 65 products in this brand
METHOCEL™ K200 Premium CR (Low Nitrite Grade) is a low nitrite grade of hydroxypropyl methylcellulose in powder form. It is used in the production of capsules and tablets through tablet coating and wet granulation processes. This product functions as a binder, film former, immediate release agent, and thickener in pharmaceutical and nutraceutical applications. It is also suitable for use in modified and controlled release formulations and pharmaceutical coatings.

Functions: Binder, Film Former, Immediate Release Agent, Thickener

Manufacturing Technology: Tablet Coating, Wet Granulation

Dosage Form: Capsules, Tablets

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Enhanced TDS

Identification & Functionality

Applications & Uses

Properties

Physical Form
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%)5 - 8-CURRENT USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ashmax. 1.5%CURRENT USP/EP/JP
Loss on Dryingmax. 5.0%CURRENT USP/EP/JP
Residue on Ignitionmax. 1.5%CURRENT USP/EP/JP
Nitritemax. 200μg/kgPSM 300040
Apparent Viscosity (at 20°C, 2% in water)150,000 - 280,000mPa·sCURRENT USP/EP/JP, Brookfeild
Microbiological Values
ValueUnitsTest Method / Conditions
Yeasts and Molds Countmax. 100/gCURRENT USP Total Count
Total Plate Countmax. 100/gCURRENT USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content9.5 - 11.5%CURRENT USP/EP/JP
Methoxyl Content22 - 24%CURRENT USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 3mg/kgE464
Cadmium Contentmax. 1mg/kgE464
Mercury Contentmax. 1mg/kgE464
Lead Contentmax. 2mg/kgE464
Screen Test
ValueUnitsTest Method / Conditions
Partcle Size (through 230 USS sieve, <63 micron)50.0 - 80.0%PSM 100669
Partcle Size (through 100 USS sieve, <149 micron)min. 90.0%PSM 100669
Partcle Size (through 40 USS sieve, <420 micron)min. 99.0%PSM 100669

Regulatory & Compliance