METHOCEL™ K200M Premium HPMC - Specialty

1 of 40 products in this brand
METHOCEL™ K200M Premium HPMC - Specialty 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: Anti-Settling Agent, Binder, Controlled Release Agent, Emulsifier, Film Former, Green Strength Enhancer, Lubricant (Internal), Plasticizer, Processing Aid, Rheology Modifier, Surfactant, Thickener

Chemical Name: Hydroxypropyl Methylcellulose

Chemical Family: Cellulose & Cellulosics, Cellulose Ethers

Dosage Form: Tablets

Certifications & Compliance: Belgian Law And Codex Alimentarius Standards, British Pharmacopeia (BP), Chinese Pharmacopeia (ChP), Directive 1333/2008/EC, Directive 2009/48/EC, EU Packaging Directive (94/62/EC), EXCiPACT, European Pharmacopeia (Ph. Eur.), FDA 21 CFR 101.9, FDA 21 CFR 172.874, FDA 21 CFR 174.5, FDA 21 CFR 175.105, FDA 21 CFR 175.300, FDA 21 CFR 176.170, FDA 21 CFR 176.180, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FFDCA, FSC Certified, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, IFANCA Halal, ISO 14001, ISO 9001, Indian Pharmacopeia, Japan Pharmacopeia (JP), Kosher, Nagoya Compliant, National Formulary (NF), Organic Certified, Orthodox Union Kosher, Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1829/2003, Regulation (EU) No. 1830/2003, Regulation (EU) No. 231/2012, Swiss Ordinance (SR 817.023.21), USDA Organic, United States Pharmacopeia (USP), Waste Electrical & Electronic Equipment Directive (WEEE), cGMP

Features: Anti-settling Properties, Cold Water Dispersible, Good Gelling Behaviour, Good Thickening Properties, Good pH Stability, High Cohesion, Improved Adhesion, Improved Dispersion, Low Ash Content, Low Surface Tension, Non-Ionic, Non-Toxic, Thixotropic, Water Soluble, Wide pH Range

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
OpalescencePass-Current EP Opalescence
Color EvaluationPass-Current EP Solution Color
pH (at 2%)5.0 - 8.0-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-Current USP/EP/JP
Residual Solvents*Pass-Current USP/EP/JP
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Moisture Content (Loss on Drying, as Packaged)max. 5.0%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
Microbiological Values
ValueUnitsTest Method / Conditions
E. 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 Count
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
Heavy Metals
ValueUnitsTest Method / Conditions
Lead Content*max. 20mg/kgCurrent USP/EP/JP
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 149 micron through 100 U.S. STD Sieve)min. 90.0%PSM 100669
Note
  • All section names come under PHS.
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • Specification limits apply to the material as packaged in the original containers. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
  • This product is certified to contain not more than 0.1% of each of the following components: Propylene glycol, Dipropylene glycol, Tripropylene glycol, Dipropylene glycol monomethyl ether and Tripropylene glycol monomethyl ether.
  • Audit Basis*

Regulatory & Compliance

Packaging & Availability

Packaging Type