METHOCEL™ K100M Premium HPMC - Specialty

1 of 38 products in this brand
METHOCEL™ K100M Premium HPMC - Specialty is employed in ceramics as a binder, utilizing granulation in its manufacturing process. Within pharmaceuticals and nutraceuticals, it serves as a suspension aid, thickener, and viscosity modifier, boasting water solubility for versatile application.

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

End Uses: Ceramics

Dosage Form: Tablets

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Directive 1333/2008/EC, Directive 2009/48/EC, Directive 2023/915/EU, Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EU Packaging Directive (94/62/EC), EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR 101.9, FDA 21 CFR 172.874, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FEMA Compliant, FFDCA, 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, JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, National Bioengineered Food Disclosure Standard, 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. 1272/2008, 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), WEEE Directive 2012/19/EU, 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
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCE-92.1
Pseudomonas aeruginosa*Absent/1gCE-92.1
Salmonella*Absent/10gCE-92.1
Staphylococcus aureus*Absent/gCE-92.1
Yeast and Mold Count*max. 100/gCE-92.1
Total Plate Count*max. 100/gCE-92.1
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content*7.0 - 12.0%CE-91.25
Methoxyl Content*19.0 - 24.0%CE-91.25
Methanol Content (PPM, Residual Solvents)max. 3,000mg/KgPSM 101832
Propylene Glycol*0.1%-
Dipropylene Glycol*0.1%-
Tripropylene Glycol*0.1%-
Dipropylene Glycol Monomethyl Ether*0.1%-
Tripropylene Glycol Monomethyl Ether*0.1%-
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP Opalescence
Color Evaluation*Pass-Current EP Solution Color
pH (at 2% solution)*5.0 - 8.0-Current USP/EP/JP
Identification*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%CE-91.34
Moisture Content (Loss on Drying)*max. 5.0%CE-7.1
Viscosity (Brookfield, at 2%)*75,000 - 140,000mPa.sPSM 102400
Viscosity (Brookfield, at 2%, Target)*100000mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCE-93.1
Note

*NF and Ph. Eur. ID tests; “A” and “B” on a quarterly basis. ID tests “C” (NF and Ph. Eur.) and “D” (Ph.Eur.) will be completed by exception only.

Regulatory & Compliance

Packaging & Availability