METHOCEL™ K100M Premium HPMC

1 of 30 products in this brand
METHOCEL™ K100M Premium HPMC 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.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Labeling Claims: APE-free, Aflatoxin-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, CMR Substances-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Generally Recognized As Safe (GRAS), Glycerin-free, Halal, Hormones-free, Hypoallergenic, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Non-GMO, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Pareve, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plant-Based, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), 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 172.874, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FEMA Compliant, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, National Bioengineered Food Disclosure Standard, National Formulary (NF), Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1272/2008, Regulation (EU) No. 231/2012, Swiss Ordinance (SR 817.023.21), United States Pharmacopeia (USP), WEEE Directive 2012/19/EU, cGMP

Manufacturing Technology: Granulation

Synonyms: Hydroxypropyl methyl cellulose ether, Methyl hydroxypropyl cellulose, Cellulose hydroxypropyl methyl ether, 2-Hydroxypropyl methyl cellulose, 2-Hydroxypropyl methyl cellulose ether, Hydroxypropyl methyl cellulose, HPMC, Hypermellose, Hypromellose

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
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