METHOCEL™ K4M Premium HPMC

1 of 29 products in this brand
METHOCEL™ K4M Premium HPMC utilized in ceramics and pharmaceuticals, serves as a binder, film former, gelling agent, mucoadhesive, solubilizer, and suspension aid. It aids in granulation and exhibits water solubility.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

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

Dosage Form: Tablets

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, Irradiation-free, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Nitrosamines-free, Non-GMO, Organic, 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, Sewage Sludge Free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, USP 232 Elemental Impurities Free, VOC-free, Vegan, Vegetarian, Zero Calorie

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, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ISO 14001, ISO 9001, Indian Pharmacopeia, JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, 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

Manufacturing Technology: Granulation, Tablet Coating

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

Chemical Family
Cellulose & Cellulosics,
Cellulose Ethers
Chemical Name
Hydroxypropyl Methylcellulose
Ingredient Origin
Plant Origin
Pharma & Nutraceuticals Functions
Binder,
Controlled Release Agent,
Film Former,
Gelling Agent,
Mucoadhesive,
Solubilizer,
Suspending Agent,
Thickener,
Viscosity Modifier
Technologies
Pharmaceuticals & Nutraceuticals
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Emulsifiers & Stabilizers,
Formulation & Processing Aids,
Modified & Controlled Release,
Pharmaceutical Coatings,
Solvents & Solubilizers

Features & Benefits

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,
Irradiation-free,
Kosher,
Low Odor,
Monosodium Glutamate (MSG)-free,
Mycotoxins-free,
Natural Latex Rubber-Free,
Naturally Derived,
Nitrosamines-free,
Non-GMO,
Organic,
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,
Sewage Sludge Free,
Sugar-free,
TSE-free,
Tributyl Tin Compounds-Free,
Triphenyl Tin Compounds-Free,
USP 232 Elemental Impurities Free,
VOC-free,
Vegan,
Vegetarian,
Zero Calorie

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments
Dietary Supplement,
Pharmaceutical
Applications
Dietary Supplement — Controlled release
Pharmaceutical — Controlled release
Dosage Form
Tablets
Manufacturing Technology
Granulation,
Tablet Coating

Properties

Physical Form
Powder
Soluble In
Water Soluble
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP Negative
Pseudomonas aeruginosa*Absent/1gCurrent USP Negative
Salmonella*Absent/10gCurrent USP Negative
Staphylococcus aureus*Absent/gCurrent USP Negative
Yeast and Mold Count*max. 100/gCurrent USP Total Count
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content*min. 8.1%Current USP/EP/JP
Methoxyl Content*19.0 - 24.0%Current USP/EP/JP
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
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%Current USP/EP/JP
Moisture Content (Loss on Drying)*max. 5.0%Current USP/EP/JP
Residue on Ignition*max. 1.5%Current USP/EP/JP
Apparent Viscosity (at 20°C, 2% in water)*2,663 - 4,970mPa.sCurrent USP/EP/JP
Apparent Viscosity (Target)3550mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCurrent USP/EP/JP
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

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,
FSSC 22000,
GMP,
Generally Recognized As Safe (GRAS),
Halal,
ICH Q3C,
ISO 14001,
ISO 9001,
Indian Pharmacopeia,
JECFA (FAO/WHO),
Japan Pharmacopeia (JP),
Kosher,
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
Quality Standards
EN ISO 9001:2015,
GMP,
ICH Q3D

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks