METHOCEL™ K4M Premium HPMC

1 of 50 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.

INCI Name: Methylcellulose

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Tablets

Ingredient Origin: Plant Origin

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Enhanced TDS

Identification & Functionality

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

Applications & Uses

Markets
Healthcare & Pharma,
Personal Care
Applications
Personal Care — Beauty & Care
Oral Care
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Segments
Dietary Supplement,
Pharmaceutical
Applications
Dietary Supplement — Controlled release
Pharmaceutical — Controlled release
Application Format
Rinse Off
Dosage Form
Tablets
Manufacturing Technology
Granulation,
Tablet Coating
Oral Care Applications
Mouthwash,
Toothpaste

Properties

Physical Form
Powder
Soluble In
Cold Water Soluble,
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 Search Terms
National Formulary (NF)
Chemical Inventories
AIIC (Australia),
CSCL (Japan),
DSL (Canada),
EINECS (EU),
ENCS (Japan),
ISHL (Japan),
KECI (Korea),
METI (Japan),
PICCS (Phillipines)
Quality Standards
EN ISO 9001:2015,
GMP,
ICH Q3D

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks