METHOCEL™ K3 Premium LV HPMC

1 of 30 products in this brand
METHOCEL™ K3 Premium LV HPMC utilized in ceramics and pharmaceuticals, serves as a binder, controlled release agent, film former, gelling agent, immediate release agent, and mucoadhesive, facilitating suspension and tablet coating. Its water solubility adds versatility in various applications.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Functions: Binder, Controlled Release Agent, Film Former, Gelling Agent, Immediate Release Agent, Mucoadhesive, Solubilizer, Sustained Release Agent, Viscosity Modifier

Dosage Form: Suspension, 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, Odor-free, 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 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. 2022/1396, 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

Technical Data SheetSafety Data SheetBrochure
  • TypeDocument Name

  • Brochure

    IFF Pharma Solutions Portfolio Brochure

    View

  • Brochure

    METHOCEL™ Cellulose Ethers Brochure

    View

View All Documents

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,
Immediate Release Agent,
Mucoadhesive,
Solubilizer,
Sustained Release Agent,
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,
Odor-free,
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
Healthcare & Pharma — Other Healthcare & Pharma Applications
Segments
Dietary Supplement,
Pharmaceutical
Applications
Pharmaceutical — Immediate release
Dietary Supplement — Immediate release
Dosage Form
Suspension,
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 aeruginosaAbsent/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 Content7.0 - 12.0%Current USP/EP/JP
Methoxyl Content19.0 - 24.0%Current USP/EP/JP
Specifications
ValueUnitsTest Method / Conditions
OpalescencePass-Current EP Opalescence
Color EvaluationPass-Current EP Solution Color
pH (at 2% solution)5.5 - 8.0-Current USP/EP/JP
IdentificationPass-Current USP/EP/JP
Residual SolventPass-Current USP/EP/JP
Sulfated Ash Contentmax. 1.5%Current USPIEP/SP
Moisture Content (Loss on Drying)max. 5.0%Current USPIEP/SP
Residue on Ignitionmax. 1.5%Current USP/SP
Apparent Viscosity (at 20°C, 2% in water)*2.4 - 3.6mPa.sCurrent USP/EP/JP
Apparent Viscosity (Target)3mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)max. 20mg/Kg-
Note

*PHS - All section names come under PHS
[AB] = Audit Basis

Regulatory & Compliance

Certifications & Compliance
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
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. 2022/1396,
Regulation (EU) No. 231/2012,
Swiss Ordinance (SR 817.023.21),
USDA Organic,
United States Pharmacopeia (USP),
WEEE Directive 2012/19/EU,
cGMP
Chemical Inventories
IECSC (China)
Quality Standards
EN ISO 9001:2015,
GMP,
ICH Q3D

Technical Details & Test Data

Nutritional Information
USA
Nutritional Information (per 100 g)
Carbohydrates (g) 0
Non-Digestible Carbohydrates (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 1.5
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

 

Additional Nutrient Information (per 100 g)
Calories (Energy) (kcal) 0
Cholesterol (mg) 0
Total Dietary Fiber (g) 0
Soluble Fiber (g) 93.5
Insoluble Fiber (g) 0
Sugars (g) 0
Added Sugars (g) 0
Sodium (mg) 390
Chloride (mg) 610
Potassium (mg) 0
Magnesium (mg) 0
Iron (mg) 15
Zinc (mg) 0
Total Vitamin A (IU) 0
Vitamin C (mg) 0
Thiamin (mg) 0
Riboflavin (mg) 0
Vitamin D (IU) 0
Niacin (mg) 0
Vitamin B6 (mg) 0
Calcium (mg) 0
Phosphorus (mg) 0

 

European Union
Nutritional Information (per 100 g)
Energy

748 kJ / 187 kcal
Fat 0 g
Of which saturates 0 g
Carbohydrates 0 g
Of which sugars 0 g
Fibre 93.5 g
Protein 0 g
Salt 1.5 g

 

Australia & New Zealand
Nutritional Information (per 100 g)
Energy (kJ) 748
Carbohydrates (g) 0
Dietary Fibre (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 0.4
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks