METHOCEL™ K15M Premium CR HPMC

1 of 29 products in this brand
METHOCEL™ K15M Premium CR HPMC suitable for ceramics and pharmaceuticals, functions as a binder and enables controlled release in suspensions and tablet coatings. Its water solubility enhances efficacy, and it serves as a film former, gelling agent, and mucoadhesive, broadening its utility.

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: ABNT NBR 14725, 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

  • TypeDocument Name
  • Brochure

    IFF Pharma Solutions Portfolio Brochure

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  • Brochure

    METHOCEL™ Cellulose Ethers Brochure

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
OpalescencePass-Current EP
Color Evaluation (solution Color)Pass-Current EP
pH (at 2% solution)5.0 - 8.0-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-Current USP/EP/JP
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Moisture Content (Loss on Drying)max. 5.0%Current USP/EP/JP
Residue on Ignitionmax. 1.5%Current USP/JP
Apparent Viscosity (at 20°C, Brookfield, 2% in water)13,275 - 24,780mPa.sCurrent USP/EP/JP
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP/EP/JP
Pseudomonas aeruginosaAbsent/1gCurrent USP
Salmonella*Absent/10gCurrent USP
Staphylococcus aureus*Absent/1gCurrent USP
Yeast and Mold Count (Total)*max. 100/gCurrent USP
Total Plate Count*max. 100/gCurrent USP
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content9.5 - 10.5%Current USP/EP/JP
Methoxyl Content22.0 - 24.0%Current USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCurrent USP/EP/JP
Screen Test
ValueUnitsTest Method / Conditions
Screen (<63 micron, through 230 U.S. STD.Sieve)50.0 - 80.0%PSM 100669
Screen (<149 micron, through 100 U.S.STD.Sieve)min. 90.0%PSM 100669
Screen (<420 micron, through 40 U.S.STD.Sieve)min. 99.0%PSM 100669
Note
  • PHS - All section names come under PHS
  • *[AB]

Regulatory & Compliance

Technical Details & Test Data

Nutritional Infromation
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