METHOCEL™ K100M Premium CR HPMC

1 of 30 products in this brand
METHOCEL™ K100M Premium CR HPMC is utilized in suspension dosage forms and serves as a binder in ceramic industrial applications. It carries labeling claims of being caffeine-free, colorant-free, dioxin-free, dye-free, and hormone-free. With manufacturing methods such as granulation and tablet coating, it exhibits water solubility.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Suspension

Labeling Claims: APE-free, Aflatoxin-free, Allergen-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, Melamine-free, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Non-GMO, Odor-free, 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: BSE & TSE, 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, 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

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
OpalescencePass-CE-91.4 According to EP
Color EvaluationPass-CE-91.4 According to EP
pH (at 2% solution)5.0 - 8.0-CE-8.7
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-CE-91.5
Sulfated Ash Content (Residue on Ignition)max. 1.5%CE-91.34
Moisture Content (Loss on Drying)max. 5.0%CE-7.1
Viscosity (at 2%, Brookfield LVT, Sp.4, 3 rpm)75,000 - 140,000mPa.sPSM 102400
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCE-92.1
Pseudomonas aeruginosa*Absent/gCE-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 Content9.5 - 11.5%CE-91.25
Methoxyl Content22.0 - 24.0%CE-91.25
Methanol Content (PPM, Residual Solvents)*max. 3,000mg/KgPSM 101832 Class 2
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCE-93.1
Propylene Glycolmax. 0.1%-
Dipropylene Glycolmax. 0.1%-
Tripropylene Glycolmax. 0.1%-
Dipropylene Glycol Monomethyl Ethermax. 0.1%-
Tripropylene Glycol Monomethyl Ethermax. 0.1%-
Screen Test
ValueUnitsTest Method / Conditions
Screen (<63 micron, through 230 mesh)50.0 - 80.0%CE-91.30
Screen (<149 micron, through 100 mesh)min. 90.0%CE-91.30
Screen (<420 micron, through 40 mesh)min. 95%CE-91.30
Note
  • All section names come under PHS.
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • Specification limits apply to the material as packaged in the original containers. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
  • Audit Basis [AB]*

Regulatory & Compliance

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