METHOCEL™ K100 Premium LV DC2 HPMC

1 of 30 products in this brand
METHOCEL™ K100 Premium LV DC2 HPMC widely used in pharmaceuticals, serves as a controlled release agent and film former. Its formulation facilitates direct compression and granulation, making it suitable for various dosage forms, like suspensions and tablet coatings. Additionally, its water solubility enhances its effectiveness in diverse applications.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Functions: Binder, Controlled Release Agent, Film Former, Flow Promoter, 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, 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, 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: Direct Compression, 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,
Flow Promoter,
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,
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
Suspension,
Tablets
Manufacturing Technology
Direct Compression,
Granulation,
Tablet Coating

Properties

Physical Form
Powder
Soluble In
Water Soluble
Physical Properties
ValueUnitsTest Method / Conditions
OpalescencePass-Current EP Opalescence
Color EvaluationPass-Current EP Solution Color
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/EP/JP
Apparent Viscosity (at 20°C, 2% in water)80 - 120mPa.sCurrent USP/EP/JP
Microbiological Values
ValueUnitsTest Method / Conditions
E. Coli (D=2.55S⁻¹)*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP
Salmonella*Absent/10gCurrent USP
Staphylococcus aureus*Absent/gCurrent USP
Yeast and Mold Count*max. 100/gCurrent USP
Total Aerobic Plate Count*max. 100/gCurrent USP
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (Screen <63 micron, through 230 U.S. Std. Sieve)15 - 60%PSM 100669
Particle Size (Screen <105 micron, through 140 U.S. STD.Sieve)65 - 95%PSM 100669
Particle Size (Screen <149 micron, through 100 U.S. STD.Sieve)min. 90%PSM 100669
Particle Size (Screen <420 micron, through 40 U. S. Std. Sieve)min. 95%PSM 100669
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content7.5 - 9.5%Current USP/EP/JP
Methoxyl Content22.0 - 24.0%Current USP/EP/JP
Propylene Chlorohydrins*max. 0.1mg/KgPSM 102375
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (As Lead)*max. 20mg/KgCurrent USP/EP/JP
Note

* - Audit Basis (AB)
PHS - All section names come under PHS

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,
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
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