METHOCEL™ E5 Premium LV HPMC

1 of 30 products in this brand
METHOCEL™ E5 Premium LV HPMC is water-soluble and used in suspensions, granulation, and tablet coating. It functions as a binder, controlled release agent, film former, and gelling agent in pharmaceuticals and nutraceuticals, and as a binder in ceramics.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Functions: Binder, Controlled Release Agent, Emulsifier, Film Former, Film Former, Gelling Agent, Immediate Release Agent, Lubricant (Internal), Mucoadhesive, Plasticizer, Rheology Modifier, Solubilizer, Surfactant, Sustained Release Agent, Thickener, Viscosity Modifier

Dosage Form: Suspension, Tablets

Labeling Claims: APE-free, Aflatoxin-free, Allergen-free, Aluminum-free, Animal Products-free, Antibiotics-free, BSE-free, Bisphenol A-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, 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, Not Listed In California Proposition 65, 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, Residual Solvent -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, Doping-Free, 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), FFDCA, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, ISO 14001, ISO 9001, Indian Pharmacopeia, Japan Pharmacopeia (JP), 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, USDA Organic, United States Pharmacopeia (USP), 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

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,
Thickener,
Viscosity Modifier
Plastics & Elastomers Functions
Binder,
Emulsifier,
Film Former,
Lubricant (Internal),
Plasticizer,
Rheology Modifier,
Surfactant
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,
Allergen-free,
Aluminum-free,
Animal Products-free,
Antibiotics-free,
BSE-free,
Bisphenol A-free,
Caffeine Free,
Colorants-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
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,
Not Listed In California Proposition 65,
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,
Residual Solvent -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
Food Ingredients Features
Cold Water Dispersible
Materials Features
Anti-settling Properties,
Good Gelling Behaviour,
Good Thickening Properties,
Good pH Stability,
Improved Adhesion,
Non-Ionic,
Water Soluble,
Wide pH Range

Applications & Uses

Markets
Healthcare & Pharma
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
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
Organic Solvent Soluble,
Propylene Glycol Soluble,
Water Soluble
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)*5.0 - 8.0-CE-8.7
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCE-92.1
Pseudomonas aeruginosa*Absent/1gCE-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 Content*7.0 - 12.0%CE-91.25
Methanol Content (PPM, Residual Solvents)*28.0 - 30.0%CE-91.25
Sodium Chloride Content*max. 0.3%CE-15.2
Propylene Glycol*0.1%-
Dipropylene Glycol*0.1%-
Tripropylene Glycol*0.1%-
Dipropylene Glycol Monomethyl Ether*0.1%-
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-CE-91.4 According to EP
Color Evaluation*Pass-CE-91.4 According to EP
Transmittance*min. 79.0%CE-91.29
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
Apparent Viscosity*4.1 - 4.9mPa.sCE-91.9
Apparent Viscosity (Target)*4.5mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCE-93.1
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 63 micron, through 230 mesh)*min. 50%CE-91.30
Screen (< 149 micron, through 100 mesh)*min. 90%CE-91.30
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
British Pharmacopeia (BP),
CFDA Compliant (China),
Chinese Pharmacopeia (ChP),
Directive 2009/48/EC,
Doping-Free,
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),
FFDCA,
FSSC 22000,
GMP,
Generally Recognized As Safe (GRAS),
Halal,
Hazard Analysis Critical Control Point (HACCP),
ICH Q3C,
ISO 14001,
ISO 9001,
Indian Pharmacopeia,
Japan Pharmacopeia (JP),
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,
USDA Organic,
United States Pharmacopeia (USP),
cGMP
Chemical Inventories
AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NDSL (Canada),
PICCS (Phillipines),
TSCA (USA)
Quality Standards
EN ISO 9001:2015,
GMP,
ICH Q3D

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks