METHOCEL™ E15 Premium LV HPMC

1 of 30 products in this brand
METHOCEL™ E15 Premium LV HPMC is a water-soluble product used in granulation and tablet coating manufacturing. It serves as a binder in ceramics and pharmaceuticals, functioning as a binder, immediate release agent, mucoadhesive, solubilizer, and sustained release agent.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Suspension

Labeling Claims: APE-free, Aflatoxin-free, Aluminum-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, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, 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: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Doping-Free, 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), Generally Recognized As Safe (GRAS), Halal, ICH Q3C, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1272/2008, Regulation (EU) No. 2022/1396, Regulation (EU) No. 231/2012, USDA Certified, United States Pharmacopeia (USP)

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
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,
Caffeine Free,
Colorants-free,
Dioxin-free,
Dye Free,
Endocrine Disruptor-free,
Glycerin-free,
Halal,
Hormones-free,
Hypoallergenic,
Kosher,
Low Odor,
Monosodium Glutamate (MSG)-free,
Mycotoxins-free,
Natural Latex Rubber-Free,
Naturally Derived,
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

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
Manufacturing Technology
Granulation,
Tablet Coating

Properties

Physical Form
Powder
Soluble In
Water Soluble
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)*5.0 - 8.0-USP/EP/JP/CHP
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP Negative
Pseudomonas aeruginosa*Absent/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 Content*7.0 - 12.0%USP/EP/JP/CHP
Methoxyl Content*28.0 - 30.0%USP/EP/JP/CHP
Propylene Glycol*0.1%-
Dipropylene Glycol*0.1%-
Tripropylene Glycol*0.1%-
Dipropylene Glycol Monomethyl Ether*0.1%-
Tripropylene Glycol Monomethyl Ether*0.1%-
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP Opalescence
Color Evaluation*Pass-Current EP Solution Color
Identification*Pass--
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%Current USP/EP/JP
Loss on Drying*max. 5.0%USP/EP/JP/CHP
Residue on Ignition*max. 1.5%USP/SP/CHP
Apparent Viscosity (at 20°C, 2% in water)*12.0 - 18.0mPa.sUSP/EP/JP/CHP
Apparent Viscosity (Target)*15mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 10mg/KgUSP/EP/JP/CHP
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),
Doping-Free,
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),
Generally Recognized As Safe (GRAS),
Halal,
ICH Q3C,
Japan Pharmacopeia (JP),
Kosher,
National Formulary (NF),
Regulation (EU) No. 10/2011 (PIM),
Regulation (EU) No. 1272/2008,
Regulation (EU) No. 2022/1396,
Regulation (EU) No. 231/2012,
USDA Certified,
United States Pharmacopeia (USP)

Packaging & Availability

Packaging Type
Bags,
Boxes,
Drums,
Super Sacks