METHOCEL™ E10M Premium CR HPMC

1 of 30 products in this brand
METHOCEL™ E10M Premium CR HPMC is a versatile product with various applications and functions. Ideal for tablet coating, granulation, wet granulation, tablets, and capsules, it ensures controlled and immediate release. Free from sewage sludge, it serves as a thickener, solubilizer, viscosity modifier, binder, film former, gelling agent, and mucoadhesive, making it indispensable in pharmaceutical and nutraceutical formulations. Suitable for food containers and packaging, it boasts water solubility, ensuring quality performance in suspension formulations.

Chemical Name: Hydroxypropyl Methylcellulose, Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Capsules, Suspension, Tablets

Labeling Claims: APE-free, Allergen-free, Aluminum-free, Antibiotics-free, Artificial Flavor-Free, Bactericide-free, Bisphenol A-free, CMR Substances-free, Caffeine Free, Colorants-free, Diethylene Glycol-free, Dioxin-free, Endocrine Disruptor-free, Ethylene Glycol-free, Fungicide-free, Gluten-free, Glycerin-free, Halal, Herbicide-free, Hormones-free, Impurities-free, Low Aldehyde, Low Odor, Monosodium Glutamate (MSG)-free, NPE-free, Natural Latex Rubber-Free, Naturally Derived, No Artificial Sweeteners, Odor-free, PAH-free, PFAS-Free, PFOA-free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Perfluorocarbon (PFC)-free, Pesticide-free, Phthalates-free, Plant-Based, Plasticizer-free, Potassium-free, Preservative-free, Quaternary Ammonium Salt-Free, Radioactive-free, Steroids Free, Sugar-free, Tributyltin (TBT) - Free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Directive 1333/2008/EC, 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), FFDCA, GMP, Generally Recognized As Safe (GRAS), Halal, Japan Pharmacopeia (JP), National Formulary (NF), REACH Exempt (Europe), Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 231/2012, United States Pharmacopeia (USP)

Manufacturing Technology: Granulation, Tablet Coating, Wet Granulation

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
View All Documents

Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
OpalescencePass-Current EP Opalescence
Color EvaluationPass-Current EP Solution Color
pH (at 2%)5.0 - 8.0-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Identification*Pass-Current USP/EP/JP
Residual Solvents*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)9,525 - 17,780mPa.sCurrent USP/EP/JP, Brookfield
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*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 Combined Mold and Yeast
Total Plate Count*max. 100/gCurrent USP Total Aerobic
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content8.5 - 10.5%Current USP/EP/JP
Methoxyl Content28.0 - 30.0%Current USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Lead Content*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. 95.0%PSM 100669
Screen (< 420 micron through 40 U. S. STD. Sieve)min. 99.0%PSM 100669
Note
  • The following specifications apply to sealed, unopened containers stored under the recommended conditions for the duration of the shelf life.
  • All section names come under (PHS).
  • Audit Basis*
  • 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.
  • This product is certified to contain not more than 0.1% of each of the following components: Propylene glycol, Dipropylene glycol, Tripropylene glycol, Dipropylene glycol monomethyl ether and Tripropylene glycol monomethyl ether.

Regulatory & Compliance

Packaging & Availability