METHOCEL™ E10M Premium CR HPMC

1 of 65 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.

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

Manufacturing Technology: Granulation, Tablet Coating, Wet Granulation

Dosage Form: Capsules, Suspension, Tablets

Certifications & Compliance Search Terms: National Formulary (NF)

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Physical Form
Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2%)5 - 8-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Sulfated Ash Contentmax. 1.5%Current USP/EP/JP
Residue on Ignitionmax. 1.5%Current USP/JP
Moisture Contentmax. 5%Current USP/EP/JP
Propylene Chlorohydrins Content*max. 0.1mg/kgE464
Apparent Viscosity (at 20°C, 2% in water)9,525 - 17,780mPa.sCurrent USP/EP/JP Brookfield
Apparent Viscosity (target)12700mPa.s-
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP NEGATIVE
Salmonella*Absent/10gCurrent USP NEGATIVE
Staphylococcus aureus*Absent/gCurrent USP NEGATIVE
Yeast and Mold Count*max. 100/gCurrent USP
Total Plate Count*max. 100/gCurrent USP
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content8.5 - 10.5%Current USP/EP/JP
Methoxyl Content28 - 30%Current USP/EP/JP
Residual Solvents
ValueUnitsTest Method / Conditions
Propylene Glycol Contentmax. 0.1%-
Dipropylene Glycol Contentmax. 0.1%-
Tripropylene Glycol Contentmax. 0.1%-
Dipropylene Glycol Monomethyl Ether Contentmax. 0.1%-
Tripropylene Glycol Monomethyl Ether Contentmax. 0.1%-
Heavy Metals
ValueUnitsTest Method / Conditions
Arsenic Content*max. 0.1mg/kgE464
Cadmium Content*max. 0.1mg/kgE464
Mercury Content*max. 0.1mg/kgE464
Lead Content*max. 0.1mg/kgE464
Screen Test
ValueUnitsTest Method / Conditions
Particle Size (maximum 63 µm, through 230 U.S.STD. sieve)50 - 80%PSM 100669
Particle Size (maximum 149 µm, through 100 U.S.STD. sieve)min. 90%PSM 100669
Particle Size (maximum 420 µm, through 40U.S.STD. sieve)min. 99%PSM 100669
Note
  • PHS - All section names come under PHS
  • * Tests tagged or noted as "Audit Basis" [AB] are conducted on a frequency that is established for each test. Audit testing is justified by knowledge of the manufacturing process, process control, use of dedicated equipment and raw material specifications.

Regulatory & Compliance

Packaging & Availability