METHOCEL™ K100 Premium LV HPMC

1 of 50 products in this brand
METHOCEL™ K100 Premium LV HPMC is used in suspensions and as a binder in ceramics. It's manufactured using granulation and tablet coating processes. In pharmaceuticals and nutraceuticals, it serves as an immediate release agent and mucoadhesive due to its water-soluble nature.

INCI Name: Methylcellulose

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Suspension, Tablets

Ingredient Origin: Plant Origin

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Enhanced TDS

Identification & Functionality

Applications & Uses

Properties

Physical Form
Soluble In
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*8.0 - 10.0%Current USP/EP/JP
Methoxyl Content*22.0 - 24.0%Current USP/EP/JP
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
pH (at 2% solution)*5.0 - 8.0-Current USP/EP/JP
Identification*Pass-Current USP/EP/JP
Residual Solvent*Pass-Current USP/EP/JP
Sulfated Ash Content*max. 1.5%Current USP/EP/JP
Moisture Content (Loss on Drying)*max. 5.0%Current USP/EP/JP
Residue on Ignition*max. 1.5%Current USP/EP/JP
Apparent Viscosity (at 20°C, 2% in water)*80 - 120mPa.sCurrent USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 10mg/KgCurrent USP/EP/JP
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 63 micron, through 230 U.S.STD. Sieve)*45.0 - 65.0%PSM 100669
Screen (< 149 micron, through 100 U.S. STD.Sieve)*min. 90.0%PSM 100669
Screen (< 420 micron, through 40 U. S. STD. Sieve)*min. 99.0%PSM 100669
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

Packaging & Availability