METHOCEL™ K100M Premium CR HPMC

1 of 65 products in this brand
METHOCEL™ K100M Premium CR HPMC is utilized in suspension dosage forms and serves as a binder in ceramic industrial applications. It carries labeling claims of being caffeine-free, colorant-free, dioxin-free, dye-free, and hormone-free. With manufacturing methods such as granulation and tablet coating, it exhibits water solubility.

Functions: Binder, Controlled Release Agent, Film Former, Gelling Agent, Immediate Release Agent, Mucoadhesive, Solubilizer, Sustained Release Agent, Thickener, Viscosity Modifier

Manufacturing Technology: Granulation, Tablet Coating

Dosage Form: Suspension, Tablets

Certifications & Compliance Search Terms: National Formulary (NF)

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Enhanced TDS

Identification & Functionality

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
Moisture Contentmax. 5%Current USP/EP/JP
Residue on Ignitionmax. 1.5%Current USP/JP
Propylene Chlorohydrins Content*max. 0.1mg/kgE464
Apparent Viscosity (at 20°C, 2% in water)75,000 - 140,000mPa.sCurrent USP/EP/JP Brookfield
Apparent Viscosity (target)100000mPa.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 Content9.5 - 11.5%Current USP/EP/JP
Methoxyl Content22 - 24%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

Technical Details & Test Data

Nutritional Information
USA
Nutritional Information (per 100 g)
Carbohydrates (g) 0
Non-Digestible Carbohydrates (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 1.5
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Additional Nutrient Information (per 100 g)
Calories (Energy) (kcal) 0
Cholesterol (mg) 0
Total Dietary Fiber (g) 0
Soluble Fiber (g) 93.5
Insoluble Fiber (g) 0
Sugars (g) 0
Added Sugars (g) 0
Sodium (mg) 390
Chloride (mg) 610
Potassium (mg) 0
Magnesium (mg) 0
Iron (mg) 15
Zinc (mg) 0
Total Vitamin A (IU) 0
Vitamin C (mg) 0
Thiamin (mg) 0
Riboflavin (mg) 0
Vitamin D (IU) 0
Niacin (mg) 0
Vitamin B6 (mg) 0
Calcium (mg) 0
Phosphorus (mg) 0

European Union
Nutritional Information (per 100 g)
Energy

748 kJ / 187 kcal

Fat 0 g
Of which saturates 0 g
Carbohydrates 0 g
Of which sugars 0 g
Fibre 93.5 g
Protein 0 g
Salt 1.5 g

Australia & New Zealand
Nutritional Information (per 100 g)
Energy (kJ) 748
Carbohydrates (g) 0
Dietary Fibre (g) 93.5
Water (g) 5
Ash (g) (includes salt and iron) 0.4
Total Fat (g) 0
Saturated Fat (g) 0
Trans Fat (g) 0
Protein (g) 0

Packaging & Availability