METHOCEL™ K100 Premium LV DC2 HPMC

1 of 65 products in this brand
METHOCEL™ K100 Premium LV DC2 HPMC widely used in pharmaceuticals, serves as a controlled release agent and film former. Its formulation facilitates direct compression and granulation, making it suitable for various dosage forms, like suspensions and tablet coatings. Additionally, its water solubility enhances its effectiveness in diverse applications.

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

Manufacturing Technology: Direct Compression, 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% solution)5.0 - 8.0-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
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/JP
Apparent Viscosity (at 20°C, 2% in water)80 - 120mPa.sCurrent USP/EP/JP
Apparent Viscosity (target) 100mPa.s
Microbiological Values
ValueUnitsTest Method / Conditions
Escherichia coli* Absent/gCurrent USP Negative
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 Mold and Yeast
Total Aerobic Plate Count*max. 100/gCurrent USP Total Aerobic
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (Screen <63 micron, through 230 U.S. Std. Sieve)15 - 55%PSM 100669
Particle Size (Screen <105 micron, through 140 U.S. STD.Sieve)65 - 95%PSM 100669
Particle Size (Screen <149 micron, through 100 U.S. STD.Sieve)min. 90%PSM 100669
Particle Size (Screen <420 micron, through 40 U. S. Std. Sieve)min. 95%PSM 100669
Composition
ValueUnitsTest Method / Conditions
Hydroxypropoxyl Content7.5 - 9.5%Current USP/EP/JP
Methoxyl Content22.0 - 24.0%Current USP/EP/JP
Propylene Chlorohydrins*max. 0.1mg/KgPSM 102375
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
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