METHOCEL™ F50 Premium LV HPMC

1 of 30 products in this brand
METHOCEL™ F50 Premium LV HPMC serves as a versatile ingredient in various industries, functioning as a binder, controlled release agent, film former, gelling agent, immediate release agent, mucoadhesive, and solubilizer. Its water solubility makes it suitable for suspensions and various manufacturing processes.

Chemical Name: Hydroxypropyl Methylcellulose

CAS Number: 9004-65-3

Dosage Form: Suspension

Labeling Claims: APE-free, Aflatoxin-free, Aluminum-free, Antibiotics-free, BSE-free, Bisphenol A-free, CMR Substances-free, Caffeine Free, Colorants-free, Dioxin-free, Dye Free, Endocrine Disruptor-free, Generally Recognized As Safe (GRAS), Glycerin-free, Halal, Hormones-free, Hypoallergenic, Kosher, Low Odor, Monosodium Glutamate (MSG)-free, Mycotoxins-free, Natural Latex Rubber-Free, Naturally Derived, Not Listed In California Proposition 65, Odor-free, PAH-free, PFAS-Free, PFOS-free, PHO (Partially Hydrogenated Oil)-Free, PVC-free, Palm Oil-free, Paraben-free, Pareve, Perfluorooctanoic Acid-free, Pesticide-free, Phthalates-free, Plant-Based, Plasticizer-free, Preservative-free, Sugar-free, TSE-free, Tributyl Tin Compounds-Free, Triphenyl Tin Compounds-Free, USP 232 Elemental Impurities Free, Vegan, Vegetarian, Zero Calorie

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Directive 2023/915/EU, Doping-Free, EU Cosmetic Regulation 1223/2009 Compliant, EU Packaging Directive (94/62/EC), 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), FEMA Compliant, GMP, Generally Recognized As Safe (GRAS), Halal, ICH Q3C, ISO 14001, JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, National Formulary (NF), Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1272/2008, Regulation (EU) No. 2022/1396, Regulation (EU) No. 231/2012, Swiss Ordinance (SR 817.023.21), United States Pharmacopeia (USP), WEEE Directive 2012/19/EU, cGMP

Manufacturing Technology: Granulation, Tablet Coating

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

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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% solution)*5.0 - 8.0-Current USP/EP/JP
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*4.0 - 7.5%Current USP/EP/JP
Methoxyl Content*27.0 - 30.0%Current USP/EP/JP
Propylene Glycol*max. 0.1%-
Dipropylene Glycol*max. 0.1%-
Tripropylene Glycol*max. 0.1%-
Dipropylene Glycol Monomethyl Ether*max. 0.1%-
Tripropylene Glycol Monomethyl Ether*max. 0.1%-
Specifications
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP Opalescence
Color Evaluation*Pass-Current EP Solution Color
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/SP
Apparent Viscosity (at 20°C, 2% in water)*40 - 60mPa.sCurrent USP/EP/JP
Apparent Viscosity (Target)*50mPa.s-
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCurrent USP/EP/JP
Screen Test
ValueUnitsTest Method / Conditions
Screen (< 420 micron, through 40 U. S. STD. Sieve)*min. 90.0%PSM 100669
Note

*PHS - All section names come under PHS
[AB] = Audit Basis

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