METHOCEL™ A15 Premium LV Methylcellulose - Specialty

1 of 40 products in this brand
METHOCEL™ A15 Premium LV Methylcellulose - Specialty a versatile water-soluble excipient, is used in granulation, tablet coating, and wet granulation processes. It is employed in drug delivery solutions for oral healthcare and in industrial applications for ceramics and refractory materials. It functions as a binder, disintegrant, emulsifier, and stabilizer.

Functions: Anti-Settling Agent, Binder, Controlled Release Agent, Emulsifier, Film Former, Green Strength Enhancer, Lubricant (Internal), Plasticizer, Processing Aid, Rheology Modifier, Surfactant

Chemical Name: Methylcellulose

Chemical Family: Cellulose & Cellulosics, Cellulose Ethers

End Uses: Ceramics

Dosage Form: Tablets

Certifications & Compliance: British Pharmacopeia (BP), CFDA Compliant (China), Chinese Pharmacopeia (ChP), Directive 1333/2008/EC, Directive 2009/48/EC, Doping-Free, EC No. 1935/2004, EC No. 2023/2006, EU Directive 2002/72/EC, EU Packaging Directive (94/62/EC), EXCiPACT, European Pharmacopeia (Ph. Eur.), European Regulation 396/2005/EC, FCC Compliant, FDA 21 CFR 101.9, FDA 21 CFR 172.874, FDA 21 CFR 182.1480, FDA Compliant, FDA Food Safety Modernization Act (FSMA), FFDCA, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ICH Q3C, IFANCA Halal, ISO 14001, ISO 9001, Indian Pharmacopeia, Japan Pharmacopeia (JP), National Formulary (NF), Organic Certified, Orthodox Union Kosher, Regulation (EC) No. 1333/2008, Regulation (EU) No. 10/2011 (PIM), Regulation (EU) No. 1169/2011, Regulation (EU) No. 1272/2008, Regulation (EU) No. 1829/2003, Regulation (EU) No. 1830/2003, Regulation (EU) No. 2022/1396, Regulation (EU) No. 231/2012, USDA Organic, United States Pharmacopeia (USP), cGMP

Features: Anti-settling Properties, Cold Water Dispersible, Good Gelling Behaviour, Good Thickening Properties, Good pH Stability, High Cohesion, Improved Adhesion, Improved Dispersion, Low Ash Content, Low Surface Tension, Non-Ionic, Non-Toxic, Thixotropic, Water Soluble, Wide pH Range

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Enhanced TDS

Identification & Functionality

Features & Benefits

Applications & Uses

Properties

Soluble In
Physical Properties
ValueUnitsTest Method / Conditions
pH (at 2% solution)*5.0 - 8.0-Current USP/EP/JP
Typical Properties
ValueUnitsTest Method / Conditions
Opalescence*Pass-Current EP
Color Evaluation*Pass-Current EP
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)*2024-12-18mPa.sCurrent USP/EP/JP
Microbiological Values
ValueUnitsTest Method / Conditions
E. coli*Absent/gCurrent USP
Pseudomonas aeruginosa*Absent/gCurrent USP
Salmonella*Absent/10gCurrent USP
Staphylococcus aureus*Absent/gCurrent USP
Yeast and Mold Count*max. 100/gCurrent USP
Total Plate Count*max. 100/gCurrent USP
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size (Eqpc D90)*max. 260μmPSM 102627
Particle Size (Eqpc D50)*40 - 90μmPSM 102627
Particle Size (Eqpc D10)*min. 8μmPSM 102627
Composition
ValueUnitsTest Method / Conditions
Methoxyl Content*27.5 - 31.5%Current USP/EP/JP
Heavy Metals
ValueUnitsTest Method / Conditions
Heavy Metals (as Lead)*max. 20mg/KgCurrent USP/EP/JP
Note
  • PHS - All section names come under PHS
  • *[AB]

Regulatory & Compliance

Technical Details & Test Data

Nutritional Infromation
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