METOLOSE® SR 90SH-100000SR

Other characteristics

Brand

METOLOSE

Functions

Binder, Controlled Release Agent, Sustained Release Agent

Dosage Form

Tablets

Labeling Claims

BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; BSE-free; Kosher; Non-GMO; Solvent-free; TSE-free

Certifications & Compliance

DMF Type IV, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Generally Recognized As Safe (GRAS), JECFA (FAO/WHO), Japan Pharmacopeia (JP), Kosher, The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)

Note

*Values in the table are viscosities of 2 w/w % aqueous solution at 20°C

Grade

Pharma Grade

Markets

Healthcare & Pharma

PACKAGE

Packaging material

Double-layered polyethylene bag in fiber drum

Net weight

Depending on grades

Storage

Keep dry. Store away from excess heat and sunlight. Store in sealed containers.

Features

For Hydrophilic matrix formulation of API and METOLOSE® SR to extend the dissolution. The dosage forms can be obtained by direct compression or granulation process.; METOLOSE® SR has specifications of particle size which can be suitable for sustained release application.; Dissolution profile can be easily adjusted by selecting appropriate grade.; Recommendable amount of METOLOSE® SR is more than 20% in the formulation in order to form the stable gel layer.

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Technology

Pharmaceuticals & Nutraceuticals

Packaging Type

• Bags
• Drums
• Totes (IBC)

Manufacturing Technology

• Direct Compression
• Granulation
• Tablet Coating

Certifications and Compliance

DMF Type IV; European Pharmacopeia (Ph. Eur.); FDA Compliant; GMP; Generally Recognized As Safe (GRAS); JECFA (FAO/WHO); Japan Pharmacopeia (JP); Kosher; The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA); United States Pharmacopeia (USP)