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DICOM SANAQ® SR 300

1 of 6 products in this brand
Off white free flowing granules.

Chemical Name: Cellulose, Microcrystalline, Ethylcellulose, Hydroxypropyl Methylcellulose, Low-Substituted Hydroxypropyl Cellulose, Magnesium Stearate, Silicon Dioxide, Silicon Dioxide, Colloidal , Talc

Functions: Matrix Forming Agent

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Dosage Form: Orally Disintegrating Tablets (ODTs), Tablets

  • TypeDocument Name
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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Composition
  • Hydroxypropyl Methylcellulose
  • EC - MCC - HPC - Starch -Colloidal Silicon dioxide -Talcum - Mg Stearate"

Features & Benefits

Product Highlights
  • Mixtures with high compressibility,superior diluition properties and fast disitegrating time. The purpose of the excipient is to aid processing during manufacture, enhance stability or bioavailability.

Applications & Uses

Manufacturing Technology
Application Fields

LS 004

Diluent - Disintegrant

 

ML 011

 

Diluent - Binder

 

SP 204

Designed for moisture sensitive APIs and where alkaline conditions are needed for stability purpose

 

SP 205

Designed for moisture sensitive and low bulk density and fluffy API’s formulations.

 

SP 206

Designed for moisture sensitive and low bulk density and fluffy API’s formulations

SR 300

Designed for modified release, matrix type of tablets

 

Properties

Physical Form
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 3.0%USP/NF / JP / Ph. EUR
Bulk Density0.75g/mLUSP/NF / JP / Ph. EUR
Repose Anglemax. 35°USP/NF / JP / Ph. EUR
pH Value (2% Aqueous Suspension)4.0 – 8.0USP/NF / JP / Ph. EUR
Microbiological Values
ValueUnitsTest Method / Conditions
TAMCmax. 1000CFU/gUSP/NF / JP / Ph. EUR
TYMCmax. 100CFU/gUSP/NF / JP / Ph. EUR
E. Coli, Pseudomonas AeruginosaNegative in 10 g sampleUSP/NF / JP / Ph. EUR
St. Aureus, Salmonella SpeciesNegative in 10 g sampleUSP/NF / JP / Ph. EUR

Regulatory & Compliance