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DICOM SANAQ® ML 011

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

Chemical Name: Cellulose, Microcrystalline, Lactose, Anhydrous

Functions: Binder, Diluent

Dosage Form: Orally Disintegrating Tablets (ODTs), Tablets

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), GMP, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Technical Data Sheet
  • TypeDocument Name
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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Composition
  • MCC - Lactose

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
Typical Properties
ValueUnitsTest Method / Conditions
Compressibility Index17.91%
PSD (Malvern mastersizer) D(10)34.3
PSD (Malvern mastersizer) D(50)252
PSD (Malvern mastersizer) D(90)579
Residue on Ignition0.52
Physico-Chemical Properties
ValueUnitsTest Method / Conditions
Loss on Dryingmax. 3.0%USP/NF / JP / Ph. EUR
Hausner Ratio1.2
Bulk Density0.5 – 1.0g/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
Particle Size Distribution
ValueUnitsTest Method / Conditions
Particle Size250 - 600μmMalvem Method

Regulatory & Compliance