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DICOM SANAQ® SP 206

Off white free flowing granules.

Properties

Physical Form
  • Granules
  • Solid
Pharma and Nutraceuticals Functions
Diluent

Identification

Chemical Name

Cellulose, Microcrystalline, Polyvinyl Pyrrolidone Copolymer, Silicon Dioxide, Silicon Dioxide, Colloidal , Sodium Carboxymethyl Starch; Cellulose Microcrystalline; Polyvinyl Pyrrolidone Copolymer; Silicon Dioxide; Silicon Dioxide Colloidal; Sodium Carboxymethyl Starch

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Pharmaceutical Processing

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Fillers & Diluents

Other characteristics

Brand
DiCOM SANAQ
Functions
Diluent
Dosage Form
  • Orally Disintegrating Tablets (ODTs), Tablets
  • Orally Disintegrating Tablets (ODTs)
  • Tablets
Manufacturing Technology
Direct Compression
Certifications & Compliance

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

Grade
Pharma Grade
Markets
Healthcare & Pharma
Composition

MCC - Colloidal silicon dioxide - Polyvinyl pyrrolidone - Sodium starch glycolate

Technology
Pharmaceuticals & Nutraceuticals
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

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.

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

Technical data

Table 1 of 2

4 rows
CharacteristicValueUnitMethod
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 – 8.0—USP/NF / JP / Ph. EUR

Table 2 of 2

4 rows
CharacteristicValueUnitMethod
TAMCmax. 1000CFU/gUSP/NF / JP / Ph. EUR
TYMCmax. 100CFU/gUSP/NF / JP / Ph. EUR
E. Coli, Pseudomonas AeruginosaNegative in 10 g sample—USP/NF / JP / Ph. EUR
St. Aureus, Salmonella SpeciesNegative in 10 g sample—USP/NF / JP / Ph. EUR

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