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Overview of Digoxin

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DSSTox_CID_2934
  • Synopsis

  • Chemistry

PharmaCompass
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US DMFs Filed

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CEP/COS Certifications

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USA (Orange Book)

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Europe

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Canada

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Australia

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South Africa

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Uploaded Dossiers

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EXCIPIENTS
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ListLIST
  • FDA
  • EDQM
Applications: Pharmasperse® 416 is a versatile drug delivery system (DDS) comprised of excipients such as mannitol. It is specifically engineered to manufacture orally dispersible powder (ODP) formulations.
Ingredient(s): Mannitol
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • FDA
  • EDQM
Applications: Capsugel’s soft gelatin capsules and technologies brings a range of formulation and commercial benefits to the pharmaceutical and dietary supplement markets.
Ingredient(s): Gelatin, Unspecified
More Info on Category: Soft Gelatin
Route of Administration (Grade): Oral; Ocular; Vaginal
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • WHO-GMP
Applications: Pharmacel® 101 is a strong binder for wet & dry granulation formulations as it ensures uniform granulation and drying processes. It also provides excellent compaction and disintegration properties.
Dosage Form: Tablet
More Info on Category: Fillers, Diluents & Binders
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP, IP
Technical Specifications: Density- Tapped density- 440 g/l, Bulk density- 280 g/l; Particle size- D10- 25 ?m, D50- 60 ?m, D90- 20 ?m; Hausner ratio-1,57
  • WHO-GMP
Applications: Ready mix Film coating system for moisture sensitive APIs
Ingredient(s): Stearic Acid
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: USP / EP / JP; Having US-DMF
Technical Specifications: Moisture barrier film coating system
  • WHO-GMP
Applications: Orally Disintegrating Tablets/Sachets, Dispersible Tablets, Sachets, Chewable Tablets, Sublingual Tablets
Ingredient(s): Crospovidone
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF, JP, and EP. US DMF Type IV filed.
Technical Specifications: Not Available
  • WHO-GMP
Applications: Orally Disintegrating Tablets (ODTs) / Sachets, Dispersible Tablets / Sachets, Chewable Tablets, Sublingual Tablets.
Ingredient(s): Crospovidone
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF, JP, and EP.
Technical Specifications: Not Available
  • WHO-GMP
Applications: Pharmacel® 102 has good flow properties enabling high speed direct compression tableting. It is a ideal choice for direct compression & dry granulation formulations and it also has some lubrication properties for smooth tableting experience.
Dosage Form: Tablet
More Info on Category: Direct Compression
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP, IP
Technical Specifications: Density- Tapped density- 440 g/l, Bulk density- 310 g/l; Particle size- D10- 40 ?m, D50- 90 ?m, D90-180 ?m; Hausner ratio-1,42
  • WHO-GMP
Applications: Primellose® croscarmellose sodium is an effective super-disintegrant ,suitable for a variety of tablet and capsule formulations. It is effective when used intragranular and/or extragranular in granular formulations.
Ingredient(s): Croscarmellose Sodium
More Info on Category: Disintegrants & Superdisintegrants
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP
Technical Specifications: Not Available
  • FDA
  • EDQM
Applications: Advantol® 300 is a directly compressible pharmaceutical excipient used to create soft chew or soft melt oral dosage forms. It is a robust system that enables rapid product development.
Ingredient(s): Mannitol
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available