Maple Biotech Pvt. Ltd.

Partially Pregelatinized Starch Manufacturer

Partially Pregelatinized Starch

Specifications

Shelf life 5 Years
Form Powder
Purity 99%min

Additional Information

Packaging Details As per client requirement

Mabitab1500 is a new partially pregelatinized maize starch designed for pharmaceutical use. It has been developed as a filler for two-piece hard gelatin capsules. Mabitab1500 is a free-flowing and self-disintegrating powder with high bulk density, making it most suitable for this application. Excellent flow properties and bulk density allow homogenous filling of capsules. It is made from native starch by simple and unique physical modification which ensures rapid disintegration and drug release. Mabitab1500 particles action is well suitable for rapid disintegration and release of the drug from the pharmaceutical preparation. Mabitab1500 is superior starch excipient over Native Starch by virtue of its flow property and disintegration property.

Applications :

  • Flow Aid
  • Direct Compression
  • Binder for Wet Granulation
  • Mabitab1500 Meets the requirements of EP, BP, USP, IP Monographs
  • Excipient of pure vegetable origin
  • No solvent used in process and free from OVI
  • Compatible with almost all active substances
  • Very Low Friability
  • Lubricant Requirement low or nil (Advantage in Drug Dissolution)
  • Acts as Disintegrant as well as Binder
  • Direct Compression Tableting
  • Superior Flow Properties ideal for Direct Compression tableting
  • Improves the Flow property of Powder Mixture
  • Low requirement of Lubricants


 
Wet Granulation : Mabitab1500 is partially soluble in cold water. It can therefore be employed as a binder-disintegrant in wet granulation, It improves hardness and disintegration time of the tablets. Use level about 15% is recommended in wet granulation tableting

Capsule Filler:  Mabitab1500 is cost-effective filler and disintegration aid for hard gelatin capsules. Its physicochemical properties (Flow Property) are well suited to the requirements of an ideal capsule filler. The Mabitab1500 production process results in an appropriate density for this application. compared to native maize starch,


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Specifications

TEST SPECIFICATIONS
Description White or almost white, fine, granular powder, practically insoluble in water, in acetone, in ethanol, in toluene, in dilute acids and in 50 g/l solution of sodium hydroxide
Identification Ph Eur, USPNF
pH 4.5 to7 ( Ph Eur, USPNF )
Residue on Ignition max 0.5% ( Ph Eur, USPNF )
Loss on Drying Max 14% ( Ph Eur, USPNF )
Heavy Metals Max. 10 ppm
Loose Bulk Density 0.50 to 0.60 g/cm3 
Tapped Bulk Density 0.60 to 0.70 g/cm3 
SULPHUR DIOXIDE Max. 50 ppm
Oxidising Substances Negative ( Ph Eur, USPNF )
Organic Volatile Impurities USP
Residual Solvent Nil
Retention on 40 mesh
Retention on 200 mesh
Max. 1%
Min. 40%
Total Aerobic Microbial Count
Total Molds and Yeast Count
max. 1000 cfu/gm ( Ph. Eur /USP)
Max. 100 cfu/gm (Ph. Eur / USP)
E. Coli Salmonella absent (Pharma Eur/ USP)
absent (Pharma Eur/ USP)





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