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Manus Aktteva Biopharma LLP offers partially pregelatinized starch, as per USP, BP specifications with Drug master file, DMF for your evaluation, pilots and commercial requirements with supportive technical package required for evaluation
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Partially Pregelatinized starch
Partially Pregelatinized starch
Manus Aktteva Biopharma LLP offers partially pregelatinized starch, as per USP, BP specifications with Drug master file, DMF for your evaluation, pilots and commercial requirements with supportive technical package required for evaluation.
Product Reference MA-RZ-694
Appearance White to yellowish white coarse powder
Solubility Insoluble in water & ethanol
Identification A reddish violet to blue color is produced with iodine solution
pH of 10 % solution 4.50 – 7.00
Iron NMT 20 ppm.
Oxidizing Substances Absent
Sulphur dioxide NMT 0.005 %
Foreign Matter Confirms as per USP
Loss on Drying NMT 14.00 %
Sulphated Ash 0.50 Max.
Microbial Limit
Total Bacterial Count: NMT 1000 cfu/gm
Total Fungal Count : NMT 100 cfu/gm
Salmonella : Absent
E. coli : Absent
Pregelatinized Starch is a starch produced from native starch by chemical or mechanical processing to rupture all or part of granules in presence of water and subsequently dried. Excipents are increasingly being recognized for the critical role they play in pharmaceutical products.

In formulation, pharmaceutical excipients contribute enormously to the efficacy of a product. They bind tablets together under stress of direct compression, control the release of active ingredients, help tablets disintegrate and dissolve efficiently and influence absorption.

Pregelatinized starches for all pharmaceutical forms developed by the formulator and produced/marketed by pharmaceutical manufacturers, e.g., for clinical or medical applications, have to comply with the described manufacturing definition and furthermore, must meet the quality criteria of the relevant monograph.

Pregelatinised starch can be provided as a fully or partially pregelatinised starch excipients.

Pregelatinised starch brings a number of benefits both in processing and performance. They enhance flow and compressibility and can be used as binders in direct compression as well as wet granulation. High purity pregelatinised starch excipients have a number of advantages in use. They allow simplified processes as they swell in cold water and therefore reduce time/cost compared with traditional starch paste preparation.

Fully pregelatinised starch excipients swell rapidly in water to develop strong binding properties in wet granulation processes. They agglomerate powders most efficiently into granules with good flow and compression characteristics.

Fully pregelatinised starch is extremely soluble in cold water, eliminating the need to prepare heated starch paste for wet granulation applications. By eliminating this pre-solubilisation step, the starch can be added directly to granulation equipment with other actives and excipients. Water can be used as the granulation fluid. Partially pregelatinised starches at 10 – 20 % soluble fraction have ideal granular characteristics to serve as a direct compressible excipients. With a bulk density of approximately 0.55 – 0.56 gm/ml as compared with fully pregelatinised non-agglomerated starches with approximately 0.53 mg/ml, they can provide both excellent direct tableting and wet granulation binding performance.

Pregelatinised starch is a moderate to fine powder, white to off-white in colour, is odourless and has a slight, characteristic taste. It is insoluble in cold water and in alcohol. It is used as a tablet binder, tablet and/or capsule diluent, and also as a tablet disintegrant.
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