【Detail】
Chemical Description
◆ Product name: Crospovidone
◆ Brand name: BOVIDONE® XL & XL-10
◆ CAS NO.:9003-39-8
◆ INCI Name: Polyvinylpolypyrrolidone (abbr. PVP-P)
◆ CEP Reg. No: 2014-344
DMF Reg. No: 29013
◆ Chinese Excipient Registration No. of Crospovidone: F20170000143
Physical and Chemical properties
-- A white or nearly white, with hygroscopic flowing powder, odorless or smelly;
-- Practically insoluble in water, acid and common organic solvents, has a strong expansion performance and complexing ability with a variety of substances;
-- Popcorn structure gives it a huge specific surface area;
Typical Properties
Specification
|
Product |
Partical size（um） |
NVP（ppm） |
Peroxides（ppm） |
Water-soluble （%） |
Element Impurity |
|
BOVIDONE® XL |
70-110 |
≤10.0 |
≤400 |
≤0.5 |
Fulfil ICH Q3D |
|
BOVIDONE® XL-10 |
20-40 |
≤10.0 |
≤400 |
≤0.5 |
Fulfil ICH Q3D |
|
BOVIDONE® XL LP |
70-110 |
≤5.0 |
≤30 |
≤0.5 |
Fulfil ICH Q3D |
|
BOVIDONE® XL-10LP |
20-40 |
≤5.0 |
≤50 |
≤0.5 |
Fulfil ICH Q3D |
|
BOVIDONE® SL |
5-20 |
≤10.0 |
≤400 |
≤0.5 |
Fulfil ICH Q3D |
Applications
◆ As a water-insoluble tablet super disintegrating agent, can be used in direct tablet pressing and dry or wet tablet pressing, the concentration normally is 2-5%, can quickly show high capillary activity and excellent hydration, without the formation of gel. The disintegrating time was short, but the dissolution rate was high, and with strong stability, the hardness of the tablet was high.
◆ Used as dry adhesives, fillers and excipients for tablets, capsules and granules. The smaller size of Bovidone can reduce the partial makings in pressed tablets and improve the uniformity of tablets.
◆ Used as a dissolution accelerator, which can increase the solubility of insoluble drugs by co-evaportation.
◆ Used as suspension stabilizer, increase the suspension stability of oral liquid preparation.
◆ Widely used in the food industry as a filter aid in the production of wine, beer and
fruit juice. PVPP and polyphenol can form stable complexes.
Packing and Storage
◆ Packed in 20kg fiber or 30kg plastic drum, inner lined with double medicinal polyethylene film bag, use nitrogen purging system to keep the peroxides stable.
◆ Stored in dry place at room temperature.
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