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Typical Properties
Physical and Chemical Properties
- A white or nearly white, hygroscopic Free flowing powder, odorless.
- 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.
Chemical Description:
Product name: Crospovidone
CAS NO.: 9003-39-8
INCI Name: Polyvinylpolypyrrolidone (abbr. PVP-P)
APPLICATION
- As a water insoluble and super disintegrating agent,
it can be used in direct compression or wet granulation in concentrations between 2 – 5 %.
It can quickly show high capillary activity and excellent hydration without formation of gel. - It aids in short disintegration time with high dissolution in tablets.
It provides strong stability with low friability and high hardness in tablets. - Used as dry adhesives, fillers and excipients for tablets, capsules and granules.
- Improves the content uniformity of tablets.
- Used as suspension stabilizer, increase the suspension stability of oral liquid preparation.
- Widely used in food industry as a filter aid in production of wine, beer and fruit juice as PVPP and Polyphenol can form stable complexes.
- Used as a dissolution accelerator which an increase the solubility of insoluble drugs.
PACKING AND STORAGE
- All grades of Crospovidone complies to USP-NF/Ph Eur./IP/BP.
- Packed in 20 kg fibre or 30 kg plastic drum, inner lined with double polyethylene bag.
- Store in dry place at room temperature.
SPECIFICATION
|
PRODUCT |
PARTICAL SIZE (UM) |
NVP (PPM) |
PEROXIDES |
WATER-SOLUBLE (%) |
ELEMENTAL IMPURITY COMPLIANCE |
|
Crospovidone XL |
70-110 |
≤ 5.0 |
≤400 |
≤ 1.0 |
ICH Q3D |
|
Crospovidone XL-10 |
20-40 |
≤ 5.0 |
≤400 |
≤ 1.0 |
ICH Q3D |
|
Crospovidone XL LP |
70-110 |
≤ 5.0 |
≤30 |
≤ 0.5 |
ICH Q3D |
|
Crospovidone XL-10LP |
20-40 |
≤ 5.0 |
≤50 |
≤ 0.5 |
ICH Q3D |
|
Crospovidone SL |
5-20 |
≤ 10.0 |
≤400 |
≤ 0.5 |
ICH Q3D |