Crospovidone Granules are pharmaceutical-grade granulated material based on cross-linked polyvinylpyrrolidone, also known as crospovidone or cross-linked PVP. Crospovidone is a synthetic, water-insoluble cross-linked homopolymer of N-vinyl-2-pyrrolidone and is used as a functional pharmaceutical excipient, particularly as a superdisintegrant in oral solid formulations. USP-NF identifies Crospovidone under the chemical description of 1-ethenyl-2-pyrrolidinone homopolymer and gives CAS Number 9003-39-8.
The granulated presentation provides a controlled physical form for pharmaceutical formulation and manufacturing applications. Depending on the manufacturing process and intended application, granule characteristics such as particle-size distribution, moisture, bulk density and flow can influence processing and formulation performance.
Crospovidone is a cross-linked homopolymer of N-vinyl-2-pyrrolidone. Unlike soluble povidone, crospovidone is water-insoluble because of its cross-linked polymer structure. USP-NF specifies that Crospovidone contains 11.0% to 12.8% nitrogen, calculated on the dried basis.
Crospovidone is also commonly described as:
The CAS Number for Crospovidone is 9003-39-8.
Crospovidone Granules provide the cross-linked polymer in a granulated physical format. The material can be considered for formulation systems where controlled excipient handling and consistent physical characteristics are required.
Potential material characteristics include:
These physical properties should be reported according to the actual SDP product specification.
Crospovidone is primarily used as a superdisintegrant. Its cross-linked structure allows it to absorb water and promote rapid breakup of suitable solid formulations.
Crospovidone is used in pharmaceutical formulation development for tablets, capsules and other oral solid dosage systems. Its performance can depend on grade, particle size, concentration, formulation composition and manufacturing process.
USP-NF identifies two types of Crospovidone based on particle size: Type A and Type B.
For SDP, the actual type should be specified only according to the product specification.
Type: Type A / Type B
Do not assign a type solely from the product name.
Particle size is particularly important for Crospovidone because USP-NF recognizes different Crospovidone types based on particle size.
For a granulated product, SDP can additionally specify:
Particle Size: [Actual SDP specification]
Where validated data are available:
D10: [Value]
D50: [Value]
D90: [Value]
These values should not be invented because the appropriate granule size depends on the specific product grade and manufacturing process.
Crospovidone is a water-insoluble cross-linked polymer. Its water-insoluble nature distinguishes it from soluble povidone and contributes to its functionality as a disintegrant. USP-NF explicitly defines Crospovidone as water-insoluble.
Crospovidone has established pharmacopeial quality requirements. These include identity, nitrogen content, pH, water/loss on drying, residue on ignition, water-soluble substances and limits for relevant impurities.
USP-NF specifies 11.0–12.8% nitrogen on the dried basis.
Published USP material specifies:
Quality control of Crospovidone can include:
USP has specifically identified peroxide and vinylpyrrolidone testing as relevant Crospovidone quality controls.
Crospovidone Granules may be considered for:
The actual use level should be established during formulation development according to the formulation composition and manufacturing process.
Crospovidone should be protected from unsuitable environmental exposure and stored in appropriate packaging. USP material specifies preservation in tight containers.
For Crospovidone Granules, the final storage conditions should follow the actual SDP product specification and packaging requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |