JRS PHARMA VIVAPHARM® PVP, PVP/VA and PVPP Excipients
A family of water-soluble povidone and copovidone grades and water-insoluble crospovidone grades with different K-values, specification limits and particle-size profiles.
PVP K25, K30 and K90 are water-soluble povidone grades distinguished mainly by K-value.- PVP/VA 64 is a water-soluble copovidone containing a controlled vinyl acetate component.
- PVPP XL and PVPP XL-10 are water-insoluble crospovidone grades.
- PVPP XL is Type A with a coarser particle-size profile.
- PVPP XL-10 is Type B with a finer particle-size profile.
- All six grades are not classified as hazardous.
- The grades have shared microbiological requirements and broad compendial coverage.
Compares the particle-size profiles that distinguish PVPP XL from PVPP XL-10.
| PVPP Particle-Size | ||
|---|---|---|
| Parameter | PVPP XL | PVPP XL-10 |
| d10 | 15-50 µm | 6-15 µm |
| d50 | 60-140 µm | 20-40 µm |
| d90 | 200-300 µm | 50-80 µm |
| Sieve residue through 63 µm | Min. 15% | Max. 15% |
| Particle size < 38 µm (400 Mesh) | Max. 50% | Not stated |
Presents the acceptance criteria shared across all six grades.
| Microbiological Requirements | |
|---|---|
| Parameter | Acceptance criteria |
| TAMC | Max. 10² cfu/g |
| TYMC | Max. 20 cfu/g |
| E. coli | Absent in 1 g |
| Pseudomonas aeruginosa | Absent in 1 g |
| Salmonella species | Absent in 10 g |
| Staphylococcus aureus | Absent in 1 g |
| Salmonella species | Absent in 1 g |
Compares the pharmacopoeial and food-additive references associated with each grade.
| Compendial Coverage | |
|---|---|
| Grade | Compendial references |
| PVP K25 | Ph. Eur., USP, JP, ChP and E 1201 |
| PVP K30 | Ph. Eur., USP, JP, ChP, E 1201 and FCC |
| PVP K90 | Ph. Eur., USP, JP, ChP, E 1201 and FCC |
| PVP/VA 64 | Ph. Eur., NF, JP, ChP, E 1208 and FCC |
| PVPP XL | Ph. Eur., NF, JP, ChP, E 1202 and FCC |
| PVPP XL-10 | Ph. Eur., NF, JP, ChP, E 1202 and FCC |
Provides a standalone material overview for each grade.
VIVAPHARM® PVP K25
Povidone supplied as a white or off-white hygroscopic powder or flakes. It is freely soluble in water, methanol and ethanol, very slightly soluble in acetone and practically insoluble in ether. Nominal K-value: 25.
VIVAPHARM® PVP K30
Povidone supplied as a white or off-white hygroscopic powder or flakes. It is freely soluble in water, methanol and ethanol, very slightly soluble in acetone and practically insoluble in ether. Nominal K-value: 30.
VIVAPHARM® PVP K90
Povidone supplied as a white or off-white hygroscopic powder or flakes. It is freely soluble in water, methanol and ethanol, very slightly soluble in acetone and practically insoluble in ether. Nominal K-value: 90.
VIVAPHARM® PVP/VA 64
Copovidone supplied as a white or off-white hygroscopic powder or flakes. It is freely soluble in water, methylene chloride, methanol and ethanol and practically insoluble in diethyl ether. Nominal K-value: 28.
VIVAPHARM® PVPP XL
Type A crospovidone supplied as a white or off-white hygroscopic powder or flakes. It is practically insoluble in water, methylene chloride and ethanol.
VIVAPHARM® PVPP XL-10
Type B crospovidone supplied as a white or off-white hygroscopic powder or flakes. It is practically insoluble in water, methylene chloride and ethanol.
Provides the structured properties used in product-family comparisons.
| Grade Properties | ||||
|---|---|---|---|---|
| Grade | Material | pH | Water solubility | Storage temperature |
| PVP K25 | Povidone | 3.0-5.0 | Soluble | No specific limit stated |
| PVP K30 | Povidone | 3.0-4.5 | Soluble | Do not exceed 50°C |
| PVP K90 | Povidone | 4.0-7.0 | Soluble | No specific limit stated |
| PVP/VA 64 | Copovidone | 3.0-7.0 | Soluble | No specific limit stated |
| PVPP XL | Polyvinylpolypyrrolidone | 5.0-8.0 | Insoluble | Do not exceed 50°C |
| PVPP XL-10 | Polyvinylpolypyrrolidone | 5.0-8.0 | Insoluble | Do not exceed 50°C |
Focuses on the specification values most useful for distinguishing the grades. Shared routine parameters are not repeated.
| Key Grade Differences | |||
|---|---|---|---|
| Grade | Assay, as Nitrogen | K-value | Selected specification |
| PVP K25 | 12.0-12.8% | 24.0-27.0 | 2-Pyrrolidone: Max. 3.0% |
| PVP K30 | 12.0-12.8% | 29.0-32.0 | 2-Pyrrolidone: Max. 2.0% |
| PVP K90 | 12.0-12.8% | 85.0-95.0 | 2-Pyrrolidone: Max. 1.0%; Triethanolamine: Max. 1.5% |
| PVP/VA 64 | 7.0-8.0% | 25.2-30.8 | Vinyl acetate component: 35.3-41.4% |
| PVPP XL | 11.0-12.8% | Not applicable | Sieve residue through 63 µm: Min. 15% |
| PVPP XL-10 | 11.0-12.8% | Not applicable | Sieve residue through 63 µm: Max. 15% |
Covers hazard status, dust controls, incompatibilities, and shared storage requirements.
Safety and Storage
- None of the grades is classified as hazardous or requires hazard labelling.
- Dust may cause respiratory irritation.
- Avoid dust generation and provide adequate workplace ventilation.
- Accumulated fine dust may create an explosion hazard.
- Spilled material may create a slipping hazard.
- Use dust-protection goggles and respiratory protection when required.
- Protect from humidity, UV radiation, and sunlight.
- Keep away from strong oxidizing and reducing agents.
- Storage class 11: combustible solids.
- Storage stability is at least three years.
- PVP K30, PVPP XL, and PVPP XL-10 must not be exposed to temperatures above 50°C.
Summarizes biodegradability, water-hazard, environmental, and transport information across the range.
Environmental and Transport Information
- PVP/VA 64 is not readily biodegradable according to OECD criteria.
- PVP K30 and PVP/VA 64 are slightly hazardous to water and classified as WGK 1.
- No indication of bioaccumulation potential is reported for any grade.
- None of the grades meets the PBT or vPvB criteria.
- Prevent uncontrolled release into drains, surface water, or the environment.
- None of the grades is regulated as dangerous goods for transport.
Summarizes residual-solvent and elemental-impurity controls relevant to quality review.
Quality Notes
- PVP K25, K30 and K90 list formic acid as the residual solvent likely to be present, controlled below 0.5%.
- PVP/VA 64 lists acetic acid and ethanol, controlled below 0.5%.
- PVPP XL and PVPP XL-10 list acetic acid and formic acid, controlled below 0.5%.
- ICH Q3D elements are not used in manufacturing and are not analysed per batch.
- Detailed elemental-impurity information is available on request.