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Povidone Disintegrant

Povidone Disintegrant

CAS No.: 9003-39-8  
HS Code: 39059900
Molecular Formula: (C6H9NO)n
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Product Details ofPovidone Disintegrant

Ulanqab Kema New Material Co., Ltd. is one of the most experienced manufacturers and suppliers of povidone disintegrant in China. Please rest assured to wholesale high quality povidone disintegrant made in China here from our factory. If you have any enquiry about free sample, please feel free to email us.

 

Product Overview

 

povidone disintegrant

Povidone disintegrant (crospovidone/PVPP) is a pharmaceutical-grade superdisintegrant that serves as a critical functional excipient in tablet and capsule formulations, engineered to promote rapid disintegration and ensure efficient drug release upon contact with aqueous media. Manufactured in our GMP-certified production facility in Inner Mongolia, China, Ulanqab Kema New Material Co., Ltd. supplies povidone disintegrant that complies with USP-NF, EP, and CP pharmacopeial standards, providing pharmaceutical manufacturers worldwide with a high-purity, batch-consistent excipient for immediate-release tablets, orally disintegrating tablets (ODTs), and hard capsules. With 30 years of experience in the PVP industry, an annual production capacity exceeding 1,500 tons of PVP series products, and partnerships with over 300 customers globally, we deliver factory-direct pricing, full regulatory documentation (COA, MSDS, COO), and complimentary samples for formulation evaluation.

As a cross-linked homopolymer of N-vinyl-2-pyrrolidone, povidone disintegrant is characterized by its high capillary activity, rapid hydration capacity, and unique wicking-and-strain-recovery disintegration mechanism. Unlike conventional swelling-type disintegrants, it functions through rapid liquid uptake into the tablet matrix via capillary action, followed by mechanical strain recovery of compressed particles that generates sufficient force to fracture the tablet structure-typically achieving complete disintegration within 30 seconds to 3 minutes. This non-ionic, non-swelling mechanism makes it particularly suitable for formulations containing cationic active pharmaceutical ingredients (APIs) where pH-dependent disintegration behavior is undesirable.

 

 

Mechanism of Action

 

The disintegration efficiency of povidone disintegrant is attributed to two primary mechanisms that work synergistically:

 

1. Capillary Wicking (Rapid Liquid Uptake)

PVPP possesses high capillary activity due to its porous, cross-linked polymer structure. When a tablet containing povidone disintegrant contacts gastrointestinal fluids or dissolution media, the excipient rapidly draws liquid into the tablet matrix through capillary channels. This wicking action is significantly faster than the diffusion-based water penetration observed with conventional starch-based disintegrants.

 

2. Strain Recovery (Mechanical Disintegration)

During tableting, the crospovidone particles are compressed and deformed under pressure. Upon exposure to moisture, these particles attempt to return to their pre-compression shape, generating substantial mechanical stress within the tablet matrix. This strain-recovery force, combined with the rapid hydration pressure, exceeds the structural integrity of the tablet and causes it to fracture into fine particles-without forming a viscous gel barrier that could impede subsequent dissolution.

 

Formulation Note: Unlike croscarmellose sodium, crospovidone does not significantly swell in water. Its non-swelling, non-ionic nature makes it advantageous for formulations where gel formation or ionic interactions with APIs are a concern. Typical usage concentration ranges from 2% to 5% in tablet formulations.

 

Property:

This product is a white or milky white powder, with an odorless or slightly characteristic odor, basically tasteless, insoluble in water, alkali, acid, and organic solvents. It has hygroscopicity and water absorption. It swells after absorbing water, but does not form a gel; after absorbing water, the molecular chain stretches and the volume increases rapidly, and the expansion force can cause the tablet to disintegrate quickly.

 

Technical Specifications

 

Parameter

Specification

Test Method / Reference

Product Name

Povidone Disintegrant (Crospovidone / PVPP)

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CAS Number

9003-39-8

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HS Code

39059900

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Molecular Formula

(C6H9NO)n

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Appearance

White to creamy-white, free-flowing powder

Visual

Odor & Taste

Practically tasteless, odorless or nearly odorless

Organoleptic

Identification

Conforms (IR spectroscopy)

USP / EP

pH (1% aqueous suspension)

5.0 – 8.0

USP / EP / CP

Loss on Drying

≤ 5.0%

USP <731> / EP 2.2.32

Sulphated Ash (Residue on Ignition)

≤ 0.1%

USP / EP

Water-Soluble Substances

≤ 0.5%

USP / EP

Nitrogen Content

11.0% – 12.8%

USP / EP (Kjeldahl)

Peroxides (as H2O2)

≤ 400 ppm

USP / EP

Vinylpyrrolidinone (Impurity A)

≤ 10 ppm

USP / EP (HPLC)

Heavy Metals (as Pb)

≤ 10 ppm

USP <231> / ICH Q3D

Particle Size (Type A / Coarse)

0-63μm<85% ;63μm>15%

Laser diffraction

Particle Size (Type B / Fine)

0-63μm>85% ;63μm<15%

Laser diffraction

Settling Volume

≥ 60 mL

EP

Microbial Limits

Complies with pharmacopeial requirements

USP/ EP 

Solubility

Practically insoluble in water and common organic solvents

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Hygroscopicity

Slightly hygroscopic

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Pharmacopeial Compliance

USP-NF, EP (Crospovidonum), JP, CP

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Shelf Life

24 months (unopened, proper storage)

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Storage Conditions

Tightly closed container, cool & dry place (≤30°C), protect from humidity

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Applications in Pharmaceutical Manufacturing

 

Povidone disintegrant is widely utilized across multiple pharmaceutical dosage forms where rapid disintegration and drug release are critical to therapeutic efficacy:

Application Area

Typical Usage Level

Key Benefit

Immediate-Release Tablets

2% – 5%

Rapid tablet breakup for fast API dissolution and absorption

Orally Disintegrating Tablets (ODTs)

3% – 5%

Disintegration within seconds without water; improved patient compliance

Hard Capsules

2% – 4%

Promotes rapid content release from capsule shells in GI tract

Wet Granulation Formulations

2% – 5% (intra- and extra-granular)

Maintains disintegration efficiency after granulation processing

Direct Compression

2% – 5%

Excellent compressibility and flow; suitable for high-speed tableting

Nutraceutical & Dietary Supplement Tablets

2% – 5%

Compatible with vitamin, mineral, and herbal active blends

Chewable Tablets

1% – 3%

Fine-grade (Type B) provides smoother mouthfeel

Taste Masking Carrier

As needed

Adsorbs and masks unpleasant-tasting APIs in oral formulations


 

Company profile

 

 Ulanqab Kema New Material Co., Ltd.  factory

Ulanqab Kema New Material Co., Ltd. is located in Mengwei New Material Industrial Park, Chayouhou Banner. It was successfully registered on June 9, 2017, with a registered capital of 50 million yuan. A production line project with an annual output of 3,000 tons of vinylpyrrolidone (NVP) and 1,500 tons of polyvinylpyrrolidone (PVP: K30, K90) has been built. We are of high quality, have won unanimous praise in China, and have obtained a series of certificates such as the ISO9001 certificate. We hope to be able to go abroad to get more people's recognition.

 

Manufacturing Capabilities & Quality Assurance

 

Ulanqab Kema New Material Co., Ltd. operates a vertically integrated PVP production facility in Mengwei New Material Industrial Park, Chayouhou Banner, Inner Mongolia, China. Our manufacturing infrastructure encompasses the complete value chain from NVP (N-vinyl-2-pyrrolidone) monomer production through to finished PVP and crospovidone products, ensuring supply chain stability, cost control, and full traceability from raw material to finished excipient.

 

Capability

Details

Production Scale

Annual output: 5,000 tons NVP monomer + 1,500 tons PVP series (K30, K90, crospovidone)

Manufacturing Standards

GMP-certified production workshops; ISO 9001 quality management system

Industry Experience

30 years of expertise in PVP polymer chemistry and pharmaceutical excipient manufacturing

Customer Base

300+ satisfied customers across domestic and international pharmaceutical markets

Facility Scale

3 integrated factory sites forming a complete NVP – PVP industry chain

Registered Capital

59.58 million RMB

Quality Documentation

Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Certificate of Origin (COO) provided with every shipment

Pharmacopeial Compliance

USP-NF, EP, JP, CP monographs

Regulatory Filing

DMF registration support available for customer regulatory submissions

Sample Policy

Free evaluation samples available (typically 100g–500g) upon request

Custom Specifications

Particle size, packaging, and specific parameter requirements can be tailored to customer needs

 

We have standardized GMP production workshops and warehouses.

Packaging & Storage

 

  • Standard packaging: 20 kg cardboard drums with double polyethylene liners, palletized for export shipping.
  • Storage: Preserve in tightly closed containers, protected from light and moisture. Store in a cool, dry, well-ventilated area at temperatures not exceeding 30°C and relative humidity below 60%. Under proper storage conditions, the product maintains full quality for 24 months from the date of manufacture.

 

FAQ

 

Q: What payment terms do you accept for international orders?
A: We accept T/T (bank wire transfer), L/C (letter of credit at sight), and PayPal for sample orders. For first‑time buyers, we typically require a 30% advance payment with the balance due against the bill of lading copy. For established customers with a track record of orders, we offer more flexible payment terms including net‑30 credit arrangements subject to credit assessment.

 

Q: What is the difference between povidone disintegrant (crospovidone/PVPP) and regular povidone (PVP K30, K90)?
A: Povidone (PVP K30, K90) is a water‑soluble, linear polymer primarily used as a tablet binder and film‑former-it holds tablet ingredients together. Povidone disintegrant (crospovidone/PVPP) is a cross‑linked, water‑insoluble form of the same polymer that functions as a superdisintegrant-it causes tablets to break apart rapidly. They share the same monomer (N‑vinyl‑2‑pyrrolidone) but serve opposite functions: povidone binds; crospovidone disintegrates.

 

Q: Does crospovidone affect the hardness or friability of tablets?
A: Crospovidone has excellent compressibility and generally does not negatively impact tablet hardness when used at recommended concentrations (2–5%). In fact, due to its deformation behavior under compression, it can contribute to tablet binding to some extent while still functioning as a disintegrant. At higher concentrations, tablet hardness may slightly decrease, so formulation optimization is recommended. Tablet friability typically remains within acceptable limits (under 1%) at standard usage levels.

 

Q: How is quality controlled during production, and what happens if a batch fails to meet specifications?
A: Our quality control follows a multi‑stage approach: (1) Raw material testing-the NVP monomer, which we produce in‑house, is tested for purity and impurities before use; (2) In‑process controls-critical process parameters (temperature, pressure, reaction time) are monitored and recorded in real time; (3) Finished product testing-every batch undergoes full pharmacopeial testing before release. If a batch does not meet specifications, it is quarantined, investigated for root cause, and either reprocessed (if feasible) or destroyed. No non‑conforming product is released to customers under any circumstances.

 

We, Ulanqab Kema, want to be your best friend and partner.

 

 

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