Crospovidone (XL-10)

Product Overview

Super Disintegrant

Provides rapid and complete tablet disintegration for immediate drug release and enhanced bioavailability.

Water Insoluble

Maintains structural integrity while providing excellent swelling properties for effective disintegration.

Chemical Stability

Excellent chemical stability and compatibility with various active pharmaceutical ingredients.

Low Concentration

Effective at low concentrations (1-5%), allowing for more active ingredient in formulations.

Quick Info

Chemical Name: Cross-linked Polyvinylpyrrolidone
Grade: XL-10
Appearance: White to off-white powder
Particle Size: Fine powder
Solubility: Insoluble in water
pH: 5.0 - 8.0 (1% aqueous dispersion)

Compliance

USP EP JP IP

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Technical Specifications

Parameter	Specification	Test Method
Appearance	White to off-white, free-flowing powder	Visual
Identification	Complies with USP/EP standards	IR Spectroscopy
pH (1% aqueous dispersion)	5.0 - 8.0	USP <711>
Loss on Drying	≤ 5.0%	USP <731>
Residue on Ignition	≤ 0.1%	USP <281>
Heavy Metals	≤ 10 ppm	USP <231>
Nitrogen Content	11.5 - 12.8%	USP <461>
Particle Size Distribution	≥ 95% through 100 mesh	USP <786>
Bulk Density	0.3 - 0.6 g/mL	USP <616>
Tapped Density	0.4 - 0.8 g/mL	USP <616>
Microbial Limits	Total Aerobic Count: ≤ 1000 CFU/g Yeast & Mold: ≤ 100 CFU/g	USP <61>

Applications

Immediate Release Tablets

Primary application as super disintegrant for rapid drug release and enhanced bioavailability.

Hard Gelatin Capsules

Used in capsule formulations to improve drug dissolution and release characteristics.

Chewable Tablets

Enhances disintegration in chewable formulations for improved palatability and drug release.

Orally Disintegrating Tablets

Ideal for ODT formulations requiring rapid disintegration in the oral cavity.

Direct Compression

Suitable for direct compression processes with excellent flow and compaction properties.

Wet Granulation

Compatible with wet granulation processes for improved tablet properties.

Regulatory Compliance

Our Crospovidone (XL-10) meets the highest international pharmaceutical standards and regulatory requirements.

USP

United States Pharmacopeia

EP

European Pharmacopoeia

JP

Japanese Pharmacopoeia

IP

Indian Pharmacopoeia

BP

British Pharmacopoeia

Certifications

ISO 9001:2015

Quality Management

ISO 14001:2015

Environmental Management

ISO 45001:2018

Occupational Health & Safety

ISO 22000:2018

Food Safety Management

FSSAI

Food Safety Standards

WHO-GMP

Good Manufacturing Practice

HALAL

Halal Certified

KOSHER

Kosher Certified