JayCel™ Sphere-200

JayCel™ Sphere-200 is a premium pharmaceutical-grade spherical Microcrystalline Cellulose engineered for superior sphericity, controlled particle distribution, and exceptional mechanical stability. Designed for advanced pelletization, coating, capsule filling, and controlled-release applications, it delivers excellent flow behavior, low friability, and consistent performance across pharmaceutical and specialty drug delivery formulations.

Technical Details

JayCel™ Sphere-200 Microcrystalline Cellulose Spheres

Appearance Round Spheres

Particle Size 200–300 µm

Bulk Density 0.8 g/ml

Sphericity NLT 85

Physical Characteristics

Description White or off white, round shaped sphere. Reference: USP / BP / EP / JP

Solubility Insoluble in water, dilute acids, and most organic solvents including anhydrous ethanol, acetone, and toluene; practically insoluble in sodium hydroxide solution. Reference: USP

pH pH of the supernatant solution should be between 5.0 to 7.5. Reference: USP / BP / EP / JP

Conductivity Conductivity of the supernatant solution should not exceed 75 µS per cm. Reference: USP / BP / EP / JP

Loss on Drying Not more than 7.0% w/w. Reference: USP / BP / EP / JP

Bulk Density 0.8 g/ml. Reference: In house

Identification & Compliance

Infrared Absorption Record the infrared absorption spectrum and compare with the reference spectrum. Reference: USP / BP / EP / JP

Color Reaction The substance takes on a violet-blue color. Reference: USP / BP / EP / JP

Degree of Polymerization NMT-350. Reference: USP / BP / EP / JP

Chemical Purity Profile

Residue on Ignition / Sulphated Ash Not more than 0.1%. Reference: USP / BP / EP / JP

Water Soluble Substances Not more than 0.25% w/w. Reference: USP / BP / EP / JP

Ether Soluble Substances Not more than 0.05% w/w. Reference: USP / BP / EP / JP

Friability < 0.1%. Reference: In house

Swelling Index < 2%. Reference: In house

Sphericity NLT 85. Reference: In house

Particle Size Distribution

Particle Size 45–60 Mesh. Reference: In house

Size Range 200 µm to 300 µm. Reference: In house

Grade Type Spherical Microcrystalline Cellulose. Reference: Product Specification

Microbial Safety Standards

Total Aerobic Microbial Count
NMT 1000 cfu/g. Reference: USP / BP / EP / JP

Total Combined Molds & Yeasts
NMT 100 cfu/g. Reference: USP / BP / EP / JP

Staphylococcus aureus
Absent. Reference: USP

Pseudomonas aeruginosa
Absent. Reference: USP

Escherichia coli
Absent. Reference: USP

Salmonella species
Absent. Reference: USP

Storage & Solvent Compliance

Organic Volatile Impurities Raw materials, manufacturing process, and product do not contain any solvents listed in Organic Volatile Impurities. Reference: USP <467>

Residual Solvents Raw materials, manufacturing process, and product do not contain listed residual solvents. Reference: Ph.Eur <5.4>

Storage Recommendation Preserve in tight containers. Reference: Specification Requirement

Technical Note: JayCel™ Sphere-200 specifications are designed to support spherical particle uniformity, low friability, controlled particle size, excellent flow behavior, and reliable performance in pelletization, coating, capsule filling, and controlled-release pharmaceutical applications.