JayCel™-200

JayCel™-200 is a coarse-particle pharmaceutical-grade Microcrystalline Cellulose engineered for superior flow performance, enhanced die filling, and efficient high-speed compression applications. With optimized particle distribution and elevated bulk density, it delivers excellent process stability, improved granule movement, and reliable formulation consistency across pharmaceutical, nutraceutical, and industrial solid dosage manufacturing environments.

Technical Details

JayCel™-200 Microcrystalline Cellulose

JayCel™-200 is a coarse-particle pharmaceutical-grade Microcrystalline Cellulose developed for enhanced flowability, superior granule consistency, and efficient high-speed tableting applications. With optimized bulk density and larger particle distribution, it supports excellent processing performance, reliable compressibility, and stable formulation behavior across pharmaceutical, nutraceutical, and industrial solid dosage manufacturing applications.

Appearance White Powder

pH Range 5.0 – 7.5

Assay Dried 97.0 – 102.0%

Bulk Density 0.30 – 0.40 g/ml

Physical Characteristics

Description White or almost white, fine or granular crystalline powder. Reference: USP

Solubility Insoluble in water, dilute acids, and most organic solvents including anhydrous ethanol, acetone, and toluene. Reference: Ph. Eur / BP

Sodium Hydroxide Solubility Practically insoluble in sodium hydroxide solution. Reference: Ph. Eur / BP

Special Solubility Test Dissolve 50 mg in 10 ml ammonical solution of copper tetramine R. It dissolves completely, leaving no residue. Reference: Ph. Eur / BP

pH pH of the supernatant solution should between 5.0 to 7.5. Reference: USP/NF, JP,Ph.Eur.,BP

Conductivity Conductivity of the supernatant solution should not exceed 75 µS per cm. Reference: USP/NF, JP,Ph.Eur.,BP

Loss on Drying Not More than 7.0% w/w. Reference: USP/NF, JP,Ph.Eur.,BP

Bulk Density 0.30 to 0.40 g/ml. Reference: In house

Degree of Brightness 85% Reference: In house

Angle of Repose Max 42° Reference: In house

Identification & Compliance

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

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

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

Chemical Purity Profile

Residue on Ignition / Sulphated Ash Not More than 0.1% Reference: USP/NF, JP,Ph.Eur.,BP

Starch & Dextrins Complies with IP limit test Reference: IP

Organic Impurities Have to correspond as per IP Reference: IP

Water Soluble Substances Not More than 0.25% w/w. Reference: USP/NF, JP,Ph.Eur.,BP

Ether Soluble Substances Not More than 0.05% w/w. Reference: USP/NF, JP,Ph.Eur.,BP

Heavy Metals Not More than 10 ppm. Reference: USP/NF, JP,Ph.Eur.,BP

Arsenic Not More than 2 PPM Reference: IP

Assay (Dried) 97.0 – 102.0 Reference: In house

Particle Size Distribution

D10

< 70 µ

Reference: In house

D50

150 – 200 µ

Reference: In house

D90

> 260 µ

Reference: In house

Sieve Analysis

60 Mesh Retention > 10.0% Reference: In house

100 Mesh Retention > 50.0 % Reference: In house

Microbial Safety Standards

Total aerobic microbial count
Max.:1000 cfu/ g Reference: USP/NF, JP,Ph.Eur.,BP

Total combined molds & yeasts
Max.: 100 cfu/g Reference: USP/NF, JP,Ph.Eur.,BP

Staphylococcus aureus
Absent Reference: USP/NF, JP,Ph.Eur.,BP

Pseudomonas aeruginosa
Absent Reference: USP/NF, JP,Ph.Eur.,BP

Escherichia coli
Absent Reference: USP/NF, JP,Ph.Eur.,BP

Salmonella species
Absent Reference: USP/NF, JP,Ph.Eur.,BP

Storage & Solvent Compliance

Organic Volatile Impurities Product does not contain solvents listed in USP <467> Reference: USP <467>

Residual Solvents Product does not contain residual solvents listed in Ph.Eur <5.4> Reference: Ph.Eur <5.4>

Storage Recommendation Preserve in tight containers. Reference: Specification Requirement

Technical Note: JayCel™-200 specifications are designed to support coarse-particle flowability, enhanced processing efficiency, and reliable compliance across pharmaceutical and nutraceutical applications.