JayCel™-113

JayCel™-113 is a low-moisture pharmaceutical-grade Microcrystalline Cellulose designed for stable processing, reliable compressibility, and consistent formulation performance. With controlled particle distribution, reduced loss on drying, and balanced bulk density, it supports dependable tablet manufacturing across pharmaceutical, nutraceutical, and advanced solid dosage applications.

Technical Details

JayCel™-113 Microcrystalline Cellulose

Appearance White Powder

pH Range 5.0 – 7.5

Assay Dried 97.0 – 102.0%

Bulk Density 0.27 – 0.34 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 1.5% w/w. Reference: USP/NF, JP, Ph.Eur.,BP

Bulk Density 0.27 to 0.34 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

≤ 30µ

Reference: In house

D50

40 – 60µ

Reference: In house

D90

≥ 80µ

Reference: In house

Sieve Analysis

60 Mesh Retention ≤ 1.0% Reference: In house

200 Mesh Retention ≤ 30.0% 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™-113 specifications are designed to support low-moisture stability, controlled formulation performance, and reliable compliance across pharmaceutical and nutraceutical applications.