JayCel™-105

Engineered for advanced pharmaceutical processing, JayCel™-105 delivers exceptional particle fineness, enhanced surface area distribution, and superior formulation consistency. Its optimized ultra-fine structure supports efficient blending, uniform drug dispersion, and reliable tablet performance, making it an ideal choice for high-precision pharmaceutical and nutraceutical manufacturing environments.

Technical Details

JayCel™-105 Microcrystalline Cellulose

JayCel™-105 is an ultra-fine pharmaceutical-grade Microcrystalline Cellulose specially engineered for precision formulations requiring exceptional smoothness, superior blending uniformity, and enhanced surface distribution. With its fine particle size profile and controlled bulk density, it delivers outstanding compressibility, improved content uniformity, and reliable performance across pharmaceutical, nutraceutical, and advanced solid dosage manufacturing applications.

AppearanceWhite Powder

pH Range5.0 – 7.5

Assay Dried97.0 – 102.0%

Bulk Density0.20 – 0.30 g/ml

Physical Characteristics

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

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

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

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

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

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

Loss on DryingNot more than 5.0% w/w.Reference: USP/NF, JP, Ph.Eur, BP

Bulk Density0.20 to 0.30 g/ml.Reference: In-house

Degree of Brightness85%.Reference: In-house

Angle of ReposeMaximum 42°.Reference: In-house

Identification & Compliance

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

Color ReactionThe substance takes on a violet-blue color.Reference: USP, Ph.Eur, BP, JP

Degree of PolymerizationNot more than 350.Reference: USP, Ph.Eur, BP, JP

Chemical Purity Profile

Residue on Ignition / Sulphated AshNot more than 0.1%.Reference: USP/NF, JP, Ph.Eur, BP

Starch & DextrinsComplies with IP limit test.Reference: IP

Organic ImpuritiesHave to correspond as per IP.Reference: IP

Water Soluble SubstancesNot more than 0.25% w/w.Reference: USP/NF, JP, Ph.Eur, BP

Ether Soluble SubstancesNot more than 0.05% w/w.Reference: USP/NF, JP, Ph.Eur, BP

Heavy MetalsNot more than 10 ppm.Reference: USP/NF, JP, Ph.Eur, BP

ArsenicNot more than 2 ppm.Reference: IP

Assay Dried97.0 – 102.0%.Reference: In-house

Particle Size Distribution

D10

02 – 10 µ

Reference: In-house

D50

15 – 25 µ

Reference: In-house

D90

20 – 60 µ

Reference: In-house

Sieve Analysis

400 Mesh Passes Through< 10.0%.Reference: In-house

Microbial Safety Standards

Total Aerobic Microbial Count
Maximum 1000 cfu/g.Reference: USP/NF, JP, Ph.Eur, BP

Total Combined Molds & Yeasts
Maximum 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

Storage RecommendationPreserve in tight containers.Reference: Specification Requirement

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

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

Technical Note: JayCel™-105 specifications are designed to support ultra-fine particle performance, controlled quality, and reliable compliance across pharmaceutical and industrial formulation requirements.