JayCel™-101

JayCel™-101 is a high-performance pharmaceutical-grade Microcrystalline Cellulose engineered for outstanding compressibility, excellent binding efficiency, and uniform particle distribution. Developed with advanced manufacturing precision and stringent global quality standards, it ensures consistent formulation stability and reliable performance across pharmaceutical, nutraceutical, and tablet manufacturing applications.

Technical Details

JayCel™-101 Microcrystalline Cellulose

JayCel™-101 is a premium Microcrystalline Cellulose grade designed with controlled physical, chemical, identification, particle-size, and microbial specifications for reliable formulation performance across demanding applications.

AppearanceWhite Powder
pH Range5.0 – 7.5
Assay Dried97.0 – 102.0%
Bulk Density0.26 – 0.34 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 TestDissolves completely in ammonical solution of copper tetramine R, 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 7.0% w/w.Reference: USP/NF, JP, Ph.Eur, BP
Bulk Density0.26 to 0.34 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: IP

Particle Size Distribution

D10

14 – 30 µ

Reference: In-house

D50

40 – 75 µ

Reference: In-house

D90

77 – 156 µ

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
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™-101 specifications are designed to support consistent quality, controlled performance, and reliable compliance across pharmaceutical and industrial formulation requirements.
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