JayCel™-SMCC 50

JayCel™-SMCC 50 is a premium Silicified Microcrystalline Cellulose engineered for enhanced flow properties, improved compactibility, and superior tablet strength in direct compression formulations. Combining the functional benefits of Microcrystalline Cellulose with colloidal silicon dioxide, it delivers excellent process efficiency, reduced friability, improved blending uniformity, and reliable manufacturing performance across pharmaceutical and nutraceutical applications.

Technical Details

JayCel™-SMCC 50 Silicified Microcrystalline Cellulose

JayCel™-SMCC 50 is an advanced Silicified Microcrystalline Cellulose designed for superior flowability, improved compactibility, and enhanced direct-compression performance. Engineered as a free-flowing excipient, it supports better blending, improved tablet hardness, reduced friability, and consistent processing performance across pharmaceutical, nutraceutical, and high-performance solid dosage applications.

Appearance Free-Flowing Powder
pH Range 5.0 – 7.5
Assay Dried 97.0 – 102.0%
Bulk Density 0.26 – 0.34 g/ml

Physical Characteristics

Description White or almost white, very fine to moderately fine powder. It is a free-flowing material. Reference: USP
Solubility in Sodium Hydroxide Slightly soluble in sodium hydroxide solution. Reference: Ph. Eur / BP
General Solubility Practically insoluble in water, acetone, ethanol, toluene, and dilute acid. Reference: Ph. Eur / BP
Solubility in Ammonical Copper Tetramine It dissolves completely, leaving no residue. Reference: IP / BP / Ph. Eur. / USP-NF
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 5.0% w/w. Reference: USP/NF, JP, Ph.Eur., BP
Bulk Density 0.26 to 0.34 g/ml. Reference: In house
Degree of Brightness ≥ 85 % Reference: In house
Angle of Repose 35 - 45° Reference: In house

Identification & Compliance

Infrared Absorption Violet-blue colour should be produced. Reference: JP / USP
Color Reaction Deep yellow color is produced. Reference: USP / Ph.Eur / BP / JP
Variance Variance should not exceed 0.02. Reference: USP / Ph.Eur / BP / JP

Chemical Purity Profile

Residue on Ignition / Sulphated Ash 1.8 - 2.2 % W / W 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: 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
1000 cfu/g Reference: USP/NF, JP, Ph.Eur., BP
Total combined molds & yeasts
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 Organic Volatile Impurities. Reference: USP <467>
Residual Solvents Product does not contain residual solvents. Reference: Ph.Eur <5.4>
Storage Recommendation Preserve in tight containers. Reference: Specification Requirement
Technical Note: JayCel™-SMCC 50 specifications are designed to support enhanced flowability, improved compactibility, and reliable compliance across pharmaceutical and nutraceutical direct-compression applications.
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