Silicified microcrystalline cellulose | Silicified microcrystalline cellulose USP

USFDA TYPE IV DMF NO. 031300

Description

Silicified Microcrystalline Cellulose – USP

Solution for Optimum Compatibility

Silicification of MCC increased physical properties such as true density, Hausner ratio, porosity, ejection force and specific surface area. Other properties such as bulk and tap densities were reduced due to the amorphous and light character of fumed silica.

MICCEL S is the mixture of microcrystalline cellulose and colloidal silicon dioxide (MCC/CSD at 98:2 ratio) and most compactible grade of SMC with flow characteristics similar to doubling the parties size of MCC.

Specification

Sr.no.	Test	Specification
1.	Description	White or almost white, very fine to moderately fine powder. It is a free-flowing material.
	Solubility	Slightly soluble in sodium hydroxide solution (1 in 20); practically insoluble in water, in acetone, in ethanol, in toluene, and in diluted acid.
2.	Identification
	Test-A (IR Absorption)	Should be comply
	Test-B	The substance takes on a violet-blue color should be produced.
	Test-C	A deep yellow color is produced
	Test-D(silica dispersion uniformity test)	NMT 0.02
3.	Impurities
	Heavy Metals, µg/g	NMT 10
4.	Specific Tests
	Residue on Ignition, %	1.8 – 2.2
5.	Microbiological Analysis
	Total Aerobic Microbial Count, CFU/g	NMT 1000
	Total Combined Molds and Yeasts Count, CFU/g	NMT100
	Escherichia Coli/g	Should be absent
	Pseudomonas Aeruginosa/g	Should be absent
	Staphylococcus Aureus/ g	Should be absent
	Salmonella Species/ 10g	Should be absent
6.	Conductivity, µS/cm	NMT 75
	pH	5.0 – 7.5
	Loss on Drying, %	NMT 7.0
	Degree of Polymerization	NMT 350
	Bulk Density	Refer chart
	Particle Size Distribution	Refer chart
	Water Soluble Substances, %	NMT 0.25
	Ether Soluble Substances, %	NMT 0.25

Grade wise in house specification

Grade Wise In House Specification

Test	MICCEL S-101	MICCEL S-102	MICCEL S-102 HD	MICCEL S-112
Loss on drying (%)	NMT 7.0	NMT 7.0	NMT 7.0	NMT 1.5
Bulk Density, g/ml	0.28 to 0.33	0.25 to 0.37	0.38 to 0.50	0.25 to 0.37
% Retention on 60 #	NMT 1	NMT 8	NMT 8	NMT 8
% Retention on 200#	NMT 30	NLT 45	NLT 45	NLT 45