MICCEL – L

Microcrystalline Cellulose and Lactose Monohydrate

Co – Processed IH

Co-processed microcrystalline cellulose-USP with lactose monohydrate – USP IS Provides capability for direct compression, due to increased in flowability and compactability.

MICCEL – L is the mixture of microcrystalline cellulose 25% and ALPHA Lactose Monohydrate 75%

Specification

Sr. no. Test Specification
1 Description White of almost white, fine of granular powder, odouless
2 Solubility Slightly soluble in water
3 Identification
3.1 Test – A (IR Absorption) Should be comply
3.2 Test – B (Microcrystalline Cellulose) Violet-blue colour should be produced
4.0 ph 4.0 to 7.0
5.0 Loss on Drying ,% NMT 1.5
6.0 Water,% 4.0 to 6.0
7.0 Arsenic, ppm NMT 1 ppm
8.0 Heavy Metals, ppm NMT 5
9.0 Sulphated Ash, % NMT 0.1
10.0 Assay, %(For Microcrystalline Cellulose) 23.0 to 27.0
(Calculated on Anhydrous Basis)
11.0 Microbiological Analysis  
11.1 Total Aerobic Microbial Count, CFU/g NMT 100
11.2 Total Combined Yeasts & Moulds Count, CFU/g NMT 50
11.3 Escherichia Coli/g Should be absent
11.4 Salmonella Species/10g Should be absent
11.5 Shigelia,/10g Should be absent
12.0 Particle Size Distribution, (By Retsch.Model AS200 Digit)  
60#, % NLT 90
100#, % 45-70
400#, % NMT 15
Test MICCEL – L
Loss on drying (%) NMT 1.5
Weight % Passing through 60 mesh NLT 90
Weight % Passing through 100 mesh 45 to 70
Weight % Passing through 400 mesh NMT 15