Microcrystalline Cellulose
Specification Comparision Grade Use Application Recommended Use Level COA Storage & Packing
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COA
Product MICROCRYSTALLINE CELLULOSE
Grade ACCEL PH 102
Batch No. 6 Dight (Alpha Numeric)
Mfg. Date dd/mm/yyyy
Expirty Date 5 Years from the date of mfg.
Batch Quantity Upto 10 Tonnes
Mfg. Drug License No. G/1615 Dt: 16/08/02
Method of Analysis USP 28 / NF 23
 
Sr. No. Parameters Results Specifications
01 Colour White White
02 Description Passes Have to correspond as USP 26/NF21
03 Identification A, B, C Passes Have to correspond as USP 26/NF21
04 Degree of Polymerization Avg. Value NMT 350 as USP 26/NF21
05 Assay (Dried) Avg. Value 97.0% 102%
06 pH Avg. Value <5.0-7.5 as USP 26/NF21
07 Bulk Density Avg. Value 0.26 to 0.32 g/ml
08 Water soluble substance Avg. Value NMT 0.24% as USP 26/NF21
09 Ether solutble substance Avg. Value NMT 0.05% as USP 26/NF21
10 Loss on Drying Avg. Value NMT 6.0% as USP 26/NF21
11 Conductivity Avg. Value NMT 75µS as USP 26/NF21
12 Heavy Metals Complies NMT 10 ppm as USP 26/NF21
13 Residue on Ignition Avg. Value NMT 0.05% as USP 26/NF21
14 Organic Value Impurities Complies Have to correspond as USP 26/NF21
15 Sieve Analysis (%Retention)
60 Mesh
200 Mesh		 Avg. Value
Avg. Value		 < 8.0%
> 45.0%
16 Particle Size Distribution
D10
D50
D90 		Avg. Value
Avg. Value
Avg. Value		 < 45 µ
80-100 µ
>140 µ
MICROBIAL LIMITS
01 Total Aerobic Microbial Count <100 c.f.u./g NMT 100 c.f.u./g as USP 26/NF21
02 Total Yeast & Mould Count <10 c.f.u./g NMT 10 c.f.u./g as USP 26/NF21
03 Staphylococcus Aureus Absent Absent as USP 26/NF21
04 Escherichia Coli Absent Absent as USP 26/NF21
05 Pseudomonas Aeruginosa Absent Absent as USP 26/NF21
06 Salmonella Species Absent Absent as USP 26/NF21
The Batch described on this certificate is released on the basis of the results ascertained.
 
 
Design by : ACCURATE INFOCOM