fRchem

Specifications

PHYSICOCHEMICAL TESTS

Appearance

White or almost white, fine or granular powder

Physical Solubility

Practically insoluble in water, in acetone, in anhydrous ethanol, in toluene and in dilute acids.

Identification (Chemical Test)

Corresponds as per USP, BP, Ph.Eur., JP, IP

Identification (Degree of Polymerization)

NMT 350 as per USP, BP, Ph.Eur., JP

Solubility (Coppertetramine Solution)

Corresponds as per BP, Ph.Eur., JP

pH

5.0 - 7.5 as per USP, BP, Ph.Eur., JP, IP

Conductivity

NMT 75 µS.cm-1 as per USP, BP, Ph.Eur., JP

Ether Soluble Substance

Max. 0.05% as per USP, BP, Ph.Eur., JP

Water Soluble Substance

Max. 0.25% as per USP, BP, Ph.Eur., JP, IP

Loss on Drying

NMT 7.0% as per USP, BP, Ph.Eur., JP, IP

Heavy Metals

NMT 10 ppm as per IP

Residue on Ignition/Sulphated Ash

NMT 0.1% - 0.2% as per USP, BP, Ph.Eur., JP, IP

Starch and Dextrin

Complies the test as per IP

Organic Impurities

Complies the test as per IP

Arsenic

NMT 2 ppm as per IP

Assay

97.0% - 102.0% as per IP

* NMT - Not more than
* NLT - Not less than
* ppm - Parts per million

MICROBIAL TESTS

Total Aerobic Microbial Counts

NMT 1000 CFU/g as per USP, BP, Ph.Eur., JP, IP

Total Yeast and Mould Counts

NMT 100 CFU/g as per USP, BP, Ph.Eur., JP

Escherichia Coli

Absent as per USP, BP, Ph.Eur., JP

Pseudomonas Aeruginosa

Absent as per USP, BP, Ph.Eur., JP

Staphylococcus Aureus

Absent as per USP, BP, Ph.Eur., JP

Salmonella Species

Absent as per USP, BP, Ph.Eur., JP

* CFU - Colony forming unit

Grades

Grade	Average Particle Size (µm)	Bulk Density (g/ml)	Moisture (%)
FR-Cell 101	50	0.25 - 0.34	NMT 6
FR-Cell 102	90	0.26 - 0.34	NMT 6
FR-Cell 103	50	0.25 - 0.34	NMT 3
FR-Cell 105	20	0.20 - 0.30	NMT 6
FR-Cell 112	90	0.26 - 0.35	NMT 2
FR-Cell 113	50	0.26 - 0.34	NMT 2
FR-Cell 12	110	0.29 - 0.36	NMT 6
FR-Cell 14	110	0.34 - 0.45	NMT 2
FR-Cell 200	180	0.26 - 0.37	NMT 6
FR-Cell 301	50	0.34 - 0.43	NMT 6
FR-Cell 302	90	0.35 - 0.43	NMT 6

* NOTE - Brightness for above grades >88%
* NMT - Not more than

Grade	Average Particle Size (µm)	Bulk Density (g/ml)	Moisture (%)
FR-Cell Prime 101	50	0.27 - 0.33	3.0 - 5.0
FR-Cell Prime 102	90	0.28 - 0.33	3.0 - 5.0
FR-Cell Prime 112	90	0.28 - 0.34	NMT 1.5
FR-Cell Prime 200	180	0.31 - 0.38	3.0 - 5.0
FR-Cell Prime 802	50	0.13 - 0.23	2.0 - 5.0