S. No.

PARAMETERS

SPECIFICATION

01.

Colour

White

02.

Description

Have to corresponds as USP26/NF21

03.

Identification A,B,C

Have to corresponds as USP26/NF21.

04.

Degree of Polymerization

NMT 350 as USP 26/NF21

05.

Assay (Dried)

97% to 102%.

06.

PH

5.0-7.5 as USP 26/NF21

07.

Bulk Density

0.26 to 0.32 g/ml.

08.

Water-Soluble substance

NMT 0.24% as USP 26/NF21

09.

Ether-soluble substance

NMT 0.05% as USP 26/NF21

10.

Loss on Drying

NMT 6.0% as USP 26/NF21

11.

Conductivity

NMT 75 uS as USP 26/NF21

12.

Heavy Metals

NMT 10 ppm as USP 26/NF21

13.

Residue on Ignition

NMT 0.05%  as USP 26/NF21

14.

Organic Volatile Impurities

Have to correspond as USP 26/NF 21

15.

Sieve Analysis (%Retention)
                    400 Mesh           
                                

NMT 10.0%

MICROBIAL LIMITS

01.

Total  Aerobic microbial Count

NMT1000/g as USP26/NF21

02.

Total Yeast & Mould Count

NMT100/g as  USP26/NF21

03.

Staphylococcus Aureus

Absent as USP26/NF21

04.

Escherichia Coli

Absent as USP26/NF21

05.

Pseudomonas  Aeruginosa

Absent as USP26/NF21

06.

Salmonella Species

Absent as USP26/NF21