1.          

Description

Light brown to Brown hygroscopic powder.

2.          

Solubility

Soluble in water

1g in 100 ml

3.          

Identification

To pass the test

 By HPLC

4.          

Physico-chemical analysis

< 10.0

5.          

Particle Size

> 95.0

As per USP <786>
Particle Size distribution.

6.          

Heavy metal analysis

< 10 ppm

AAS / ICP –ES

Arsenic

< 2 ppm

Cadmium

< 1 ppm

7.          

Microbiological analysis

< 10⁴ cfu g^-1

As per WHO/PHARMA/92.559/Rev.1
Pg.49-52 /
As per USP <61> & <62>

Total Enterobacteriaceae

< 10² org g^-1

Total Fungal Count

< 10² fs g^-1

8.          

Test for Specific Pathogen

As per FIP Guidelines

E.coli (1g)

Salmonella Sp. (10g)

S.aureus (1g)

9.       

Mycotoxin analysis

< 5 ppb

 As per USP
Test for Aflatoxins

Aflatoxins (B₁ + B₂ + G₁ + G₂)