Sl. No.

Tests

Limits

Protocol

1.          

Description

Light brown to Dark brown powder

2.          

Identification

To pass the test

By TLC

3.          

Physico-chemical analysis

< 7.0

As per USP <921> Method III

Loss on drying  (%w/w)

Ash content (%w/w)

< 25.0

As per USP<561>

Acid insoluble Ash (%w/w)

< 3.0

Total soluble solids (%w/w)

> 85.0

4.          

Particle Size

0.20 - 0.60

As per USP <616> Method - I

Bulk Density (g/cc)

Tapped bulk density (g/cc)

0.20 - 0.80

Material passing through 30# BS/35 ASTM (%w/w)

> 99.0

As per USP <786> Particle Size distribution.

5.          

Heavy metal analysis

< 10 ppm

AAS / ICP -ES

Lead

Arsenic

< 2 ppm

Cadmium

< 1 ppm

Mercury

< 0.1 ppm

6.          

Microbiological analysis

< 10⁴ cfu g^-1

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

As per FIP Guidelines

Total Viable Aerobic Count

Total Enterobacteriaceae

< 10² org g^-1

Total Fungal Count

< 10² fs g^-1

7.          

Test for Specific Pathogen

Absent

As per FIP Guidelines

E.coli (1g)

Salmonella Sp. (10g)

Absent

S.aureus (1g)

Absent

8.          

Mycotoxin analysis

< 5 ppb

As per USP

Aflatoxins (B₁ + B₂ + G₁ + G₂)

9.          

Pesticide residue analysis

To comply with USP

As per AOAC / USP

As per USP & BP Limits

Organochlorine Pesticides

Organophosphorus Pesticides

Synthetic pyrethroids

10.       

Bio-Assay

< 50.0

[NR/BSY/SOP/015/02]

Alpha Glucosidase Inhibition IC₅₀ (mcg/ml)