Senna Leaf Dry extract 10 % BP

SENNA DRY EXTRACT  10 % BP

S.NO

TEST PARAMETER

SPECIFICATION /LIMIT

REFERENCE

01

Botanical Source

Cassia angustifolia

BP-2016

02

Parts Used

Leaves / Pods

03

Method of Extraction 

Solvent extraction & Isolation semisynthesis  

In-house Method

04

Description /Appearance

Brownish or brown powder

BP-2016

 

05

Taste & Odour

Characteristic

Organoleptic

06

Identification

Positive for sennoside content

BP-2016

 

07

Loss on drying  ( at 105°C )

NMT 5 % w/w

08

pH (10 % w/v)

6-8

In-house specification

09

Residue of Ignition

(Ignited at 800 ±25 °C )

use of sulphuric acid being omitted

 

NMT 20 % w/w

In-house specification

10

Bulk  density

Tap density

0.3-0.4 gm/ml

0.4-0.8 gm/ml

BP-2016 Monograph

(Ph Eur. Method 2.9.34)

 

11

Solubility in warm water

( 37°C , 1 %w/v)

NLT 80 %

In-house specification

12

Particle size

100 % passing through 40 mesh

In-house specification

13

Heavy Metals

NMT 10 PPM

USP-2018

14

Assay:

Total sennosides expressed in

Percent , on dry basis using

     UV-VIS Spectrophotometer

 

NLT 10 % w/w

BP-2016 Vol IV

Page No. 379

 

15

Microbial Analysis                        

    Total Aerobic microbial count

    Yeast & Mould

    Escherichia coli

    Salmonella typhi

 

NMT 103 cfu/gm

NMT 102 cfu/gm

Should be absent

Should be absent

 

USP-2018

16

Pesticide Residue

To comply with the prescribed limits

WHO

17

Aflotoxins (B1,B2,G1,G2)

To comply with the prescribed limits

WHO

18

Residual solvent (Methanol)

NMT 3000 PPM

USP-2018

19

Shelf Life

60 Months

 

20

Storage

Store protected from light in air tight containers