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   LYCOPENE
   

 DOC NO. :  NR/QCD/SPC/121
 ISSUE DATE :  02.07.2007
 REVISION NO. :  00
   ANALYTICAL SPECIFICATION  NUMBER OF PAGES :  01
   TITLE : LYCOPENE

No.

Tests

Limits

Protocol

1.       

Description

Reddish brown thin liquid

2.       

Identification by TLC

To pass the test

3.       

Physico-chemical analysis

Soluble in Dichloromethane (DCM), partly soluble in alcohol 

 

1g in 100ml

Solubility

Moisture (%w/w)

< 10.0

As per USP <921> Method II

4.       

Heavy metal analysis

< 10 ppm

AAS / ICP -ES

Lead

Arsenic

< 2 ppm

Cadmium

< 1 ppm

Mercury

< 0.1 ppm

5.       

Microbiological analysis

< 104 cfu g-1

As per WHO/PHARMA/92.559/Rev.1 Pg.49-52

As per FIP Guidelines

Total Viable Aerobic Count

Total Enterobacteriaceae

< 102 org g-1

Total Fungal Count

< 102 fs g-1

6.       

Test for Specific Pathogen

Absent

As per FIP Guidelines

E.coli (1g)

Salmonella Sp. (10g)

Absent

S.aureus (1g)

Absent

7.       

Mycotoxin analysis

< 5 ppb

As per USP

Aflatoxins (B1 + B2 + G1 + G2)

8.       

Phytochemical analysis

 

 

Lycopene content (%w/w)

³ 5.0

By Spectrophotometry

 

 DOC NO. :  NR/QCD/SPC/122
 ISSUE DATE :  02.07.2007
 REVISION NO. :  00
   ANALYTICAL SPECIFICATION  NUMBER OF PAGES :  01
   TITLE : LYCOPENE

No.

Tests

Limits

Protocol

1.       

Description

Reddish brown thick liquid

2.       

Identification by TLC

To pass the test

3.       

Physico-chemical analysis

 Soluble in Dichloromethane (DCM), partly soluble in alcohol 

1g in 100ml

Solubility

Moisture (%w/w)

< 10.0

As per USP <921> Method II

4.       

Heavy metal analysis

< 10 ppm

AAS / ICP -ES

Lead

Arsenic

< 2 ppm

Cadmium

< 1 ppm

Mercury

< 0.1 ppm

5.       

Microbiological analysis

< 104 cfu g-1

As per WHO/PHARMA/92.559/Rev.1 Pg.49-52

As per FIP Guidelines

Total Viable Aerobic Count

Total Enterobacteriaceae

< 102 org g-1

Total Fungal Count

< 102 fs g-1

6.       

Test for Specific Pathogen

Absent

As per FIP Guidelines

E.coli (1g)

Salmonella Sp. (10g)

Absent

S.aureus (1g)

Absent

7.       

Mycotoxin analysis

< 5 ppb

As per USP

Aflatoxins (B1 + B2 + G1 + G2)

8.       

Phytochemical analysis

 

 

Lycopene content (%w/w)

³ 10.0

By Spectrophotometry

 

 
             
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