KSM-66 Ashwagandha    

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ANALYTICAL SPECIFICATIONS
Product Name : KSM-66 ashwagandha ( Withania somnifera )
Plant Part : Roots
No. Tests Limits Protocol
1 Description Light yellow brown hygroscopic powder
2 Identification To pass the test TLC (Thin Layer Chromatography)
3 Physicochemical analysis
Mositure Content (% w/w) < 5.0 As per USP 24<561> Vegetable Drugs pg. 1885. Pg.2005
Ash content (%W/W) < 15.0
Acid insoluble ash (%w/w) < 5.0
pH of 5%w/v solution 4.0 – 6.5 As per USP<791> pg.1977
4 Partical Size
Passing through 40 mesh sieve >95%(w/w)  
Passing through 80 mesh sieve >85%(w/w)
5 Density
Bulk density (g/cc) 0.2 – 0.6 As per USP 24<616>19131914 MethodI
Tapped bulk density (g/cc) 0.2 – 0.8
6 Heavy metals
Lead <1ppm AOAC/AAS
Cadmium <1ppm AOAC/AAS
Arsenic <2ppm AOAC/AAS
Mercury <0.1ppm AOAC/AAS
7 Microbiological analysis as per FIP guidelines
Total viable aerobic count <104 cfu g-1 As per WHO/PHARMA/92.559/Rev.1/pg.4952
Total enterobacteriaceae <102 cfu g-1
Total fungal count <102 cfu g-1
8 Test for specific pathogens as per FIP guidelines
E.Coli Absent IS:5887 (Part I): 1976
Salmonella sp. Absent IS: 15187:2002
S.aureus Absent IS: 5887(Part II): 1976
9 Aflatoxins (B1, B2, G1, G2) < 5 ppb AOAC Chap 49/HPLC
10 Pesticides residue analysis as per USP and BP limits
Organochlorine pesticides To comply with USP AOAC Chap.10/GC/ECD/USP 24
Organophosphorous pesticides
Organosulpher IS: 138321993
11 Phytochemical analysis
Total Withanolides (%w/w) > 5 % By HPLC
( Withaferin A ) < 0.1 %