WITHANIA SOMNIFERA (ASHWAGANDHA) EXTRACT – MONOGRAPH  
 
The drug consists of roots of Withania somnifera Dunal; Fam. : Asteraceae. It grows as a stout shrub that reaches a height of 170 cm (5 to 6 feet). Like the tomato which belongs to the same family, it bears yellow flowers and red fruit, though its fruit is berry-like in size and shape. Ashwagandha grows prolifically in India, Nepal, Pakistan, Sri Lanka and Bangladesh.
 
  English: Winter cherry  
  Vernacular: Ashwagandha  
  Part Used:Roots  
  Family:Asteraceae  
  Indication:Mental Health  
  Pharmacology :  
 
Withania somnifera (Ashwagandha): Ashwagandha is one of the most valuable herbs in the Ayurvedic medical system. As reported, the unique property of Ashwagandha is its mind calming effect. The major biochemical constituents of Withania from which its primary medicinal properties emanate, are certain alkaloids and lactones called withanolides.
 
 
Traditional Use:Decoction of Ashwagandha is given to old people and pregnant women as a nutrient & health restorative. It is also taken in the form of crude drug powder along with milk. Withania somnifera is also recommended for spermatorrhoea, infertility in women, leucorrhoea etc.
 
  Marker constituents:Withanolides  
 
Mode of Action: It reduces stress. As per ayurvedic concept is concerned stress is a condition that occurs in our body due to vata dosha vitiation. It helps are body to attain such stability especially where vata imbalance is concerned. It is blessed with is the power to strengthen our nervous system. The protective action of phyto-constituents helps in inhibiting the convulsions and wobbly movements of the body caused due to disturbances in the central nervous system (CNS). It is used to reduce tension and anxiety, over-excitability and hysterical states. It is calming without exerting too sedative an effect and is practically non-addictive. The drug have a regulatory effect on the autonomic nervous system - one fraction has a suppressant effect, another stimulant one, so that in combination they have an amphoteric effect. It may also be applied locally as a treatment for cramps and other muscle tensions.
 
  Presentation: Pack of 1kg, 5kg & Bulk pack, Light yellowish brown colour dry powder extract with > 2.5% Total withanolides  
  Storage: Store in cool dry place  
  Shelf Life: Best before 3 years from manufacturing date.  
     
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Issue No. :   QAS/12/A – 37
 Page No :  01 OF 01
 Revision  No. :    00 
 
 Analytical Specification
 
 Issue Date :  January 2009
 Review Date :  January 2011
 Title :  WITHANIA SOMNIFERA (ASHWAGANDHA) DRY EXTRACT (> 2.5% TOTAL WITHANOLIDES)
 
 Part Used :  Roots
 Ratio :  5:1
 Fresh / Dry :  Dry
 
 Sr.No.  Test  Limits  Protocol
01.  Description  Light yellowish brown coloured powder with  characteristic odour & bitter taste
02.  Identification
 Identification  Compared with standard  By TLC
03.  Physical Chemical Test (As per API)
 3.1 Water Soluble  extractive  Not Less Than  80.0%  As per API method
 3.2 Alcohol Soluble  Extractive (50%)  Not Less Than  70.0%
 3.3 pH of 1% w/v  solution  4.50-7.50
 3.4 Loss On Drying  Not More Than  8.0%
 3.5 Total Ash  Not More Than  10.0%
 04.  Heavy metal Analysis  (As Per WHO & FDA Guideline)
 4.1 Lead  < 10 ppm  AAS/ICP – ES
 4.2 Cadmium  < 0.03 ppm
 4.3 Arsenic  < 10.0 ppm
 4.4 Mercury  < 1.0 ppm
 05.  Microbiological Analysis  (As Per WHO & IP 2007 Guideline)
 5.1 Total Microbial  Count  < 107 cfu gm-1  As per INH  method
 5.2 E.Coli (1 gm)  Absent
 5.3 Salmonella (1  gm)  Absent
 5.4 Pseudomonas  aeruginosa (1 g)  Absent
 5.5 Yeast & Molds  < 105 cfu gm-1>
 06.  Phytochemical Analysis
 6.1 Assay Of Total  Withanolides  Not less Than  2.5%  By Gravimetric
 6.2 Assay Of  Alkaloids  Not Less Than 0.5%