Standardization of Ayurvedic

formulations
 Standardization
Standardization of drug means confirmation of
its identity and determination of its quality and
purity.
• Identity : biological source of drug

• Quality : Active constituents

• Purity : extent of foreign materials

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•
Standardization
Organoleptic evaluation
of Churna
• Microscopic evaluation
• Physical analysis
• Phytochemical analysis
• Particle size
• Test for heavy metals & toxins
• Microbial contamination
• Test for specific pathogen
• Test for alfatoxin
• Pesticide residue
• Shelf life
 Standardization of Churna
Organoleptic evaluation:
• Colour
• Odour
• Taste

Microscopic evaluation
 Standardization of Churna
• Physical evaluation:
• Loss on drying at 105°c
• Total ash
• Acid insoluble ash
• Water soluble extractive
• pH
 Standardization of Churna
Phytochemical evaluation
• Qualitative analysis
• TLC
• HPTLC & HPLC
 Standardization of Churna
Particle size :
• Churna : 80-120 mesh.
• Kwatha Churna : 40-60 mesh.
Microbial contamination
• Total aerobic count
• Enterobacteria count
• Total fungal count
Test for specific pathogen
• E.coli
• Salrnonella spp.
• Pseudomonas spp.
 Standardization of Churna
Pesticide residue:
Methods : Extraction & Purification
Pesticides to be detected:
• Organochlorine pesticide
• Organophosphorus pasticides
• Pyrethroids
Taste for aflatoxins by TLC:- B1,B2,G1,G2
Shelf life
 Parameters for Standardization of
Asava And Arishta

Ayurvedic parameters :
• Clear liquid without any forth
• Pleasant aromatic odour of alcohol
• Should not have sour taste
• No effervescence sound
Parameters for Standardization of
Asava And Arishta
• Organoleptic evaluation
• Physical evaluation:- pH, Specific gravity at 25°c and
total solid
• Alcohol content
• Reducing sugar
• Non- reducing Sugar
• Total Acidity
• Shelf life
• Viscosity
 Acid Value
• The acid value is the number of mg of
Potassium hydroxide required to neutralize the
free acid in 1gm of substance.
• Viscosity: Resistance to flow
• Apparatus : viscometer
 Parameters for standardization of
Avaleha
• Organoleptic
• Physical
• Reducing sugar
• Total sugar
• Chromatography
• Test for heavy metals
• Microbial contamination
• Shelf life
 Parameters for standardization of
Avaleha
Physical evaluation:
• Loss on drying at 105°c
• Total ash
• Acid insoluble ash
• pH
• Specific gravity
• Total solid contents
• Fat contents
Parameters for standardization of
Vati & Gutika
• Organoleptic Parameters :
1. colour
2. Odour
• Total sugar
• Reducing sugar
• Phytochemical assessment
Parameters for standardization of Vati &
Gutika

• Particle size
• Identification : Microscopy , HPTLC & TLC
• Test for Heavy metals & toxins
• Microbial contamination
• Pesticide residue
Parameters for standardization of Vati &
Gutika
Physical evaluation:
• Ash value
• Acid insoluble ash
• Water insoluble ash
• Alcohol soluble extractive
• pH
• Volatile oil
• Melting temperature
• Loss on drying
 Parameters for standardization of Vati
& Gutika
• Pharmaceutical parameters
1. Hardness
2. Uniformity in weight
3. Uniformity in diameter
4. Friability test
5. Dissolution time
6. Disintegration time
• Disintegration test : liquid medium
• Apparatus: Disintegration test apparatus
• Friability test : how much mechanical stress
tablets are able to withstand during their
manufacturing , distributing and handling
• Hardness: how much force is needed to break
• Uniformity of weight:
• Apparatus: Analytical balance
• Tablets which contains <10mg or < 10% W/W
of active ingredient.
• Not applicable to tablets which are containing
trace elements
Parameters for standardizationof
Tailas & Ghritas
• Organoleptic : colour, odour
• Weight /ml
• Viscosity
• Iodine value
• Saponification
• Acid value
• Rancidity : fat oxidization
 Iodine Value
• The iodine value of substance is the weight of
iodine absorbed by 100 part by weight of
substance .
• Applicable for liquid substances.
 Saponification value
• Number of mg of KOH required to neutralize
the fatty acids, resulting from the complete
hydrolysis of 1 gm of the oil & fat.
 Parameters for standardization of
Arka
• Organoleptic
• Physical : pH, Volatile matter, SG, Clarity test
Sterility test
• Chromatography
• Self life
 Shelf life assessments
• The time period during which an active
pharmaceutical ingredients or finished
pharmaceutical products are remain within the
approved stability specification , provided that
it is stored under condition defined on the
containers level.
• Factors : Temperature, Humidity ,Light etc
• It can be calculated by mathematic formulation
• AYUSH : Rule 161B (2005)
1. Churna & Kwatha Churna : 2 yrs
2. Gutika ( herbs) : 3 yrs
3. Avaleha : 3 yrs
4. Asava & Arista : no expiry date.
Thankyou