Standardization of Ayurvedic

formulations
Dr. Vipin Chaurasiya
Pg scholar
VPSV Ayurveda College Kottakkal
 Standardization

• Standardization is a Numerical value or

specific property that quantifies the purity and
quality of drugs and formulations.
• Standardization of drug means confirmation of
its identity and determination of its quality and
purity.

2
• Identity : biological source of drug

• Quality : Active constituents

• Purity : extent of foreign materials

3
 LEGAL NOTICE OF AFI
 Cosmetics Act (1940), Chapter IVA

Formulations included in the Ayurvedic

Formulary may also be manufactured as per
formulae given in various Ayurvedic Classics.
 Standards for the several single drugs of plant,
animal and mineral origin included in the
Pharmacopoeial List of Single Drugs included as
an Appendix to the Ayurvedic Formulary have yet
to be worked out. In the manufacture of medicines
included in this Formulary, it should be ensured
that the Vaidya - in - charge of the Pharmacy has
reasonably satisfied himself about the identity and
purity of the drugs.
 Use of Substitute drugs (Pratinidhi dravyas),
wherever the original drugs are not available, is
permissible in the Ayurvedic classics and practice.
It must, however, be ensured that only the
substitutes as are mentioned in the texts or
included in the Formulary are used.
 Standardization of Churna
• Ayurvedic Parameters :
ू ण ः।
शुष्कपिष्टः सुक्ष्मतान्तविटच्युतश्चर्
तस्यसमस्तद्रव्यािरित्यागादाप्लुतोियोगाच्च कल्कादभेदः॥
(A.S.K.)

अत्यन्तशुष्कं यद्द्रव्यं सुपिष्टं वस्त्रगापलतं ।

तत्स्याच्चर्
ू े िजःक्षोदस्तन्मात्रा कर्ण संपमता ॥
(S.S.M)
 Modern Parameters
• Organoleptic evaluation
• Microscopic evaluation
• Physical analysis
• Phytochemical analysis
• Particle size
• Test for heavy metals & toxins
• Microbial contamination
• Test for specific pathogen
• Test for alfa toxin
• 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.
 Standardization of Churna
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:
• Organochlorine pesticide
• Organophosphorus pasticides
• Pyrethroids
 Standardization of Churna
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
• Additive sink to the bottom
• Burning candle burns brightly when placed in
or just above the Sandhana Paatra
 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
• Test for Methanol
• Total Acidity
• Chromatography
• 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
सुिक्वेतन्तुमत्वं स्यदवलेहोऽप्सु मज्जपत ।
पसपिित्वं िीडते मुद्रागन्धवर्ण िसोद्भवः ॥
1. Can be lifted in a spoon as treacle
2. When pressed between fingers, shows threadness when
stretched
3. Sinks in water without getting easily dissolved
4. Finger leaves impression on it
 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 standardization of
Tailas & Ghritas

वपतण वत्स्नेहकल्कः स्यादागुल्या पवमपदण तः।

शब्धहीनोऽपननपनपक्षप्तः स्नेहः पसध्दो भवेतदादा॥
यदा फेनोद्गमस्तैले िैनशापन्तश्च सपिण पर् ।
गन्धवर्ण िसोत्िपतदा स्नेहपसपध्दस्तदा भवेत् ।
• Sneha paka:
तुल्ये कल्केन पनयाण से भेर्जानां मदृ ु ः स्मत
ृ ः।
संयाव इव पनयाण से मध्यो दपवण पवमुन्चपत ।
शीयण मार्े तु पनयाण से वतण माने खिस्तिा।
 Parameters for standardization of
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. Gutika ( Guggulu) : 5 yrs
4. Rasa : 5yrs
5. Avaleha : 3 yrs
6. Asava & Arista : no expiry date.
Thank you