This document discusses the standardization of Ayurvedic formulations. It explains that standardization involves quantifying the purity, quality, identity and constituents of drugs and formulations. For churnas (powders), both Ayurvedic and modern parameters are used for standardization, including organoleptic evaluation, microscopy, physical analysis, phytochemical analysis, and testing for contaminants. Similar parameters are discussed for standardizing other formulations like asavas, arishtas, avalehas, vatis, gutikas, tailas, ghritas and arka. Shelf life testing is also important for ensuring formulations remain within approved specifications when stored properly.
2. 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.
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3. • Identity : biological source of drug
• Quality : Active constituents
• Purity : extent of foreign materials
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4. 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.
5. 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.
7. 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
15. 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
16. 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
17. Acid Value
• The acid value is the number of mg of
Potassium hydroxide required to neutralize the
free acid in 1gm of substance.
19. Parameters for standardization of
Avaleha
सुिक्वेतन्तुमत्वं स्यदवलेहोऽप्सु मज्जपत ।
पसपिित्वं िीडते मुद्रागन्धवर्णिसोद्भवः ॥
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
20. Parameters for standardization of
Avaleha
• Organoleptic
• Physical
• Reducing sugar
• Total sugar
• Chromatography
• Test for heavy metals
• Microbial contamination
• Shelf life
21. 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
22. Parameters for standardization of
Vati & Gutika
• Organoleptic Parameters :
1. colour
2. Odour
• Total sugar
• Reducing sugar
• Phytochemical assessment
23. Parameters for standardization of Vati
& Gutika
• Particle size
• Identification : Microscopy , HPTLC & TLC
• Test for Heavy metals & toxins
• Microbial contamination
• Pesticide residue
24. 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
25. 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
29. • 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
32. Parameters for standardization of
Tailas & Ghritas
• Organoleptic : colour, odour
• Weight /ml
• Viscosity
• Iodine value
• Saponification
• Acid value
• Rancidity : fat oxidization
33. Iodine Value
• The iodine value of substance is the weight of
iodine absorbed by 100 part by weight of
substance .
• Applicable for liquid substances.
34. 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.
35. Parameters for standardization of
Arka
• Organoleptic
• Physical : pH, Volatile matter, SG, Clarity test
Sterility test
• Chromatography
• Self life
36. 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