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3-Standardardization of Ayurvedic Formulation

This document outlines the standardization parameters for various Ayurvedic formulations including churna, asava, arishta, avaleha, vati, gutika, taila, and ghrita. It discusses evaluating the identity, quality, purity, and other characteristics of the formulations such as organoleptic properties, microscopy, physical properties, phytochemistry, particle size, microbial contamination, toxins, pesticides, and shelf life. The standardization helps ensure the formulations meet requirements for safety, efficacy and consistency.

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Mamta Pant
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3K views28 pages

3-Standardardization of Ayurvedic Formulation

This document outlines the standardization parameters for various Ayurvedic formulations including churna, asava, arishta, avaleha, vati, gutika, taila, and ghrita. It discusses evaluating the identity, quality, purity, and other characteristics of the formulations such as organoleptic properties, microscopy, physical properties, phytochemistry, particle size, microbial contamination, toxins, pesticides, and shelf life. The standardization helps ensure the formulations meet requirements for safety, efficacy and consistency.

Uploaded by

Mamta Pant
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
  • Introduction to Standardization of Ayurvedic Formulations: An overview of the importance and meaning of standardization in Ayurvedic formulations, focusing on identity, quality, and purity.
  • Standardization of Churna: This section covers various methods used for the standardization of Churna, including organoleptic, microscopic, physical, phytochemical evaluations, and more.
  • Standardization of Asava and Arishta: Details the parameters for standardization of Asava and Arishta, including organoleptic and physical evaluations.
  • Standardization of Avaleha: Outlines the methods for standardization of Avaleha with a focus on physical and microbial evaluations.
  • Standardization of Vati and Gutika: Describes parameters for Vati and Gutika including physical and pharmaceutical evaluations and microbial tests.
  • Standardization of Tailas and Ghritas: Covers the standardization methods for Tailas and Ghritas focusing on organoleptic properties and various chemical values.
  • Standardization of Arka: Discusses the parameters for Arka standardization emphasizing physical and chromatographic tests.
  • Shelf Life Assessments: Provides an assessment of shelf life factors affecting Ayurvedic formulations and regulatory guidelines.
  • Conclusion: The concluding section acknowledging the completion of the document.

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

2
3
•
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

Standardization ofAyurvedic formulations
Standardization Standardization of drug means confirmation of its identity and determination of its quality and purity. 2 • I
• Organoleptic evaluation • Microscopic evaluation • Physical analysis • Phytochemical analysis • Particle size • Test for he
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 e
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 • T
Standardization of Churna Pesticide residue: Methods : Extraction & Purification Pesticides to be detected: • Organochlorine
Parameters for Standardization of Asava AndArishta Ayurvedic parameters : • Clear liquid without any forth • Pleasant arom
Parameters for Standardization of Asava AndArishta • Organoleptic evaluation • Physical evaluation:- pH, Specific gravity a

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