Shelf Life Period According to Acharyas mentioned in Samhitas in Ayurvedic Context as well as Modern Basics of Packaging labelling and Storage has been Discussed in it.

1. Dr. Hari aumshree Nair
PG SCHOLAR
Dept. of Rasa Shastra and Bhaishajya Kalpana
1

2.  Ayurvedic therapeutic system includes various types of
dosage forms, depending upon the consistency and shelf
life, such as vati, churna (as solid dosage forms); Swarasa,
asava , arishta, kashaya, hima (as liquid dosage form) and
kalka, avaleha (as semi- solid dosage form).
 In Ayurvedic literatures, ‘Saviryata avadhi’ term is
mentioned in context of the time period during which the
virya / guna of any drug remains unaffected due to
environmental / microbial deterioration.
2

3.  Acharya Sharangadhara, first mentioned about Saviryata
Avadhi of various formulations that is known as Shelf life,
expiry date or stability in the modern system of medicine.
 Saviryata avadhi of a formulation depends upon three
main things i.e. Ingredients, preparation and form.
 However in the beginning, it was ignored due to
developmental stage of pharmaceutics, utilization of drug
instantly, lack of mass production and unavailability of
equipment's.
3

4.  In contemporary system, the term ‘Shelf Life’ is used to indicate the
time period during which an API (Active Pharmaceutical Ingredient)
or FPP (Finished Pharmaceutical Product) is expected to remain
within the approved stability specification, provided that it is stored
under the conditions defined on the container label.
 In the present scenario, the pharmaceutical sector has tremendously
changed. Product safety, efficacy and ethical issues in stability
testing has increased a lot, making an inter- disciplinary science
where in addition to analytical criteria, pharmaceutical,
technological, biochemical and biotechnological criteria have
become more important.
4

5.  Concept of Saviryata avadhi was not explained by any Acharyas
until 13th century, later Acharyas like Vangasena, Sharangadhara and
Yogaratnakara where the ones who had explained about the shelf
life period of various ayurvedic dosage forms.
 According to need, various formulations were designed which over
the period of time were tested for their effectiveness and depending
on these observations life span of drugs i.e. period for which it can
protect its own gunas were calculated which was termed as
saviryata avadhi of medicine.
5

6. “ GUNAHINAM BHAVEDVARSADURDHVAM TADRUPAMAUSADHAM,
MASADVAYATTATHACURNAM HINAVIRYATVAMAPNUYAT.
HINATVAM GUTKALEHAU LABHETE VATSARATPARAM,
HINASYURGHRTA TAILADYASCATURMASADHIKATTATAH.
AUSADHO LAGHU PAKASYURNIRVIRYA VATSARATPARAM,
PURANASYURGUNAIRYUKTA ASAVA DHATAVO RASAH ”
- CHAPTER- SS - l. 51-53
 Word virya represent here the potential of a drug to give a desired action
or karma which is nothing but its guna. This period up to which a
specific medicine can possess its gunas / virya unchanged was termed as
saviryata avadhi of medicines.
6

7. DOSAGE
FORM
Vangasen
(12th century)
Sharangdhara
(13th century)
Yogaratnakar
(17th century)
KWATHA, KALKA,
SWARASA
- - 3 Hours
ANJANA - - 3 months
CHURNA - 2 months 3 months
VATI - 12 months -
GUDA / AVALEHA
12 months 12 months 6 months
GHRITA , TAILA
6 months 16 months 12 months
ASAVA, DHATU,
RASA
PREPARATION
- Long-term stability -
7

8. 1. Churna, Kwatha Churna 2 years 2 years
2. Gutika
(Vati-Gutti, Pills, Tablets except Gutika with Rasa) 3 years (explained in S. No. 37)
3. Gutika Tablet containing Kasth aushadhi, 3 years
4. Gutika, Tablet containing Kasth aushadi
and Rasa, Uprasa, Metallic Bhasmas, and Guggulu. 5 years
5. Rasaushadhies No expiry date (explained in S. No. 38)
6. Asava-Arista No expiry date 10 years
7. Avaleha 3 years 3 year
(Includes Khanda, Paka, Guda also)
8. Guggulu 5 years 5 years
9. Mandura - Lauha 10 years 10 years
10. Ghrita 2 years 2 years
11. Taila 3 years 3 years
12. Arka 1 year 1 year 8

9. 13. Dravaka, Lavana, Ksara 5 years 5 years
14. Lepa Churna 3 years 2 years
15. Dant Manjan Powder 2 years 2 years
16. Dant Manjan Paste 2 years -
17. Lepa Guti 3 years (explained in S. No. 37)
18. Lepa Malahar (Ointment)
/Liniment/ Gels/lotions /creams 3 years Malahar - 3 years
19. Varti 2 years (one time use) 2 years
20. Ghana Vati 3 years (explained in S. No. 37)
21. Kupipakva Rasayan No expiry date 10 years
22. Parpati No expiry date 10 years
23. Sveta parpati 2 years 2 years
24. Pisti and Bhasma No expiry date Pishti and Bhasma except Naga,
Vanga and Tamra Bhasma – 10 years9

10. 25. Svarna, Rajata, Lauha, Mandura,
Abhraka bhasma, Godanti, Shankha Bhasma, etc. No expiry date (explained in S. No. 24)
26. Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 5 years2 5 years
27. Capsules made of soft gelatin (
depending upon the content material) for Kashtha aushadhi 3 years -
28. Capsules of hard gelatin
(depending upon the content material) –
containing Kasth aushdhi with Rasa, Bhasma, Parad-Gandhak 5 years -
29. Syrup/liquid oral 3 years -
30. (Karna/Nasa Bindu) Ear/Nasal drops 2 years 2 years
31. Eye drops 1 year 1 year
32. Khand/Granule/Pak 3 years (explained in S. No. 7)
33. Dhoopans-Inhalers 2 years 2 year
34. Pravahi Kwatha (with preservatives) 3 years Pravahi Kwatha- 3 years10

11. 35. Anjana -
a) Anjana made from Kasthaushadhi 1 year
b) Anjana made from Kasthaushadhi along with Rasa/Uprasa/Bhasma 2 year
c) Anjana made only from Rasa/Uprasa/Bhasma 3 year
36. Sharkar / Panak/Sharbat 3 year
37. Gutika/Vati -
(I) Gutika or Vati containing Kasthaushadhi along with Rasa /
Uprasa / Bhasma/ Guggulu (including Lepa Gutika and Ghan Vati) 5 years
(II) Gutika or Vati containing only Kasthaushadhi
(including Lepa Gutika and Ghan Vati) 3 years
(III) Gutika / Vati containing only Ras /Uprasa /
Bhasma except Naga, Vanga and Tamra Bhasma 10 years
38. Rasayoga -
(I) Rasayoga containing only Rasa / Uprasa /
Bhasma except Naga, Vanga and Tamra Bhasma 10 years
(II) Rasayoga containing Rasa / Uprasa/ Bhasma
along with Kasthaushadhi/Guggulu 5 years
39. Sattva (derived from medicinal plant) - 2 years 11

12. 12

13.  As per the reference in Charaka samhita, a drug should be packed
in a Bhajana (container) which has anurupa guna that is the
packaging material should not interfere with the physical,
chemical or biological property of the drug which is packed
inside.
 Also there are references that the churna, taila etc should be stored
in Kalash and also kept in dark places and should be stored air
tight. Because if there is unsatisfactory packaging permits it will
lead to a faster degradation of the product.
13

14.  Any packaging must possess sufficient quality so that it
can conquer the mechanical hazards like Shock,
compression, vibration etc. and environmental hazards
like temperature, moisture, light, infestation,
contamination and exposure to oxygen.
 In the present era, by the advancement in techniques of
design and development of packaging, the materials are
having barrier properties to build stability for the
formulations.
14

15.  Various packaging medias are present depending upon the
product inside which includes metal foils especially
aluminium, plastics, glass bottles with closures, tin packs,
collapsible tube, rubber, paper and board.
 For photosensitive drugs, there are amber glass which
screen out UV radiations very effectively.
15

16. S.NO DRUG NATURE
TYPE OF SPOILAGE
POSSIBLE
MEANS OF INHIBITION
IN VOGUE
1. Raw drug
- Insect infestation, Microbial
decomposition self decomposition
Air drying
2. Asavas &
Aristas
Fermentation product Microbial decomposition Kashayams are sterilized by heating,
organic acids sugars and alcohol
present act as preservatives
3. Arkas Distillates Loss of volatile oil through
evaporation
-
4. Curna Herbal drugs in powder from
with or without salts and sugars
Insect infestation, Microbial
decomposition self-decomposition
No Satisfactory means
5. Ghrtas &
Tailas
Solution in ghee or oil of oil
soluble principles extracted from
herbal drugs
Self-decomposition Possible natural antioxidant activity of
fat soluble principles
6. Guggulu Resin with vegetable ingredients
or with inorganic ingredients
Microbial decomposition, self
decomposition -
7. Kwatha
curna
Mixed powder of herbal drugs
for preparation of water extracts
Insect infestation microbial
decomposition, self decomposition
No satisfactory means
8. Vati, gutika,
varti,
netrabindu
Pills, tablets containing
vegetable and mineral drugs
Microbial decomposition, self
decomposition
No satisfactory means
9. Bhasmas,
Rasa
ausadhas
Predominantly mineral
preparations - Mostly stable
16

17. 17

18.  Preservatives are chemical agents which serve to retard, hinder or
mask microbial damage. They are of two categories : (i) Natural
products, both organic and inorganic, (ii) synthetic compounds.
 The Natural Preservatives such as cinnamon, lemon juice,
rosemary extract, vinegars, citric acid, sodium chloride; sugars,
spices and essential oils from spices.
 Artificial preservatives used in food and drug are sodium and
calcium propionates, caprylic acid, sorbic acid and sorbates;
benzoid acid and benzoates; derivatives of benzoic acid such as
the parabens; sulphur dioxide and sulphites, sodium nitrite.
 Artificial preservatives are not used in the Indian systems of
medicine, their possible application will be a useful subject for
investigation.
18

19. 19

20. S. NO CATEGORY TRADITIONAL METHOD OF STORAGE EXPERIMENTALLY FINDINGS
1. Asavas and
Aristas
They are kept in well stoppered bottles or jars Can be kept indefinitely tightly stoppered bottles
2. Arka
-
Should be preserved in tightly closed container to prevent
loss of volatile matters and kept away from light.
3. Avalehas, leha &
Paka
Kept in glass or porcelain jars, also in metal
containers which do not react.
Glass containers most suitable No deterioration upto a
months.
4. Guggulu Kept in glass or porcelain jars free from
moisture and stored in a cool place.
Stays fresh for only 2 months, kept in glass jars.
5. Kwatha curna Kwatha curna retains potency for one year.
Kept in air-tight containers.
Can be preserved for 4 months only, free or insect
infestation. Packed in glass containers, develop rancidity by
3rd month.
6. Ghrta Are preserved in glass, polythene or
aluminium containers.
Packed in glass containers, develop rancidity by 3rd month.
7. Curna Powders should be at least 80 mesh fine free
from moisture. Kept in air tight containers.
Keeps good quality for at least 6 months, packed in glass or
polythene containers.
8. Tailas Are preserved in glass, polythene or
aluminium containers.
Becomes rancid by 3rd months, packed in glass bottle.
9. Dravaka They are preserved in glass stoppered bottles.
- 20

21. S. NO CATEGORY TRADITIONAL METHOD OF STORAGE EXPERIMENTALLY FINDINGS
10. Lavana Ksara Should be kept in air tight bottles. It kept in air tight containers could be
preserved for long duration.
11. Lepa Vegetable lepa curna will retain potency for 30 days if
kept in air tight containers. Mineral and metallic
preparations last in-definitely .
Shelf life study of lepa in curna form
showed it could be preserved for 3 months
only free from insects.
12. Vati gutika Pills made of plant drugs kept in air tight containers Vati-gutika containing plant drugs can be
preserved for 6 months, in glass containers.
13. Varti- Netra bindu
Anjana
Kept in air tight container. Can be preserved for 6 months in glass
container.
14. Sattva Can be preserved in closed containers.
15. Kupipakva
Rasayana
To be kept in well stoppered bottles. Can be stored indefinitely
16. Parpati Preserve their potency indefinitely, kept in glass bottles.
-
17. Pisti Stored in glass stoppered bottles. Can be stored indefinitely
18. Bhasma Preserved in air tight glass or earthern containers. Can be stored indefinitely
19. Mandura Should be kept away from moisture. Can be stored indefinitely
20. Rasayoga Keep their potency indefinitely. Can be stored indefinitely
21. Lauha When well protected from moisture and heat, keep their
potency for a period of 2 years. Preparations containing
Hg keep their potency indefinitely.
Can be stored indefinitely
21

22.  Parabens -
 Parabens are a class of widely used preservatives in cosmetic
and pharmaceutical products. These compounds, and their
salts, are used primarily for their bactericidal and fungicidal
properties.
1. Butyl paraben -
 It is an organic compound with the formula C11H14O3. Butyl
paraben is proven to be a highly successful anti-microbial
preservative in cosmetics. This act as both bactericidal as well
as fungicidal preservative. The popularity is due to its effective
antimicrobial properties, in particular those against mold and
yeast.
22

23. 2. Ethyl paraben -
 Its chemical formula is C9H10O3. This preservative is used as an
antifungal agent. Its E number is E214. If used in excess it may
cause skin irritation, contact dermatitis and rosacea. On the
skin may react with UVB leading to increased skin ageing and
DNA damage. Ethyl paraben act as xenoestrogen.
3. Methyl paraben -
 Its chemical formula is C8H8O3. It is the methyl ester of p-
hydroxybenzoic acid. This act as an anti-fungal agent. Methyl
paraben is considered generally recognized as safe (GRAS) for
food and cosmetic antibacterial preservation. Maximum
permitted level is 0.4%. This gets readily absorbed from the
gastrointestinal tract or through the skin. It is hydrolyzed to p-
hydroxybenzoic acid and rapidly excreted in urine without
accumulating in the body. 23

24. Benzoic Acid -
 Chemical formula of benzoic acid is C6H5COOH. This is a
colourless crystalline solid and a simple aromatic carboxylic
acid. E- Number of benzoic acid is E210. Its maximum
permitted level is 0.1%. This inhibits the growth of mold, yeast
and some bacterial species.
Sodium benzoate -
 Chemical formula of sodium benzoate is C6H5COONa or
C7H5NaO2. It is the sodium salt of benzoic acid. E Number of
sodium benzoate is E211.Maximum permit-ted level is 0.1%.
One gram of sodium benzoate is soluble in 2 ml of water, 75 ml
of ethyl alcohol and 50 ml of 90 % ethyl alcohol.
 Sodium benzoate is safe for consumption within the range 647-
825 mg / kg of body weight /day. This is used as an
antimicrobial agent in medicines which naturally are in the pH
range below 4.5. 24

25.  Metabolism Of Sodium Benzoate -
 Sodium benzoate which we intake get transported to liver.
Within mitochondria of hepatocytes it combine with
coenzyme A to form benzoyl coenzyme A. Benzoyl
coenzyme A combine with glycine to form hippuric acid.
Hippuric acid is finally excreted through urine. Average
excretion is about 0.7g/day.
25

26.  SIDE EFFECTS -
 Research work published in 2007 for the UK's Food Standards
Agency (FSA) suggests that certain artificial colours, when
paired with sodium benzoate, may be linked to hyperactive
behaviour. Ascorbic acid (vitamin C) when used along with
sodium benzoate, we get benzene, which is a known
carcinogen. In some persons sodium benzoate may produce
nausea and vomiting. Because of structural similarities between
benzoate and salicylates, exacerbation of peptic ulcer, mild
hyperventilation, and mild respiratory alkalosis may develop.
Hypernatremia is possible, especially in patients with
diminished renal function.
26

27.  Stability is the capability of a specific formulation in a
particular container/closure system to remain within its
physical, chemical, microbiological, toxicological,
therapeutic specifications, and is always expressed in
terms of shelf life.
 The shelf life of a product can be defined as the time
duration up to which it is expected to retain 90% of its
active ingredients (label claim) when stored in
recommended condition.
27

28.  The purpose of stability testing is to provide evidence of
how the quality of a pharmaceutical product changes with
time due to impact of a variety of environmental factors,
namely, temperature, humidity and light and product-
related factors, namely, container closure system and
packaging materials.
 Currently, there are 2 guidelines namely ICH and WHO
guidelines that provide sufficient details regarding
parameters on which stability study can be done.
28

29. STABILITY CHAMBER
29

30. 1. Accelerated testing - In accelerated stability testing, the product
is subjected to a several high temperatures, humidity, light intensity,
etc., that accelerates degradation and the amount of heat required to
degrade the product is determined so as to predict the shelf life. This
concept is based upon Arrhenius equation that describes the
relationship between storage temperatures and deterioration rate.
{ log k = log Z – E / 2.303 R X 1 / T }
2. Real time (long-term) testing - It is normally performed for
longer duration to allow significant degradation of the product
under specified storage conditions. 30

31. 3. Intermediate testing - These are mainly conducted when the
accelerated studies for general case failed to meet the acceptance
criteria and are designed to moderately increase the rate of
degradation for a drug intended to be stored long-term at 25°C.
4. Stress testing - It includes the effect of temperature (above that
used in accelerated study), humidity (e.g., ≥75% RH), oxidation,
photolysis and hydrolysis.
5. Forced degradation testing - It is performed with objective to
provide intrinsic stability assessment of the drug, to elucidate the
possible degradation pathways by identifying the likely degradation
products and to have an idea of the stability of the analytical process
applied for the drug. 31

32. IAM
STABLE
PHYSICAL
CHEMICAL
MICROBIOLOGICALTHERAPEUTIC
TOXICOLOGICAL
32

33. 33

34. INTENDED
STORAGE
CONDITION
STABILITY
TEST
METHOD
TEST TEMPERATURE
AND HUMIDITY
(PERIOD IN
MONTHS) AS PER
ICH
TEST TEMPERATURE
AND HUMIDITY
(PERIOD IN MONTHS)
AS PER THE WHO
Room temperature Long term
Intermediate
Accelerated
25±2°C/60±5% RH (12)
30±2°C/65±5% RH (6)
40±2°C/75±5% RH (6)
25±2°C/60±5% RH or
30±2°C/65±5%RH or
30±2°C/75±5% RH (12)
30±2°C/65±5% RH (6)
40±2°C/75±5% RH (6)
Refrigerated Long term
Accelerated
5°C/ambient (12)
25±2°C/60±5% RH (6)
5±3°C
25±2°C/60±5% RH or
30±2°C/65±5% RH
Freezer Long term −20°C/ambient (12) −20°C±5°C
STABILITY TESTING STORAGE CONDITIONS FOR DRUGS
(As per ICH and WHO)
34

35. 35

36. METHOD AND
CLIMATIC ZONE
ENVIRONMENT TIME POINTS FOR
SAMPLING
Long term for climatic
Zones I and IV
25°C/60% RH 3, 6, 9, 12, 18, 24, 36 months
Long term for climatic
Zones III
30°C/35% RH 3, 6, 9, 12, 18, 24, 36 months
Long term for climatic Zone
IVa /intermediate for Zones I
and II
30°C/65% RH 3, 6, 9, 12, 18, 24, 36 months
Long term for climatic Zone
IVb /intermediate for Zones
I and II
30°C/75% RH 3, 6, 9, 12, 18, 24, 36 months
Accelerated condition for all
zones
40°C/75% RH 3, 6 months
TEST SCHEDULE FOR STABILITY TESTING OF NEW
PRODUCTS
36

37. 1. SELECTION OF BATCHES AND SAMPLES - In general, this
selection should constitute a random sample from pilot or production
batches that may involve a single batch or 2-3 batches.
2. TEST ATTRIBUTES - The tests that monitor the quality, potency,
purity, and identity that are expected to vary upon storage are chosen as
stability tests.
3. ANALYTICAL PROCEDURES - Procedures given in the official
compendia should be followed and if alternate methods are to be used,
they need to be duly validated.
4. ACCEPTANCE CRITERIA - This should be fixed beforehand in the
form of statistical limits for the results manifested in computable terms
and pass or fail for qualitative tests.
5. STORAGE CONDITIONS - These are based upon the marketing
climatic zone of the drug. 37

38. 6. STORAGE PERIOD - It generally extend from minimum of 3 or 6
months in accelerated and stress testing and up to 12, 18, or 60 months
in on going or follow-up stability testing.
7. TESTING FREQUENCY - It should be sufficient to establish the
stability profile of the drug.
8. SAMPLING PLAN - It involves devising for the number of samples
to be placed in the stability chambers and taking out of the charged
batch so as to cover the entire study.
9. CONTAINER CLOSURE SYSTEM - The testing in actual
containers as well as closures scheduled for marketing, are to be tested
separately with proper orientation of storage of containers.
10. EVALUATION - The data on quantitative attribute is analysed to
determine the time duration at which 95% one-sided confidence limit
for the mean curve intersects the acceptance criterion.
11. STATEMENTS, LABELING - A storage statement, retest period,
and re-test date based on the stability evaluation of the drug substance
should be established for the labelling. 38

39.  Acc. to Acharya Sharangadhara, the shelf life of churna is 2 months and
then gradually starts depreciating.
 Acc. to D & C rule 2005, the Official Gazette of India notified shelf life of
churna as 1 year, but recent amendments of August 2016 shows its shelf life
as 2 years, while AFI has also mentioned it to be 1 year.
 In Ayurvedic formulation for churna, due to multi drug component in many
of the formulations it is difficult to choose the expiry date so it is preferable
to give a “Best Before Use Date” as this is the date after which one or more
properties of any drug or drug substances have shown considerable changes,
which can be seen or perceived by the consumer or patients and may lead to
doubts about the quality of the product and its efficiency.
39

40.  PHYSICAL FACTORS -
 TEMPERATURE – rates of chemical reactions increases with
rise in temperature
 MOISTURE – moisture absorbed on the surface of a solid drug
will often increases the rate of decomposition if it is susceptible
for hydrolysis
 LIGHT – a drug can affect chemically by radiation of a
particular wavelengths only if it is absorbs the radiation at that
wavelength and the energy exceeds the threshold. 40

41.  CHEMICAL FACTORS -
 HYDROLYSIS
 OXIDATION & REDUCTION
 BIOLOGICAL FACTORS -
 EXPOSURE TO MICROBES – due to herbo – mineral
combination in churnas, the active principles in the form of
phytochemical properties helps to increases the microbial
activity
 OTHER FACTORS -
 Undesirable interaction between two or more drugs are said to
result in physical or chemical or therapeutical incompatibility.
41

42.  PHYSICAL PARAMETERS -
 Organoleptic characters
 Loss on drying at 105O c / Moisture content
 Particle size
 Flowability – bulk density, tap density
 CHEMICAL PARAMETERS -
 Extractive values – water soluble and alcohol soluble
 Ash value – total ash, acid insoluble ash, water soluble ash
 TLC / HPTLC
 MICROBIOLOGICAL PARAMETERS -
 Total viable count
 Yeast & mold count
 Coliform count and other pathogens 42

43.  One important difference is evident in the concepts as Ayurveda gives
importance to type of formulation to decide the Saviryata avadhi and
consider chemical composition of drug as a secondary parameter. In modern
medicine chemical composition of a drug is given more importance and
different expiry dates are decided for different drugs depending on their
chemical stability.
 Basis of difference are the drugs as In modern medicine, they are pure
chemical compounds of one type which has a well defined structural
composition, on basis of which its stability can be predicted, while In case of
Ayurveda drugs, they are a mixture of many chemical components which
interact with each other and also with environment so it is not possible to
decide its stability on the basis of its one constituent. 43

44.  According to Ayurveda every drug is panchabhautika in nature.
Various samskaras which are mentioned in Ayurvedic Kalpanas
have their role in extension of shelf life.
 Stability of drug depends on panchabhautika composition of it,
Prithvi and jala mahabhuta are responsible for maintaining it in
yatha sthiti. Increase in agni and vayu mahabhuta composition of
dravya enhances speed of degeneration of drug by augmenting
processes of digestion and decomposition.
taoYaaMsaMyaaogaivaBaagao parmaaNaUnaaM k arNaM
vaayau: k ma-svaBaavaEca ||
(ca. Saa. 7 | 17 )
44

45.  Ayurvedic lexicon as well as Gazette notification regarding shelf life of Ayurvedic
formulations specified by Government of India is silent about the guidelines
regarding methodology to be followed for estimation of the same.
 International Conference on Harmonization guidelines details out the methods of
quality assessment parameters as a means of evaluating shelf life which should be
applied to ASU drugs also.
 Assessment of shelf life of Ayurvedic formulations nowadays should be based on
various test attributes given in PLIM, Ghaziabad Protocol. It seems nearly
impossible to conduct real-time stability study of Ayurvedic formulations having
longer shelf life such as rasa preparations, asava arishta, but extrapolated shelf life
can be calculated for these based on 10% degradation method using accelerated
stability testing, so as to scientifically support ancient Ayurvedic claims regarding
shelf life. 45

46.  Unfortunately, all available analytical parameters enlisted for
Ayurveda formulations in various manuals such as A.P.I., A.F.I. and
others are from the point of Quality control and Standardization.
Ayurvedic approach towards developing the parameters based on
the panchabhautika assessment are currently not established. In this
scenario approach of Ayurveda should be of two types -
1. Using available parameters of quality control for the
analysis
2. Designing newer techniques which suit principles of
Ayurveda by adopting advances in Instrumentation if possible.
 Efforts in both of these directions are done in analytical study. 46

47. 47