This document discusses quality control and standardization of crude drugs. It describes various techniques used to evaluate crude drugs including macroscopic and microscopic examination to identify diagnostic characteristics. It also discusses chemical evaluation through qualitative and quantitative methods like chromatography and spectroscopy. Physical evaluation techniques like moisture content, ash values and biological assays are also summarized. The purpose of quality control is to confirm identity and purity of drugs and detect adulteration.

1. Pharmacognosy &
Phytochemistry-I
BP305TP Practical
B. Pharm. Sem 3
June-Dec 2021 Batch
L. M. COLLEGE OF PHARMACY

2. Practical -1:
Macroscopical and Microscopical
Qualitative evaluation of Powdered
Drugs:
Diagnostic characters (Tissues and cell
contents)
A.Quality control of Drugs of
Natural Origin:
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3. DRUG EVALUATION
• Means
 confirmation of its identity and
 determination of its quality and purity and
detection of nature of adulteration.
• It is necessary b’coz:
1) Geographical and Biochemical variation in the
drug
2) Deterioration due to treatment and storage
3) Substitution and adulteration, as a result of
carelessness, ignorance or fraud.
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4. Adulteration
• The term 'adulteration' or debasement of an
article covers a number of conditions, which
may be deliberate or accidental. Usually in
crude drugs, this practice includes
substitution of the original crude drugs
partially or fully with other substances which
is either free from or inferior in therapeutic
and chemical properties.
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5. EXAMPLES OF
ADULTERATION
- Pieces of limestone are
found in asafoetida
- Mineral oil in coconut
oil
- Powdered bark is
frequently found to be
adulterated with brick
powder L. M. COLLEGE OF PHARMACY

6. EFFECT OF USING DRUGS WITHOUT QC
• It may not possess the therapeutically active
constituents
• It even may be having some toxic compounds
that may not only affect the efficacy of the
finished product but also cause deleterious
effect on human health.
• Reliability of the finished product is at
national and international level is affected
and betraying the faith of people on the
Indian System of Medicine.
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7. Quality Control / Standardization
of Crude drugs
General techniques:
1) Morphological and Organoleptic evaluation
2) Microscopic evaluation
3) Chemical evaluation
4) Physical evaluation
5) Biological evaluation
Evaluation of crude drug (entire form or
powdered form) to confirm its identity and
ensure its quality and purity
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8. QC
Crude drug
(entire form)
Organized
drug
Unorganized
drug
Powdered
drug
Powdered
Organized
drug
Powdered
Unorganized
drug
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9. 1) Morphological OR Organoleptic Evaluation
• The study of form/external characters of
crude drug is called MORPHOLOGY.
• Refers to evaluation of a drug by colour, odor,
taste, size, shape and special features like
touch, texture etc.
• It’s a technique of qualitative evaluation
based on the study of morphological and
sensory profiles of whole drugs.
• Organoleptic evaluation means conclusions
drawn from studies resulted due to impressions
on organs of senses.
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10. E.g. Crude drug : e.g. Diagnostic characters
1. Entire form- organized or unorganized:
qualitative evaluation by shape and
organoleptic characters
E.g.
- Disc-shaped structure of Nux-vomica seed
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11. - Twisted-shape of
rauwolfia root
(Sarpagandha)
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-Compound quills of
Ceylon Cinnamon bark
-Conical shape of
Aconite root

12. - Ovoid tears of gum
Acacia
- Ribbon-shape of
Tragacanth gum
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13. E.g. Diagnostic characters:
Organoleptic characters
- Sweet taste of Liquorice root
- Pungent taste of capsicum
- Brick-red color of bark drugs (cinnamon,
cinchona)
- Aromatic odor of Umbelliferous fruits
(Fennel, Coriander)
- Odor and taste of spice-drugs: asafoetida,
cardamom, black pepper, cumin, etc.
2. Powdered form- organized or unorganized:
qualitative evaluation by specific organoleptic
characters only
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14. 2) Microscopic Evaluation
• Allows more detailed examination of a drug
under a microscope
• Can be used to identify the organized drugs by
their known histological characters
• Mostly used for qualitative evaluation of
organized crude drugs in entire and powdered
forms
• Histological studies are made from very thin
sections of drug (entire forms) or powder
slides (powdered forms)
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15. • The characteristics /types of cells and tissues
and their arrangement (lignified tissues like
stone cells, trichomes, stomata, fibres)
• The characteristics /types of cell contents
(starch grains, calcium oxalate crystals)
• Microscopic evaluation does not apply
to unorganized drugs, unless they are
adulterated with some organized
drugs.
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16. e.g. Diagnostic microscopical characters:
For Organized drug (entire and powder
both)
- Lignified trichomes in nux-vomica
- Warty trichomes of senna
- Sessile Glandular trichome of mint
- Powdered cloves do not contain
sclereids/Stone cells but they are
present in powdered clove stalks
- Powdered clove fruits show presence of
starch, while it is absent in clove bud.
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18. Powder characteristics of
senna leaf

19. Powder characteristics of
Mentha leaf

20. Starch grains in ginger

21. Detailed study of some microscopical
characteristics:
1. Stomata- Definition, Types, Examples, role
in drug evaluation
2. Trichomes- Definition, Types, Examples, role
in drug evaluation
3. Plant tissues- Types, characteristics and
functions
4. Cell content- Definition, Types, Examples,
role in drug evaluation
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22. • Quantitative microscopy: Involves
measurements (counting and linear measurements).
• Various parameters studied are (for both entire and
powdered organized drugs):
- Leaf constants (Stomatal number and index,
Palisade ratio, Vein-islet number, Vein termination
number): e.g. Senna varieties are distinguished by
differing stomatal number and palisade ratio.
- Size and number of starch grains – E.g. Ginger
- Number of sclerenchymatous cells per square mm
of cardamom is useful for detecting different
varieties of cardamom seed.
- Length of fibers – E.g. Cinnamon, Cinchona.
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23. 3. CHEMICAL EVALUATION
• Comprises of different chemical tests
(qualitative) and chemical assays
(quantitative).
• The qualitative chemical tests (preliminary
phytochemical screening) are useful for
identification of drugs and for detection of
adulteration.
• The purity of crude drug is ascertained by
quantitative estimation of active chemical
constituents present in them.
• Useful in determining single active
constituent or the group of related
constituents present in the same drug.
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24. Assay Methods:
Chromatographic Techniques
– Thin layer chromatography (TLC)
– High performance Thin layer
chromatography (HPTLC)
– Gas liquid chromatography (GLC)
– High performance liquid chromatography
(HPLC)
– Column chromatography
– Gel permeation chromatography
– Affinity chromatography
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25. Assay Methods:
Spectroscopic Methods
i) Ultra-violet and Visible Spectrophotometry
ii) Infra Red Spectoscopy
iii) Nuclear Magnetic Resonance Spectroscopy
(NMR)
iv) Mass spectrometry
v) X-Ray Diffraction
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26. 4. PHYSICAL EVALUATION/
Proximate analysis
i) Moisture
content
ii) Viscosity
iii) Melting point
iv) Solubility
v) Optical rotation
vi) Refractive index
vii) Ash values
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viii) Extractives
values
ix) Volatile oil
content
x) Swelling index
xi) Bitterness index
xii) Hemolytic index
xiii)Foreign organic
matter

27. 5. BIOLOGICAL EVALUATION
• When the estimation of potency of crude
drug or its preparation is done by means of
its effect on living organisms like bacteria,
fungal growth or animal tissue or entire
animal, it is known as BIOASSAY.
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This method is generally
called for, when
standardization is not
adequately done by chemical
or physical means and also
for confirmity of therapeutic
activity of raw material.