Qualitative Approach in Quality Control of Homoeopathic Medicine

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Qualitative Approach in Quality Control of
Homoeopathic Medicine Dr. D.R.
Lohar Director Department of AYUSH Homoeopathic
Pharmacopoeia Laboratory, Ministry of Health
Family Welfare, GHAZIABAD
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HOMOEOPATHY WORKS ON THE PRINCIPLE OF SIMILIA
SIMILIBUS CURANTUR True Homoeopathic Drugs act
at Molecular and at energy levels and not at
physiological as other system does.
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HOMOEOPATHIC MEDICINES Rule 2 (dd) of Drugs and
Cosmetics Rules 1945 Include any drug which is
recorded in Homoeopathic provings or therapeutic
efficacy of which has been established through
long clinical experience as recorded in
authoritative literature of India and abroad and
which is prepared according to the techniques of
homoeopathic pharmacy and covers combinations of
ingredients of such homoeopathic medicines but
does not include a medicine which is administered
by parenteral route.
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• QUALITY CONTROL CAN BE DONE AT THE LEVEL
• _____________________________________
• Of raw materials,
• Of manufacturing process,
• Of finished products and
• Of storage and packaging

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HOMOEOPATHIC MEDICINES DERIVED FROM
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BROADLY HOMOEOPATHIC MEDICINES CAN BE DIVIDED IN
THE FOLLOWING CATEGORIES
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PREPARATION OF MOTHER TINCTURE

• FRESH DRUGS By MACERATION
• Takes generally two to three weeks
• DRY DRUGS By PERCOLATION
• Takes 24 48 Hours

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HOMOEOPATHIC POTENCIES, LIQUID BY SUCCUSSION
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HOMOEOPATHIC POTENCIES SOLIDS BY TRITURATION
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BIOCHEMIC DRUGS TWELVE TISSUE SALTS
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• CHEMICAL DRUGS
• PHYSICO-CHEMICAL PROPERTIES
• Crystalline Nature
• Solubility
• Melting point / Boiling point
• Specific Optical Rotation
• Refractive Index
• Loss on Drying
• Ash Value
• Acid insoluble
• Sulphated ash

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• CHEMICAL DRUGS
• viii. Viscosity
• Surface Tension
• UV Light Absorptions
• Light Diffraction
• Chemical Tests
• Assay

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TESTING OF BIOCHEMICS AND TRITURATION
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ATOMIC ABSORPTION SPECTROSCOPY Molecules
Atoms Molecules absorb in UV light Atoms absorb
characteristic light of one frequency generated
from the lamp of same element (HCL) No other
element interfere in the analysis Absorption of
light is proportional to the concentrations of
that element.
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ATOMIC ABSORPTION SPECTROSCOPY Range - All
metallic elements (193-800 nm) Sensitivity -
Flame analysis 10-6 (ppm) - Graphite furnace
10-9 (ppb) Source of Flame - Acetylene / Air
2200oC - Acetylene/Nitrous oxide
2900oC Source of Light - Hollow cathode lamp -
Electrodes discharge lamp - Single element /
multi element
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• PARAMETERS CAN BE STUDIED
• Absorbance, Concentration, Emission
• - Wave length Control
• Hollow Cathode lamp
• Monochromatic wave length setting

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HCL
DETECTOR
MONOCHROMATOR
SAMPLE
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• TESTING OF MOTHER TINCTURE
• Alcohol Content
• pH Value
• Weight per ml
• Total Solids
• Identification
• a. Colour reactions for constituents
• b. Chromatography-thin layer, paper with
• reference standards
• 6. UV Absorbance

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• CHROMATOGRAPHY
• Thin layer chromatography
• Paper chromatography
• Gas liquid chromatography
• High pressure liquid chromatograph

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• TESTING OF GLOBULES
• Pharmaceutical Grade Cane Sugar
• Size of the Globules
• Ash Value
• Absence of Foreign matters
• Hardness
• Porosity
• Solubility

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SCHEDULE- FF OPTHALMIC PREPERETIONS

• Name quantity of preservatives
• Should be used within one month after opening
• Should be sterile,
• Should be isotonic,
• Neutral or acidity within limit
• Warnings as per schedule -FF

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DIACARD/GOLD DROPS

• Alcohol content,
• Test for ether,
• Test for ingredients,
• Test for gold content

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TESTING OF HAIR OIL

• Test for vegetable oil-arachis oil,
• Test for mineral oil,
• Test for acid value,
• Test for saponification value,
• Test for iodine value,
• Test for ingredients by TLC,
• Test for stability,

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Testing of Ointments

• Test for homogeneity,
• Test for consistency,
• Test for ingradients by TLC,
• Alcohol contents,
• Ash value

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LABELLING PACKING OF HOMOEOPATHIC MEDICINES

• Rule 106-A
• Homoeopathic medicine
• Name of Medicine
• a. Pharmacopoeial name as given
• Homoeopathic Pharmacopoeia of India,
• German Homoeopathic Pharmacopoeia
• Homoeopathic Pharmacopoeia of UK or
• US Homoeopathic Pharmacopoeia
• b. For other drugs, Descriptive name

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PACKAGING AND LABELLING OF HOMOEOPATHIC
MEDICINES 3. Potency in decimal, centesimal and
millisimal (in case of two or more medicines,
potency and percentage of each ingredients in
metric system). 4. Name and address of
Manufacturer or seller. 5. Alcohol percentage in
volume, for packing bigger than 30 ml., 6. Batch
No. and Manufacturing license No. 7. Single
ingredient shall not bear proprietary name on its
label.
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• RULE 106-B
• Homoeopathic medicine having more than 12
  Alcohol shall be packed in 30 ml only.
• For Hospitals/Dispensaries 100 ml packing is
  allowed.

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STANDERDS PUBLISHED
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Thank You