QUALITY CONTROL OF CRUDE DRUGS WITH SPECIAL REFERENCE TO

THEIR QUALITY AND PURITY

SINGH S. 1* AND SHARMA V. 2
1, SRMS College of Pharmacy, Bareilly, U.P-India
2, MJP, Rohilkhand University, Bareilly, U.P-India

ABSTRACT
A crude drug is any naturally occurring, unrefined substance derived from organic or
inorganic sources such as plant, animal, bacteria, organs or whole organisms intended
for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or
other animals. Quality control of herbal medicines is a tedious and difficult job. Herbal
medicines differ from that of the conventional drugs and so some innovative methods
are coming into being for the sake of quality assessment of herbal drugs. The present
paper deals with the quality control parameters of the crude drugs which will focus its
quality and purity.

* Corresponding Author

INTRODUCTION
A crude drug is any naturally occurring, unrefined substance derived from organic or
inorganic sources such as plant, animal, bacteria, organs or whole organisms intended
for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or
other animals. Crude drugs are unrefined medications in their raw or natural forms.
Raising, harvesting and selling crude drugs were how many large pharmaceutical
companies started out. Quality control of herbal medicines is a tedious and difficult job.
Herbal medicines differ from that of the conventional drugs and so some innovative
methods are coming into being for the sake of quality assessment of herbal drugs. The
traditional herbal medicines and their preparations have been widely used for thousands
of years. One of the characteristics of herbal medicine preparations is that all the herbal
medicines are incorporated into an extractor at the same time and extracted with boiling
water during the decoction process. In this process, a variety of interactions between the
active components of several herbal medicines may occur. This is the main reason why
quality control of oriental herbal drug is more difficult than that of western herbal drug.
In this paper, we would like to present an overview of the characteristics of regulation
and quality control of herbal medicines.

ESSENTIAL STANDARDS
Harvesting
In addition to geo-authenticity, we harvest at the proper time of the year to maximize
the active ingredients potency.
Identification
A Master Herbalist macroscopically examines the herbs to ensure they are the proper
species and grade of herb that we desire, and that the herbs are from the highest quality
of its species. Extra steps such as TLC tests and microscopic tests are also taken. The
2005 Chinese pharmacopoeia and European standards for each herb is the guideline.
Processing
All herbs are furthered processed according to traditional techniques at our PIC/S
(Pharmaceutical Inspection Cooperation / Scheme) GMP Certified Plant to ensure the

highest effectiveness and decrease the potential of side effects. The GMP quality
assurance system protects the whole manufacturing procedure, and documentation
ensures that every step of manufacturing is traceable. Products are chosen randomly
from each lot for testing.
Testing
Each batch of herbs is dual-lab tested by our in-house lab and independent third party
lab. Our in-house lab is equipped with instruments such as a high performance liquid
chromatograph, moisture determination meter, Fourier transform infrared spectrometer,
atomic absorption spectrophotometer, gas chromatograph, etc.
In addition, the following additional tests are performed:
Microbacteria
Pesticides - over 200 pesticides tested for (Uab 2000 screen).
Heavy Metals - Lead, Mercury and Arsenic
Packaging and Storage
Processing and storage standards make the difference in preserving the quality of our
herbs. Our herbs have a shelf life of 24-36 months. Our natural herbs retain their
freshness and quality without added preservatives. Special measures are taken to store
the herbal materials to maintain their optimum required conditions for humidity,
temperature and protection from light.
The growth of pharmaceutical industry is based on continuing success in producing
new products whether they are used as therapeutic or prophylactic agents. The role of
R&D is pivotal in this endeavor.
Pharmaceutical research is aimed at meeting the medical needs of the population for
whom appropriate therapeutic remedies are not available or at those that are available
are unsafe for prophylactic use for various disorders. While meeting medical needs,
research also has to ensure that market needs for such exist and that the product will
command sales and profits proportionate to investments. In cases where there are
mismatches between these two, the products suffer the status of orphan drugs. The
selection of an appropriate R&D portfolio is a strategic management exercise for a

company, which should take into account apart from medical needs, innovative
potential for success and available resources.
WHO GUIDELINES FOR QUALITY STANDARDIZED
1. Quality control of crude drugs material, plant preparations and finished
products.
2. Stability assessment and shelf life.
3. Safety assessment; documentation of safety based on experience or
toxicological studies.
4. Assessment of efficacy by ethnomedical informations and biological activity
evaluations.
The standardization of crude drug materials includes the following steps:
Authentication (Stage of collection, parts of the plant collected, regional status,
botanical identity like phytomorphology, microscopical and histological analysis,
taxonomical identity, etc.)
Foreign matter (herbs collected should be free from soil, insect parts or animal
excreta, etc.)
Organoleptic evaluation (sensory characters taste, appearance, odor, feel of the drug,
etc.)
Ash values and extractive values.
Moisture content determination
Chromatographic and spectroscopic evaluation.
TLC, HPTLC, HPLC methods will provide qualitative and semi quantitative
information about the main active constituents present in the crude drug as chemical
markers in the TLC fingerprint evaluation of herbals (FEH). The quality of the drug can
also be assessed on the basis of the chromatographic fingerprint.
Determination of heavy metals e.g. cadmium, lead, arsenic, etc.
Pesticide residue WHO and FAO (Food and Agricultural Organization) set limits of
pesticides, which are usually present in the herbs. These pesticides are mixed with the

herbs during the time of cultivation. Mainly pesticides like DDT, BHC, toxaphene,
aldrin cause serious side-effects in human beings if the crude drugs are mixed with
these agents.
Microbial contamination usually medicinal plants containing bacteria and molds are
coming from soil and atmosphere. Analysis of the limits of E. coli and molds clearly
throws light towards the harvesting and production practices. The substance known as
afflatoxins will produce serious side-effects if consumed along with the crude drugs.
Radioactive contamination Microbial growth in herbals are usually avoided by
irradiation. This process may sterilize the plant material but the radioactivity hazard
should be taken into account.
CONCLUSIONS
India can emerge as the major country and play the lead role in production of
standardized, therapeutically effective ayurvedic formulation. India needs to explore the
medicinally important. Chemical and instrumental analyses are routinely used for
analyzing synthetic drugs to confirm its authenticity. In the case of crude drugs,
however the scene is different especially for polyherbal formulation, as there is no
chemical or analytical method available. Therefore biological-screening methods can be
adopted for routine checkup of herbal drugs and formulations. In the case of crude
drugs, the quality of raw materials and products can be furnished by regular
pharmacognostic identifications and phytochemical analysis. The stability parameters
which includes physical parameters, chemical parameters, and microbiological
parameters. Physical parameters include color, appearance, odor, clarity, viscosity,
moisture content, pH, disintegration time, friability, hardness, flowability, flocculation,
sedimentation, settling rate and ash values. Chemical parameters include limit tests,
extractive values, chemical assays, etc. Chromatographic analysis of herbals can be
done using TLC, HPLC, HPTLC and GC, UV, Fluorimetry, GC-MS, etc. Hence these
are all the essential quality control measures to be adopted for the maintainance of the
quality and purity of the crude drugs.
REFERENCES
1. Soderlund Pharmacy Museum; Soderlund Pharmacy Museum
2. United States Dispensatory 1907
3. Eli Lilly Artifact 1916

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5. Ayurvedic Pharmacopoeia
6. Indian Herbal Pharmacopoeia
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8. Rajpal, Standarization of Herbals
9. Mukherjee P. (2001). Quality Control of Herbal Drugs.