Pharmaceutical Analysis
• It is the series of processes that are used for identification, determination, separation,
purification, and structure elucidation of the given compound used in the formulation of
pharmaceutical products.
• The components, to which the pharmaceutical analysis is done, are normally active
pharmaceutical ingredients, pharmaceutical excipients, contaminants present in
pharmaceutical products, or drug metabolites.
Emphasis is placed on discussing the principle of quantitative pharmaceutical chemistry and the
different methods of analysis employed so students will be able to apply this concept in establishing
the quality and purity of raw materials, food, drugs and drug products to ensure the health of the
society
According to RA 10918
Pharmaceutical products refer to drugs, medicines, biologicals, pharmaceutical and
biopharmaceutical products/ specialties, veterinary products, veterinary biologies and veterinary
medicinal products;
Drugs refer to pharmaceutical products that pertain to chemical compounds or biological
substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease
in hiunans or animals, including the following.
Active Pharmaceutical Ingredient (API)
- Any substance intended to be used in the manufacture of a medicinal product and that, when so
used, becomes an active ingredient of the medicinal product.
Accdg to European Pharmacopeia :
- An herbal medical product is a medicinal product, exclusively containing as active ingredients one
or more herbal drugs or one or more herbal drug preparations, or one or more such herbal drugs in
combination with one or more such herbal drug preparation.
- An excipient any constituent of a medicinal product that is not an active substance. Adjuvants,
stabilizers, antimicrobial preservatives, diluents, antioxidants, for example, are excipients.
Pharmaceutical quality assurance (QA)—Sum of all activities and responsibilities required to ensure
that the medicine that reaches the patient is safe, effective, and acceptable to the patient
Pharmaceutical quality control—Process concerned with medicine sampling, specifications, and
testing, and with the organization’s release procedures that ensure that the necessary tests are
carried out and that the materials are not released for use, nor products released for sale or supply,
until their quality has been judged satisfactory
Poor quality medicines do not meet official standards for
✓Strength
✓Quality
✓Purity
✓Packaging
✓Labeling
