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
Reasons of Pharmaceutical crimes:
● availability of substandard and counterfeit drugs in disturbing proportion in many low- & middle-
income countries (LMIC)
● lack of reliable drug quality assurance systems in many developing countries

Determinants of Medicine Quality

● Identity: Active ingredient
● Purity: Not contaminated with potentially harmful substances
● Potency: Usually 90–110% of the labeled amount
● Uniformity: Consistency of color, shape, size
● Bioavailability: Interchangeable products?
● Stability: Ensuring medicine activity for stated period

Identity, purity, potency, uniformity are defined in pharmacopoeias and stated in certificate of
analysis (COA)

Who Ensures Medicine Quality?

● Drug regulatory authority
● Drug and therapeutics committee
● Hospital procurement office
● Patients
● Pharmacy
● Physicians and other prescribers

Legal basis of pharmaceutical analysis

● RA 10918 Philippine Pharmacy Act - Section 2. Statement of Policy.
- The State recognizes the vital role of pharmacists in the delivery of quality health care
services through the provision of safe, effective, and quality pharmaceutical products,
pharmaceutical care, drug information, patient medication counseling, and health
promotion.
● RA 3720 Food, Drug, and Cosmetic Act - Chap. 2, sec. 2 & 3
- An act to ensure the safety and purity of foods, drugs, and cosmetics being made available
to the public by creating the food and drug administration which shall administer and
enforce the laws pertaining thereto
● RA 9711 FDA Act of 2009 - Section 3
- an act strengthening and rationalizing the regulatory capacity of the bureau of food and
drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading its
equipment, augmenting its human resource complement, giving authority to retain its
income, renaming it the food and drug administration (FDA), amending certain sections of
republic act no. 3720, as amended, and appropriating funds thereof
Application of the procedures of qualitative and quantitative analytical chemistry
● To the analysis and determination of the purity and quality of drugs and chemicals used in
pharmacy
● To the analysis of the chemical constituents found in the human body whose altered
concentrations during disease states serve as diagnostic aids
● To the analysis of medicinal agents and their metabolites found in biological systems

What is quality?
- Sum of all factors which contribute directly or indirectly to the safety, effectiveness, and reliability
of the product
- Ensures that drug products are designed and produced to meet or exceed customer requirements
for effect and safety

What is Quality Control?

- It is a tool which gives the assurance that a product conforms to standards and specifications
through a system of
- inspection,
- analysis and
- action.
Quality control guarantees within reasonable limits that a drug product is:
✔ free of impurities
✔ physically and chemically stable
✔ contains the amount of active ingredients as stated in the label
✔ provides optimal release of active ingredients when the product is administered

Potential benefits derived from a QC system:

● Minimization or elimination of marketing unsafe products
● Guaranteed conformance to regulatory requirements
● Guaranteed product efficacy
● Reduction of operating costs
● Reduction of operating losses
● Produces higher employee morale
● Motivation of the pharmaceutical/medical professions to sell or prescribe the product
Quality assurance for quality drugs
Shewart cycle
considered a project planning tool,
it is a four-step model for carrying
out change; should be repeated
again and again for continuous
Improvement

Goals of Medicine QA Programs

To make certain that each medicine reaching a patient is safe, effective, and of standard
quality
● Obtaining quality products that are safe and effective through structured selection and
procurement methods
● Maintaining quality products through the appropriate storage, distribution, monitoring,
and use by prescribers, dispensers, and consumers