TOPIC 2 - PHILIPPINE PHARMACOPEIA

Dr. Patrocinio B. Valenzuela

The movement for the publication of a "Philippine Pharmacopeia" was initiated by the PPhA since the 1920s. Concrete steps were made during the presidency of

Pharmacopeial Monograph

usually contains basic chemical information for the ingredient, as well as its description and function (for food ingredients).

Pharmacopeial Monograph

contains detailed instructions for identification, purity tests and other specific tests to limit the amount of undesirable impurities, all of which may be used to verify common requirements by manufacturers and formulators concerned with the quality of their ingredients and products.

Name
Chemical name
Category
Description
Solubility

Monograph format

✓ Definition of the plant drug
✓ Clinical Applications
✓ Pharmacology ✓Contraindications
✓Warnings
✓ Precautions
✓ Potential adverse reactions ✓ Posology (Form of administration, duration of use)

Therapeutic Monograph

ESCOP

The European Scientific Cooperative on Phytotherapy

Quality control

can be defined as "part of quality management focused on fulfilling quality requirements".

Quality assurance

relates to how a process is performed or how a product is made

Pharmacopoeia

from the obsolete typography pharmacopœia, literally, "drug-making", in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

Dr. Jesusa A. Concha

also led the preparation and publication of the "Asian Pharmacopeia" in 1978

Philippine Pharmacists Association (PPhA)

PPhA

Federation of Asian Pharmaceutical Associations

FAPA

UP College of Pharmacy

Dr. Valenzuela and Dr. Concha served as officers of PPhA and FAPA and were former deans of the

General notices and requirements (Philippine Pharmacopeia)

provide the basic rules for the interpretation and application of the standards, tests, assays, and other specifications of the Philippine Pharmacopeia

LABORATORY TEMPERATURES

All temperatures in Philippine Pharmacopeia are expressed in degrees Celsius C and all measurements are made at 25 C

Deep Freeze

below -65 degrees celsius

In a freezer

below -10 degrees celsius

Cold

2 degrees celcius to 8 degrees celsius

Cool

8 degrees celcius to 15 degrees celsius

Room temperature

20 degrees celsius to 30 degrees celsius

CONCENTRATIONS

Molarity (M)
Normality (N)

Molarity (M)

is the number of moles of the designated solute contained in an amount of the designated solvent that is sufficient to prepare 1 liter of solution.

Normality (N)

is the number of equivalents of the designated solute contained in an amount of the designated solvent that is sufficient to prepare 1 liter of solution.

PERCENT MEASUREMENTS

1. Percent mass in mass (w/w)
2. Percent mass in volume (w/v)
3. Percent volume in volume (v/v)

Percent volume in volume (v/v)

Expresses the number of mL of a constituent in 100mL of solution or mixture.

Percent mass in volume (w/v)

Expresses the number of g of a constituent in 100mL of solution, and is used regardless of whether water or another liquid is the solvent.

Percent mass in mass (w/w)

Expresses the number of g of a constituent in 100g of solution or mixture.

SOLUTION

Where the name of the solvent is not stated, the term "solution" indicates a solution in water.

SOLUTION

Unless otherwise specified in the individual monograph, all solutions called for in tests and assays are prepared with USP Purified Water.

SOLUTION

An expression such as "(1 to 10)" means that the respective numbers means that 1 part by volume of a liquid is diluted with, or 1 part by mass of a solid is dissolved in sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume.

SOLUTION

An expression such as "(20:5:2)" mean that the respective numbers of parts, by volume. Of the designated liquids are to be mixed

SOLUTION

The notation "VS" after a specified volumetric solution indicates that such solution is standardized in accordance with the directions given in the individual monograph or under volumetric solutions in the section Reagents, Indicators, and Solutions as differentiated from solutions of approximate normality or molarity.

SOLUTION

Where a standardized solution of a specific concentration is called for in a test or an assay, a solution of other normality or molarity may be used, provided allowance is made for the difference in concentration and provided the error of measurement is not increased thereby.

CENTRIFUGE

the directions are predicated upon the use of apparatus having an effective radius of about 20cm and driven at the speed sufficient to clarify the supernatant layer within 15 minutes.

THERMOMETERS

Standardization of thermometers is performed according to established testing frequency with temperature standard traceable to US National Institute Standards.

WEIGHT AND BALANCES

Unless otherwise specified, when a substance is to be "accurately weighed" for Assay, the weighing is to be performed with a weighing device whose measurement uncertainty (random plus systematic error) does not exceed 0.01%

PHYSICAL MEASUREMENTS

Where an instrument for ________________ such as spectrophotometer, is specified in a test or assay by its distinctive name, another instrument of equivalent or greater sensitivity and accuracy may be used.

Internal diameter (ID)

for chromatographic tubes and columns, the diameter specified refers to

Outside diameter (OD)

for other types of tubes and tubing, the diameter specified refers to

PROCEDURE

Laboratories conducting assays or procedures prescribed in the Pharmacopeia should follow Good Laboratory Practices (GLP). When examined according to the test procedures described in this compendium, every compendia article commerce should be complied with all requirements described in the said monograph.

GLP

Good Laboratory Practices

FOREIGN SUBSTANCES AND IMPURITIES

Tests for the presence of _________________ are provided to limit such substances to amounts that are acceptable under conditions in which the article is customarily employed.

IDENTIFICATION

______________ tests are provided for the verification of the identity of the substance described in the monograph.

TESTS AND ASSAYS

are official methods upon which the standards of the Pharmacopeia depend.

Reference standards

are automatic specimens that have been verified for suitability as comparison standards in Pharmacopeial tests and assays.

INDICATORS

Where the use of test solutions (TS) as an ____________ is specified in a test or assay, approximately 0.2mL, or 3 drops of the solution shall be added, unless otherwise directed.

BLANK DETERMINATION

Where the __________________ is to be conducted, use the same quantities of the same reagent treated in the same manner as the solution or mixture containing the portion of the substance under assays or test, but with substance itself omitted.

TITRANT

Known concentration and volume

ANALYTE/TITRAND

Unknown concentration, known volume

CALCULATIONS OF RESULTS

The result of the assays should be calculated to one decimal place more than the indicated requirement and then rounded up or follows:

a.) If the last figure calculated is 5 to 9, the preceding figure is increased by 1.
b.) If it is 4 or less, the preceding figure is left unchanged.

REAGENTS

_____________ to be used conform to the specifications set forth in the current edition of Reagent Chemicals published by the American Chemical Society (ACS).

American Chemical Society

ACS

Reference standards

is referred to in an assay or test in this Pharmacopeia, the words "Reference Standards" are abbreviated to "RS"

DRYING OF CRUDE DRUGS

is usually done in shaded areas with adequate air circulation. Drying under the sun or drying by artificial heat in forced-draft ovens may be done at a temperature not exceeding 65 C.

DRYING OF CRUDE DRUGS

For household use, the crude plant drugs are spread out on flat surfaces and dried at room temperature with constant turning over to prevent rotting. If crud plant drugs have to be stored for future use, they must be dried and constantly checked for insect pests and fungal infestations.

DRYING OF CRUDE DRUGS

The Philippine climate is conductive to attacks by these pests and their prevention by the use of pesticide in the household is not recommended. Long-term storage of crude drugs is also not recommended.

CONTAINERS

-is the device that holds the article in the form of the raw material.
- The intermediate or primary container is that which is in direct contact with the article at all times. The container should be clean. No extraneous matter should be introduced into it or into the article placed in it.
- It must not interact physically or chemically with the article which it holds so as to alter the article's quality, purity, or therapeutic potency. Where available, environment-friendly container should be preferably used.

Well-closed Containers

- protects the contents from extraneous solids and loss of the article under ordinary or customary conditions of handling, shipment, storage, and distribution.

Tight Container

protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of article, and efflorescence, deliquescence, or evaporation under ordinary or customary conditions of handling, shipment, storage and distribution, and is capable of tight reclosure.

Hermetic Container

is impervious to air or any other gas under ordinary or customary conditions of handling, shipment, storage, and distribution.

Light-resistant Container

- protects the contents from the effects of light by virtue of the specific properties of the material of which it is composed, including any coating applied to it. Where it is directed "to protect from light" in an individual monograph, preservation in light resistant containers is intended.

Temper-evident Container

Shall be so sealed that containers cannot be used without obvious destruction of the seal.

ACCURATELY MEASURED AND ACCURATELY WEIGHED

Expression such as "25.00mL" and "25.0mg" used with respect to volumetric or gravimetric measurements indicate that the quantity is to be _________________ within the limits stated under Volumetric Apparatus (3012) or under Weighs and Balances (303).

ALCOHOL

- Where "Alcohol" or "Dehydrated Alcohol" is called for in formulas, USP "Alcohol" or "USP "Dehydrated Alcohol" may be used.

- Where "Alcohol" is called for in tests and assays, ACS reagent grade "Ethyl Alcohol" or USP "Alcohol" to be used.

- Where "Absolute or Anhydrous Alcohol" is called for in tests and assays ACS reagent grade "Absolute Ethyl Alcohol" or USP "Dehydrated Alcohol" is to be used.

CONTAMINANTLY

used in such expressions as "contaminantly determined" or" contaminantly measured" in directions for assays and tests, is intended to denote the determinations or measurements are to be performed in immediate successions.

CRUDE PLANT DRUG

refers to the drugs obtained from plants known medicinal value consisting of whole plants or anatomical parts thereof, which have not undergone any process or treatment other than what is essential to their property drying, packaging, and storage.

SPECIFIC GRAVITY

Unless otherwise stated, the ____________ basis is 25 C/25 C, i.e., the ratio of the mass of the substance in the air at 25 C to the mass of an equal volume of water at the same temperature.

DESICCATOR

-The expression "in a desiccator" specifies the use of a tightly closed container of suitable sizes and design that maintains an atmosphere of low moisture content by the presence of silica gel or other suitable desiccant.

vacuum desiccator

is one that maintains the low-moisture atmosphere at a reduced pressure of not more than 2.67kPA or at the pressure designated in the individual monograph.

DILUTION

Where it is directed that a solution be diluted "quantitatively and stepwise" an accurately measured portion is to be diluted by adding water or other solvent, in the proportion indicated, in one or more steps. The choice apparatus to be used should take into account the relatively larger errors generally associated with using small-volume volumetric apparatus.

DRYING TO CONSTANT MASS

The specification "dried to constant mass" means that the drying shall be continued until two consecutive weighings do not differ by more than 0.50 mg per g of substance taken (2.5 mg per g in case of crude plant drug), the second weighing following an additional hour of drying at the prescribed conditions.

FILTRATION

Where it is directed "filter" without further qualification, the intent is that the liquid is to be filtered through suitable filter paper or equivalent device until the filtrate is clear.

NEGLIBLE

This term refers to a quantity not exceeding 0.50mg

ODOR

Terms such as "odorless", "practically odorless", "a faint characteristic odor", or variations thereof, apply to examination after exposure to the air for 15 minutes, of either a freshly opened package.

PERCENT (%)

The term __________ used without qualification means, for mixtures of solids and semisolids, percent mass in mass; for solutions or suspensions of solids in liquids; percent mass in volume, for solutions of liquids in liquids, percent volume in volume. For example, a 1 percent solution is prepared by dissolving 1g of a solid or semisolid, or 1 mL of a liquid, in sufficient solvent to make 100 mL of the solutions.

POWDER FINENESS

The classification of _______________ in this Pharmacopeia expressed in descriptive terms is provided in the following table. For practical reasons, sieves are the preferred means of measuring powder fineness for most pharmaceutical purposes. Sieving is most suitable where a majority of the particles are larger than about 75 micrometers, although it can be used for some powders having smaller particle sized where methods can be validated

Sieves

are the preferred means of measuring powder fineness for most pharmaceutical purposes

Sieving

is most suitable where a majority of the particles are larger than about 75 micrometers, although it can be used for some powders having smaller particle sized where methods can be validated.

Very coarse

>1000

Coarse

355-1000

Moderately fine

180-355

Fine

125-180

Very fine

90-125

SOLUBILITY

The statements concerning the solubilities of Pharmacopeial substances are indicated by the descriptive terms

Very soluble

Less than 1

Freely soluble

1-10

Soluble

10-30

Sparingly soluble

30-100

Slightly soluble

100-1,000

Very Slightly soluble

1,000-10,000

Practically Insoluble or Insoluble

greater than 10,000

TIME LIMIT

If the conduct tests and assays, 5 minutes shall be allowed for the reaction to take place unless otherwise specified.

WATER

The water to be used in the tests of drugs shall be USP "Purified Water". Water used as an ingredient of official preparation meets the requirements for Purified Water, Water for Injection, or other sterile forms of water covered by a monograph.

WATER AND LOSS ON DRYING

Where the determination is made by drying under specified conditions, the test is generally given under the heading Loss on Drying from Crude Plant Drugs. This method determines the amount of volatile constituents of any kind that is removed during drying. For substances appearing to contain water as the only volatile constituent, the test is generally given under the heading Water (Water Determination).

WATER BATH

The term "heat on water bath" or "heat in a water bath" indicates, unless otherwise specified, boiling water in a water bath or in a steam bath about 100 C