The monograph in a pharmacopoeia are the treatises on drugs and formulations which give description, assay, assay limits and other details necessary for maintaining requisite standards.
A monograph in IP. includes the following.
- Title
- Chemical formula
- Atomic and molecular weight
- Definition
- Category
- Dose
- Usual strength
- Description
- Solubility
- Test methods
- Identification
- Tests and assay
- Limits
- Assay
- Storage
- Storage containers
- Labeling
- general information
- Title: The main title for a drug substance is the International Non-proprietary Name (INN) approved by World Health Organization (WHO). The official name of the compound in english is stated in the title. In place of the main title, sometimes sub titles are given which are synonyms/subsidiary names; where included, they have the same significance as the main title. For example, calcium carbonate can also be called precipitated chalk; iron and ammonium citrate can also be called ferric ammonium citrate.
2. Chemical formulae: When the chemical structure of an official substance is known or generally accepted, the graphic and molecular formulae are normally given at the beginning of the monograph for information. To specify the absolute stereo chemical configuration International Union of Pure and Applied Chemists (IUPAC) systems have been used.
3. Atomic and molecular weight: The atomic and molecular weights are shown, as and when appropriate at the top right hand corner of the monograph. For example, magnesium chloride (Molecular weight: 202.30).
4. Definition: The opening statement of a monograph is one that constitutes an official definition of the substance, preparation or other article that is the subject of the monograph.
5. Category: This part of the monograph expresses the pharmacological or therapeutic or pharmaceutical application of the compound. Although the compound may have other applications usually this part describes the main application. Analgesics, antibiotics, antacids, laxatives etc. are some of the main categories for inorganic pharmaceuticals in the Pharmacopoeia.
6. Dose: Dose mentioned in the Pharmacopeia is intended merely for general guidance and represent, unless otherwise stated, the average range of quantities which are generally regarded as suitable for adults when administered by mouth. It provides the quantity guidance to the prescriber or the physician to achieve the desired therapeutic effects in adults. The dose can be altered as and when required. For example the dose of calcium carbonate is 1 – 5 gm.
7. Usual strength: It indicates the strength(s) usually marketed for information of the pharmacist and the medical practitioner.
8. Description: It illustrates a physical description of the substance such as amorphous nature or crystalline, odour, colour and taste etc. In the preliminary evaluation of the integrity of an article these properties help the standards in tests for purity.
9. Solubility: The solubility mentioned in Indian Pharmacopeia is the approximate solubility at a temperature between 15 °C and 30 °C. Different degrees of solubility are.
| Very soluble | In less than 1 part |
| Freely soluble | In 1-10 parts |
| Soluble | In 10-30 parts |
| Sparingly soluble | In 30-100 parts |
| Slightly soluble | In 100-1000 parts |
| Very slightly soluble | In 1000-10,000 parts |
| Insoluble | In more than 10,000 parts |
10. Test methods: References to general methods of testing are indicated by test method numbers in brackets immediately after the heading of the test or at the end of the text.
11. Identification: This usually involves specific chemical test or tests for identifying the substance. In general for inorganic pharmaceuticals, colour reactions, precipitation reactions and gas evolving reactions are used. For example, phenol gives violet colour with ferric chloride.
Some identification tests include :
Simple chemical tests leading to formation of colour or precipitates
Infrared absorption spectroscopy
Ultraviolet – visible spectroscopy
Melting point or Boiling point
12. Tests and assay: These are the official methods upon which the standards of Pharmacopoeia depend. The requirements are not framed to take into account all possible impurities. Tests and assays are prescribed for the minimum sample available on which the attributes of the article should be measured.
13. Limits: These are tests designed to identify and control small quantities of impurities which are likely to be present in a substance. The limits given are based on data obtained in normal analytical practice. They take into account normal analytical errors, of acceptable variations in manufacture and of deterioration to an extent that is acceptable. No further tolerances are to be applied to the limits for determining whether or not the article under examination complies with the requirements of the monograph.
14. Assay: An assay gives in detail the analytical method for the substance in order to determine the percentage content of a particular chemical in the given test sample. The reagent required for assays and tests are defined in the appendices showing their nature, degree of purity and strengths of solutions.
15. Storage: The storage directions are useful in preserving the activity of the chemical. The terms used are well closed container, light resistant container, single dose container. I.P. also prescribes conditions for storage.
| Cold | Between 2-8°C |
| Cool | Between 8°C – 25°C |
| Room temperature | Temperature of working area. |
| Warm | 30-40°C |
| Excessive heat | Above 40°C |
16. Storage containers: The storage containers in the Pharmacopoeia are indicated in the following terms :
Well closed containers: This implies the substance is stable and gets protected from dust, dirt, insects etc, getting into the container.
Tightly closed container: The substances in such cases get affected by atmospheric oxygen or moisture or carbon dioxide.
Light resistant container: Substances which are affected by light are stored in amber or dark colored containers.
Single dose containers.
17. Labeling: The labeling of drugs and pharmaceuticals is governed by the Drugs and Cosmetics Rule, 1945. The statements that are given in the monographs under the side heading “labeling” are not comprehensive.
18. It contains general information. For example, the IP. 1985 have the following appendix:
| Appendix No. | Contents |
| Appendix No. 1 | Apparatus for test and assay. e.g., Volumetric flask, thermometer etc. |
| Appendix No. 2 | Biological tests and assays |
| Appendix No. 3 | Chemical tests and assays |
| Appendix No. 4 | Microbiological tests and assays |
| Appendix No. 5 | Physical tests and determinations such as pH, melting point, etc. |
| Appendix No. 6 | General information |