Pharmacopoeia Editions Pharmaceutics-I.pptx

PPT

1. HISTORY OF PHARMACOPOEIA Ms. Sneha B Hukkeri Assistant Professor Dept. Pharmaceutical Chemistry

2. Pharmakon- a drug; poeia - to make It is a book of directions and requirement for the preparation of medicine. It is a legislation of a country which sets standards and obligatory quality indices for drugs, raw materials used to prepare them and various pharmaceutical preparations.

3. Monograph: It is a complete description of a specific pharmaceutical, which includes nomenclature, classification, physical characteristics, dosage form, purity, limits for impurities, identification assay and conditions for storage.

4. DIFFERENT TYPES OF PHARMACOPOEIA United states Pharmacopoeia Indian Pharmacopoeia British Pharmacopoeia European Pharmacopoeia French Pharmacopoeia

5. Every country has legislation on pharmaceutical preparations that sets standards and obligatory quality indices for medicaments, raw materials and preparations employed in the manufacture of drugs. The first USP was released on 15 th Dec 1820. The first BP was published in 1864. It was including monographs on benzoic acid, gallic acid, tartaric acid, tannic acid, camphor, lactose, sucrose and seven alkaloids with their salts.

6. Pharmacopoeial Description / Presentation Introduction: S ummarizes the various changes/additions/deletions in the current edition. Monograph of Official Drugs, Preparations and substances: Information of single drug which are arranged in the alphabetical order of their names. It includes the following: 1. Title: Stated in English-official name of the compound, sometimes synonyms Ex: Calcium carbonate – precipitated chalk Iron and ammonium citrate- ferric ammonium citrate Milk of magnesia – magnesium hydroxide

7. 2. Formula weight and molecular weight: Ex: MgCl ₂. 6H₂O Mo. Wt - 202.30 Not given- indefinite composition or correct chemistry is not known Ex: Iron ammonium citrate 3. Category: Therapeutic or pharmacologic or pharmaceutical application of the compound. Ex: Antacid, astringent 4. Dose: Quantities for the guidance of prescriber or physician to achieve the desired therapeutic effects. EX: CaCO ₃ - 1-5gm

8. 5. Description: Physical description like crystalline / amorphous, color, odor, taste. Ex: CaCO ₃- Fine, white, microcrystalline, odorless and tasteless. 6. Solubility: Water, hot water, alcohol, glycerol, ether or other organic solvents.

9. 7. Standard: It specifies the quantitative purity of the compound. Definite composition: Ex: Potassium bromide- Not less than 98% of KBr. Not definite composition: Ex: Bentonite (hydrated aluminium silicate), Dried aluminium hydroxide gel: Hydrated aluminium oxide (varying small quantities of aluminium carbonate and bicarbonate) not less than 47% of aluminium oxide. 8. Identification: Chemical test or identifying test, color reactions, precipitating test, gas evolving reactions. Ex: Phenol + FeCl ₃ ------ Violet color. 9. pH: Manufacturing pharmacist to develop dosage forms to avoid physical complications. Ex: Calcium amino salicylate 2% w/v-------6-8 pH

10. 10. Limits for impurities: Specific impurities (phosphates, sulphides , arsenic, heavy metals, chloride, lead (%). 11. Assay: Step by step description of analytical method. Inorganic: Titrimetric and gravimetric methods are used. 12. Storage: Directions to preserve chemicals. 13. Appendices: General notices and monographs are followed by appendices.

11. INDIAN PHARMACOPOEIA COMMISSION (IPC) On behalf of the Ministry of Health and Family welfare, Government of India in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940, Dangerous Drugs Act 1930 and Poisons Act 1919 and the rules framed thereunder. Head office is in Ghaziabad (UP)

12. INDIAN PHARMACOPOEIA Before independence - BP was used as official book of standards. Secretary of IP Committee – Issue amendments 1948- Govt of India constituted a permanent Indian Pharmacopoeia Committee for the preparation of IP to keep it up to date.

13. EDITION YEAR Volumes SUPPLEMENT/ ADDENDUM 1 st edition 1955 - Supplement 1960 2 nd edition 1966 - Supplement 1975 3 rd edition 1985 2 Addendum 1989 Addendum 1991 4 th edition 1996 2 Addendum 2000 Vet supplement 2000 Addendum 2002 Addendum 2005 5 th edition 2007 3 Addendum 2008 6 th edition 2010 3 Addendum 2012 7 th edition 2014 4 Addendum 2015 Addendum 2016 8 th edition 2018 4 Addendum 2019 Addendum 2021 9 th edition 2022 4

14. Salient features 1 st edition (1955) Monograph 986 Title of monograph Latin language Weight and measures Metric system Doses Metric and English system List of preparations Given at the end of some of the monographs Abbreviated Titles used Solubility Descriptive terms instead of exact solubility

15. 2 nd edition (1966) Monograph 93 new monographs added Title of monograph Latin to English language Solubility Parts of solvent per unit part of solute. Techniques New analytical techniques included Test Sterility test modified to detect fungi

16. 3 rd edition (1985) Monograph 260 new monographs added and 450 were amended New analytical techniques Flame, photometry, electrophoresis, fluorometry, dissolution, Gas liquid chromatography had been recognized Test Microbial limit tests prescribed for liquid preparation Viscosity Modified involving use of Ostwald viscometer

17. 4 th edition (1996) Volumes 2 Volume 1 Notices, prefaces, acknowledgements, introduction, general notices, Monographs (A-O) Volume 2 Monographs (P-Z), IR spectra, appendices, index Monograph 1149 and 123 appendices in two volumes 44 new monographs 110 were deleted Drug identification tests Infrared and ultra violet absorption spectrophotometric tests Analytical method HPLC was used Test Bacterial endotoxin was introduced Veterinary supplement 208 monographs and 4 appendices

18. 5 th edition (2007) Volumes 3 1 st volume General notices, structure of IPC, introduction and general chapters 2 nd and 3 rd volume General monographs on dosage forms, drug substances and pharmaceutical aid Chemical test General-eliminated IR and UV spectrophotometric test - included Test for pyrogen Animals- eliminated Bacterial endotoxin- included Abnormal toxicity test Confined to certain vaccines only Labelling and storage Given at the end of monographs Limit Bacterial contamination included