Salient Features of IP-2018:
Keeping in view the essential requirement for harmonization of analytical methods with those accepted internationally, steps have been taken for monitoring drug standards.
- General Chemical tests & Thin Layer Chromatography (TLC) for identification of an article have been almost eliminated and more specific infrared, ultraviolet spectrophotometer and HPLC tests have been given emphasis. The concept of relying on published infrared spectra as a basis for identification has been continued.
- The use of chromatographic methods has been greatly extended to cope with the need for more specificity in assays and in particular, in assessing the nature and extent of impurities in ingredients and products.
- Most of the existing Assays and Related Substances Test methods are upgraded by liquid chromatographic in view to harmonize with other International Pharmacopoeia.
- Pyrogen test have been replaced by Bacterial Endotoxin test (BET) in parenteral preparations and other monographs.
- For ease of access to make Pharmacopoeia more user friendly, Index has been incorporated in Volume-I along with that already existing in Volume-IV of IP.
- 53 New Fixed Dose Combination (FDC’s) combination monographs have been included, out of which 25 FDC monographs are not available in any Pharmacopoeia.
- General Chapters on Volumetric Glassware, Conductivity, Dissolution test, Disintegration test, Dimensions of Hard Gelatin Capsule Shells etc. have been revised.
- For Controlling the Microbial quality of all the medicinal product general chapter on Maintenance, Identification, Preservation and Disposal of Microorganism have been revised. |
