Indian pharmacopoeia

The USP 28 [1], European Pharmacopoeia [2], BP 2003 [4], and Indian Pharmacopoeia 1996 [7] use the liquid chromatography method as described above in Section 2.2.2 for the assay of oxytetracycline. The International Pharmacopoeia 1988 [5], Pharmacopoeia of the People s Republic of China [6], Indian Pharmacopoeia [7], and Indonesian Pharmacopoeia [8] use a microbiological method. This methodology will be described in more detail in a later section. 

Materials Required Arsenic limit test apparatus HgCl2—paper smooth white filter paper (having thickness in mm of 400 paper = weight in g per Sq. M.), soaked in a saturated solution of HgCl2, pressed to get rid of excess of soln. and dried at about 60°C in the dark lead acetate solution 10.0% w/v soln. of PbAc2 in C02 free water KI (AsT), 1.0 g Zn (AsT) 10.0 g Dilute Arsenic solution (AST) Standard stains, Test Solutions—are prepared according to the Indian Pharmacopoeia 1996. 

Unlike national (such as British Pharmacopoeia, Indian Pharmacopoeia or US Pharmacopoeia) and regional (such as European Pharmacopoeia) pharmacopoeias, The International Pharmacopoeia has, a priori, no determined legal status, but WHO Member States are free to adopt it and to incorporate it into national legislation, either in part or in whole. The first edition was published in two volumes (1951 and 1955). The latest fourth edition of The International Pharmacopoeia was published in 2006 and an update is to be published in 2008. 

When following the procedure established by the Indian Pharmacopoeia 1996 [13], about 0.1 g of analyte is accurately weighed and dissolved in 15 mL of warm 95% ethanol (previously neutralized to phenolphthalein solution). One adds 20 mL of water and titrates with 0.5 M NaOH using phenolphthalein solution as the indicator. Each milliliter of 0.5 M NaOH titrant is equivalent to 0.06106 g of benzoic acid. 

The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia. 

Eudragit RS 100, RSPM, S 100 and L 100 were received by courtesy of Rohm Pharma GmbH, Darmstadt, FRG. Theophylline (Indian Pharmacopoeia), polyisobutadiene, acetone, trichloroethylene, cyclohexane and methylene chloride were procured commercially. 

Indian Pharmacopoeia, Indian Pharmacopoeial Commission, Ghaziabad, 2007, pp. 749-751. 

Anonymous, 1966. Indian Pharmacopoeia , 2nd edition. Ministry of Health and Family Welfare, Govt of India, New Delhi. 

According to USP 26 [1] and the Indonesian Pharmacopoeia [4], mefenamic acid is specified to contain not less than 98.0% and not more than 102.0% of C15H15NO2, calculated on the dried basis. The substance is to be preserved in tight, light-resistant containers. The British Pharmacopoeia 2002 [2], European Pharmacopoeia [5] and Indian Pharmacopoeia [6] describe that mefenamic acid contains not less than... 

According to USP 26 [1], Indonesian Pharmacopoeia [4], Indian Pharmacopoeia [6], and Pharmacopoeia of the People s Republic of China [7], mefenamic acid capsules are specified to contain not less than 90.0% and not more than 110.0% of the labeled amount of Ci5H15N02. According to the British Pharmacopoeia 2002 [3], mefenamic acid capsules and tablets are specified to contain not less than 95.0% and not more than 105.0 percent of the stated amount of the substance. 

Identification testing according to the Indian Pharmacopoeia [6] is performed by means of three tests (denoted as tests A, B, and C). 

According to the British Pharmacopoeia 2002 [2] and Indian Pharmacopoeia [6], mefenamic acid in capsule and tablet preparations are identified by examination using infrared absorption spectrophotometry as the following procedure. Extract a quantity of the capsule contents (or powdered tablets) containing 0.25 g of mefenamic acid with two 30 mL quantities of ether. Wash the combined extracts with water, evaporate to dryness on a water bath, and dry the residue at 105°C. Dissolve a sufficient quantity in the minimum volume of absolute ethanol, and evaporate to dryness on a water bath. The infrared absorption spectrum is concordant with the reference spectrum of mefenamic acid. 

When examined according to the British Pharmacopoeia 2002 general procedure (2.4.14), as well as the procedure of the European and Indian Pharmacopoeias, the sulfated ash obtained for an acid sample may not exceed 0.1%, determined on 1.0 g [2, 5, 6]. 

Indian Pharmacopoeia determines the copper content using a color intensity method, according to the following procedure. Moisten 1 g of... 

According to the Indian Pharmacopoeia, 2,3-dimethylaniline is examined by TLC using a silica gel G plate, and a mixture of 90 volumes of toluene, 25 volumes of dioxane, and 1 volume of 18 M ammonia as the mobile phase. Apply 40 pL of each of the two solutions in a mixture of 3 volumes of chloroform and 1 volume of methanol containing (1) 2.5% w/v of the substance being examined separately to the plate, and (2) 0.00025% w/v of 2,3-dimethylaniline. After removal of the plate, dry it in a current of warm air. Spray the dried plate with ethanolic sulfuric acid (20%), heat at... 

According to the British Pharmacopoeia 2002, the European and Indian Pharmacopoeias, and the Pharmacopoeia of the People s Republic of China, the assay for mefenamic acid is performed by a titration method. About 0.200 g of the substance to be assayed is dissolved with the aid of ultrasound in 100 mL of warm ethanol that has been previously neutralized to the phenol red endpoint. About 0.1 mL of phenol red solution is added and titrated with 0.1 M sodium hydroxide. Each milliliter of 0.1 M NaOH is equivalent to 24.13 mg of mefenamic acid [2, 5-7],... 

Regulatory Status. Undetermined in the United States official in the French pharmacopoeia as early as 1884 official in Indian pharmacopoeia also once official in the Dutch, Mexican, Spanish, and Venezuelan pharmacopoeias. 

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