Comments on Draft Amendments

The Indian Pharmacopoeia Commission has received suggestions from stakeholders on standards to be complied with drugs included in the Indian Pharmacopoeia for time being in force and such other standards as prescribed from time to time by the Commission.

In order to adhere on the principle of “openness, justice and fairness” the feedback and inputs received from various users have been reviewed by the relevant Expert Subject Committee to ensure the feasibility and practibility of the standards and methods.

The draft amendments are reproduce below for comments. The comments may be forwarded to the IPC Secretariat upto June 2009. For details log on to www.ipc.gov.in

Amendments Proposed in IP 2007

Introduction. xxi
Ommissions Before Pectin
Insert “ Self emulsifying Glyceryl Monostearate”

1. General Notices. Page 13
Quantities. Para 3, line 6
For ‘0r’ read ‘or’

Reagents and Solutions. Para 1, line 6
For ‘regents’ read ‘reagents’

2.1.7. Weights and Balances. Page 2331
For ‘50 µg’ read ‘0.05 mg’

Add the following at the end
‘Class 1.1 weights are used for calibration of low-capacity, high sensitivity balances. They are available in various denominations from 1 to 400 mg. The tolerance for any denomination in this class is 5 µg. They are recommended for calibration of balances for using optical or electrical methods for accurately weighing quantities below 20 mg.

Class 1 weights are designated at high-precision standards for calibration. They may be used for weighing accurately quantities below 20 mg.

Class 2 weights are used at working standards for calibration, built-in weights for analytical balances, and laboratory weights for routine analytical work.

Class 2 and class 4 weights are used with moderate-precision laboratory balances’.

2.3.28. Iodine Value. Page 82
Method B. Table
For ‘21 to 60’ read ‘20 to 60’

2.3.41. Assay of Vitamin A. Page 90
Method A. Procedure, before table 1
For ‘?’ read ‘x’

Method B. Procedure, page 92, line 2
For ‘?’ read ‘x

2.3.45. Ethanol. Page 95
For ‘Method I

Determine by gas chromatography (2.4.13).
Test solution. A 5.0 per cent v/v of ethanol and 5.0 per cent v/v of 1-propanol (internal standard).
Reference solution (a). Dilute a volume of the preparation under examination with water to contain between 4.0 and 6.0 per cent v/v of ethanol.
Reference solution (b). Prepare in the same manner as reference solution (a) but adding sufficient of the internal standard to produce a final concentration of 5.0 per cent v/v.
Chromatographic system
– a glass column 1.5 m ´ 4 mm, packed with porous
polymer beads (100 to 120 mesh),
– temperature:
column.150º,
inlet port and detector. 170º,
– nitrogen as carrier gas.
Calculate the percentage content of ethanol from the areas of the peaks due to ethanol in the chromatogram obtained with test solutions and reference solution (b).

Method II
For preparations where the use of Industrial Methylated Spirit is permitted in the monograph, determine the content of ethanol as described in Method I but using as following solution
Reference solution (a). A volume of the preparation under examination diluted with water to contain between 4.0 and 6.0 per cent v/v of total ethanol and methanol.
Determine the concentration of methanol in the following manner. Using the chromatographic condition as described under Method I but using the following solutions.
Test solution. A 0.25 per cent v/v of methanol and 0.25 per cent v/v of 1-propanol (internal standard).
Reference solution (a). Dilute a volume of the preparation under examination with water to contain between 0.2 per cent and 0.3 per cent v/v of methanol.
Reference solution (b). Prepare in the same manner as reference solution (a) but adding sufficient of the internal standard to produce a final concentration of 0.25 per cent v/v.
The sum of the contents of ethanol and methanol is within the range specified in the individual monograph and the ratio of the content of methanol to that of ethanol is commensurate with Industrial Methylated Spirit having been used’.

read ‘Determine by gas chromatography (2.4.13).
Test solution (a). Dilute a volume of the preparation under examination with water to contain between 4.0 and 6.0 per cent v/v of ethanol.
Test solution (b). Prepare in the same manner as test solution (a) but adding sufficient of the internal standard to produce a final concentration of 5.0 per cent v/v.
Reference solution. A 5.0 per cent v/v of ethanol and 5.0 per cent v/v of 1-propanol (internal standard).
Chromatographic system
– a glass column 1.5 m ´ 4 mm, packed with porous polymer beads (100 to 120 mesh),
– temperature:
column.150º,
inlet port and detector. 170º,
– nitrogen as carrier gas.
Calculate the percentage content of ethanol from the areas of the peaks due to ethanol in the chromatogram obtained with test solution (b) and reference solution.

Method II
For preparations where the use of Industrial Methylated Spirit is permitted in the monograph, determine the content of ethanol as described in Method I but using as following solution
Test solution (a). A volume of the preparation under examination diluted with water to contain between 4.0 and 6.0 per cent v/v of total ethanol and methanol.
Determine the concentration of methanol in the following manner. Using the chromatographic condition as described under Method I but using the following solutions.
Test solution (a). Dilute a volume of the preparation under examination with water to contain between 0.2 per cent and 0.3 per cent v/v of methanol.
Test solution(b). Prepare in the same manner as test solution (a) but adding sufficient of the internal standard to produce a final concentration of 0.25 per cent v/v.
Reference solution. A 0.25 per cent v/v of methanol and 0.25 per cent v/v of 1-propanol (internal standard).
The sum of the contents of ethanol and methanol is within the range specified in the individual monograph and the ratio of the content of methanol to that of ethanol is commensurate with Industrial Methylated Spirit having been used’.

2.4.14. Liquid Chromatography. Page 128
Secondary peak
Insert the following after para 1
Solvent or derivatising agents peaks identified as due to the counter-ion and/ or other excipients including preservatives in the substance under examination may also be excluded.

2.4.19. Loss on drying. Page 134
Add the following after para 1
Where the drying temperature is indicated by a single value other than a range, drying is carried out at the prescribed temperature ± 2°.

2.4.26. Solubility
Insert before Arteether. Page 144
Alpha Amylase. Sparingly soluble in water (except when admixed with an insoluble diluents ); insoluble in ethanol (95 per cent) and in ether.

Cefixime. Page 2335
Change the statement to:
Cefixime. Soluble in methanol; sparingly soluble in ethanol (95 per cent); practically insoluble in ethyl acetate and in water.

Citalopram Hydrobromide. Page 2335
Change the statement to:
Citalopram Hydrobromide. Freely soluble in methanol; practically insoluble in ether.

Clopidogrel Bisulphate. Page 2335
Change the statement to:
Clopidogrel Bisulphate. Freely soluble in methanol; practically insoluble in ether.

Isosorbide Mononitrate, Diluted. Page 2336
Change the statement to:
Diluted Isosorbide Mononitrate. Undiluted isosorbide mononitrate is freely soluble in water, in acetone, in absolute ethanol and in dichloromethane.

Losartan Potassium. Page 153
For ‘soluble in isopropyl alcohol’ read ‘sparingly soluble in isopropyl alcohol’

Mosapride Citrate Dihydrate. Page 2336
Change the statement to:
Mosapride Citrate Dihydrate. Soluble in dimethylformamide; sparingly soluble in methanol; practically insoluble in water.

Oxcarbazepine. Page 2336
Change the statement to:
Oxcarbazepine. Soluble in acetic acid; slightly soluble in chloroform and in methanol; practically insoluble in water.

Pioglitazone Hydrochloride. Page 2336
Change the statement to:
Pioglitazone Hydrochloride. Soluble in dimethylformamide; very slightly soluble in acetronitrile; practically insoluble in water and in ether.

Quetiapine Fumarate. Page 2336
Line 2
For ‘slightly’ read ’sparingly’

Tinidazole. Page 162
For ‘Tinidazole. Sparingly soluble in water; slightly soluble in ethanol (95 per cent), in chloroform and in ether’. read ‘Tinidazole. Soluble in acetone and in dichloromethane; sparingly soluble in methanol; slightly soluble in ethanol (95 per cent), and in chloroform; practically insoluble in water’.

2.4.28. Viscosity. Page 165
Add the following after Method C
A convenient type of instrument is a rotational utilizing a spindle immersed in the test preparation and measures the resistance to movement of the rotating part. Several spindles and rotational speeds are generally available for given viscosity ranges. Since small temperature changes may lead to marked changes in viscosity, the temperature should be held to within ± 0.1°.

Add the following (NEW APPENDIX). At Page 188

2.5.10. Validation of Analytical Procedures

Validation of analytical procedure is performed to show is suitable for its intended purpose and the results generated are reliable and accurate.

Text and methodology are published as guidance. 02 (R1) by International Conference on Harmonisation (ICH).

4.5. Volumetric Reagents and Solutions

Perchloric acid, 0.1 M. Page 550
Para 1, lines 7, 10 and 12

For ‘0.05 per cent’ read ‘0.5 per cent’

Acarbose. Page 678
Related substances. Last para, lines 6 to 8
For ‘twice the area of the peak in the chromatogram obtained with the reference solution (b) (2.0 per cent)’. read ‘thrice the area of the peak in the chromatogram obtained with reference solution (b) (3.0 per cent)’.

Acebutolol Hydrochloride. Page 2355
Assay. Insert the following after line 6
‘0.03729 g of’
Adrenaline Injection. Page 691
Assay. Change the test to:
Assay. Determine by liquid chromatography (2.4.14).
Test solution. Accurately measured volume of the injection containing 20 mg of Adrenaline Tartrate diluted to 100.0 ml with the mobile phase.
Reference solution (a). A 0.02 per cent w/v solution of adrenaline acid tartrate RS in the mobile phase.
Reference solution (b). A solution containing 0.02 per cent w/v of adrenaline acid tartrate RS and 0.02 per cent w/v of noradrenaline acid tartrate in the mobile phase
Chromatographic system
– a stainless steel column 10 cm × 4.6 mm packed with octadecylsilane bonded to porous silica (5 µm) (Such as Nucleosil C18),
– mobile phase: a solution prepared by adding 4.0 g of tetramethylammonium hydrogen sulphate, 1.1 g of sodium heptanesulphonate and 2 ml of 0.1 M disodium edetate to a mixture of 950 volumes of water and 50 volumes of methanol and adjusting the pH of the mixture to 3.5 with 1 M sodium hydroxide,
– flow rate. 2 ml per minute,
– spectrophotometer set at 205 nm,
– a 20 µl loop injector.
Inject reference solution (b). The test is not valid unless the resolution between the peaks due to adrenaline acid tartrate and noradrenaline acid tartrate in the chromatogram obtained is not less than 2.0.

Inject the test solution and reference solution (a).
Calculate the content of C9H13NO3 in the injection.

Albendazole Tablets. Page 693
Insert at the end

Labelling: The label states that the tablets should be chewed before swallowing.
Benzyl Alcohol. Page 789 Lline 1
For ‘Benzyl AIcohol’ read ‘Benzyl Alcohol’

Butylated Hydroxytoluene. Page 825
Insert the following before Appearance of solution
Freezing point (2.4.11). 69° to 70°.

Calcitriol. Page 2369
Assay. Last para, line 1

For ‘reference solution (b)’ read ‘reference solution (a)’

Carvedilol Tablets. Page 2373
Related substances. Line 6

For ‘(0.2 per cent)’ read ‘(0.5 per cent)’

Cefixime. Page 2377
Assay. Change the test to:

Assay. Determine by liquid chromatography (2.4.14).
Phosphate buffer pH 7.0. Dissolve 7.1 g dibasic sodium phosphate in water and dilute to 500 ml with water. Adjust the pH of the solution to 7.0 with monobasic potassium phosphate solution.
Monobasic potassium phosphate solution. Dissolve 6.8 g of monobasic potassium phosphate in water and dilute to 500 ml with water.
Test solution. Weigh accurately about 25 mg of the substance under examination and dissolve in sufficient phosphate buffer pH 7.0 to produce 25.0 ml.
Reference solution (a). Dissolve 25 mg of cefixime RS in sufficient phosphate buffer pH 7.0 to produce 25.0 ml.
Reference solution (b). Dilute 1.0 ml of reference solution (a) to 100.0 ml with phosphate buffer pH 7.0.
Reference solution (c). Dissolve 10 mg of cefixime RS in 10 ml of water. Heat on a water-bath for 45 minutes. Cool and inject immediately.
Chromatographic system
– a stainless steel column 12.5 cm × 4 mm, packed with octadecylsilane chemically bonded to porous silica (5 µm),
– column temperature 40°,
– mobile phase: a mixture of 25 volumes of acetonitrile and 75 volumes of a tetrabutylammonium hydroxide solution prepared by diluting 25 ml of 0.4 M tetrabutylammonium hydroxide solution to 1000 ml with water and adjusting the pH to 6.5 with 1.5 M orthophosphoric acid,
– flow rate. 1 ml per minute,
– spectrophotometer set at 254 nm,
– a 10 µl loop injector.
Inject reference solution (c). The relative retention times are about 0.9 for cefixime E-isomer and 1.0 for cefixime and the resolution between cefixime and cefixime E-isomer is not less than 2.0.
Inject reference solution (a). The column efficiency is not less than 4000 theoretical plates, the tailing factor is not less than 0.9 and not more than 2.0.
Inject the test solution and reference solution (a).
Calculate the content of C16H15N5O7S2.

Citric Acid. Page 942
Description. Line 2
For ‘moist dry air’ read ‘moist air’

Chlorides. Lines 2 and 3
Delete the following.
The resulting solution complies with the limit test for chlorides
Clopidogrel Bisulphate. Page 2390
Related substances. Change the test to:
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 100 mg of the substance under examination in 5.0 ml of methanol and dilute to 200.0 ml with the mobile phase.
Reference solution. A solution containing 20 µg per ml of clopidogrel bisulphate RS, 40 µg per ml of [(+)-(S)-(o-chlorophenyl )-6,7-dihydrothieno(3-2-c]pyridine-5(4H)-acetic acid] RS (clopidogrel impurity A RS), 120 µg per ml of [methyl(±)-(o)-chlorophenyl)-4,5 dihydrothieno(2,3-c)pyridine-6(7H)-acetate, hydrogen sulphate] RS (clopidogrel impurity B RS), and 200 µg per ml of [methyl(-)-(R)-o-chlorophenyl)-6,7 dihydrothieno(3,2-c)pyridine-5(4H)-acetate,hydrogen sulphate]RS (clopidogrel impurity C RS), in methanol. Dilute 5.0 ml of the solution to 200.0 ml with the mobile phase.
Chromatographic system
– a stainless steel column 15 cm x 4.6 mm, packed with chiral recognition protein, ovomucoid, chemically bonded to porous silica (5 µm),
– mobile phase: a mixture of 75 volumes of a buffer solution prepared by dissolving 1.36 g of potassium phosphate in 1000 ml of water and 25 volumes of acetonitrile,
– flow rate. 1 ml per minute,
– spectrophotometer set at 220 nm,
– a 10 µl loop injector.
Inject the reference solution. The relative retention time with respect to clopidogrel, for impurity A is about 0.5, for enantiomers of clopidogrel impurity B, about 0.8 and 1.2 and for clopidogrel impurity C, about 2.0. The test is not valid unless the resolution between clopidogrel and the first enantiomer of clopidogrel impurity B is not less than 2.5.
Inject the test solution and the reference solution. In the chromatogram obtained with the test solution the area of the peak due to clopidogrel impurity A is not more than the area of the corresponding peak in the chromatogram obtained with the reference solution ( 0.2 per cent ), the area of the peak due to the first enantiomer of clopidogrel impurity B is not more than the area of the corresponding peak in the chromatogram obtained with the reference solution ( 0.3 per cent ) and the area of the peak due to clopidogrel impurity C is not more than the area of the corresponding peak in the chromatogram obtained with the reference solution ( 1.0 per cent ). The area of any peak due to other impurities is not more than the area of the peak due to clopidogrel bisulphate RS in the chromatogram obtained with the reference solution (0.1 per cent). The sum of all the impurities is not more than 1.5 per cent.
Assay. Chromatographic system, line 5

For ‘potassium phosphate’ read ‘monobasic potassium phosphate’

Clopidogrel Tablets. Page 2391
Related substances. Last para, lines 8-12
For ‘The area of any peak due to other impurities is not more than the area of the peak due to clopidogrel bisulphate RS in the chromatogram obtained with reference solution (a) (0.1 per cent). The sum of all the impurities is not more than 2.5 per cent’. read ‘The area of any peak due to other impurities is not more than twice the area of the peak due to clopidogrel bisulphate RS in the chromatogram obtained with reference solution (a) (0.2 per cent, excluding impurity B). The sum of all the impurities is not more than 2.5 per cent, excluding impurity B’.

Assay. Chromatographic system, line 5

For ‘potassium phosphate’ read ‘monobasic potassium phosphate’

Clotrimazole Cream. Page 958
Assay. Chromatographic system, line 1
For ‘25 cm’ read ‘20 cm’

Clozapine Tablets. Page 2393
Identification. B., lines 3 and 4
For ‘reference solution’ read ‘reference solution (a)’

Cytarabine. Page 986
Related substances. Change the test to:
Related substances. Determine by thin-layer chromatography (2.4.17), coating the plate with silica gel GF254.
Mobile phase. A mixture of 65 volumes of 2-butanone, 20 volumes of acetone and 15 volumes of water.
Test solution (a). A 5 per cent w/v solution of the substance under examination in water.
Test solution (b). A 0.2 per cent w/v solution of the substance under examination in water.
Reference solution (a). A 0.025 per cent w/v solution of the substance under examination in water.
Reference solution (b). A solution containing 0.2 per cent w/v solution of cytarabine RS in water.
Apply to the plate 5 µl of each solution. After development, dry the plate in air and examine in ultraviolet light at 254 nm. Any secondary spot in the chromatogram obtained with test solution (a) is not more intense than the spot in the chromatogram obtained with reference solution (a) (0.5 per cent).

Dexamethasone Sodium Phosphate. Page 1006
Delete the test “Free dexamethasone”

Ethanol. Line 1
For ‘Not more than 3.0 per cent’ read ‘Not more than 8.0 per cent’
Water (2.3.43). Delete the test

Total ethanol and water. Line 1
For ‘Total ethanol and water. Not more than 16.0 per cent w/w,’ read ‘Total ethanol and water. Determine the content of water (2.3.43), using 0.2 g. Not more than 16.0 per cent w/w,’

Dexamethasone Injection. Page 1007
pH. Line 1
For ‘7.5 to 8.5’ read ‘7.0 to 8.5’

Disodium Edetate. Page 1047
Change structural formula to :

Dibasic Calcium Phosphate. Page 846
Assay. Add the following after line 7

Carry out a blank titration.

Esomeprazole Tablets. Page 2398
Opening statement. Para 1. line 3.
Insert ‘The tablets are enteric coated.’

Dissolution. Change the test to :
Dissolution (2.5.2).
A. Apparatus No. 1
Medium. 900 ml of 0.1 M hydrochloric acid.
Speed and time. 75 rpm and 120 minutes.
At the end of 120 minutes, drain the acid solution slowly without losing any tablet fragments. Transfer the entire contents to a 100-ml volumetric flask (in the case of 20 mg tablets) or a 200-ml volumetric flask (in the case of 40 mg tablets), add about 80 ml of methanol (in the case of 20 mg tablets) or 160 ml (in the case of 40 mg tablets), and disperse the tablets with the aid of ultrasound for 15 minutes. Dilute to volume with methanol. Mix well with the aid of ultrasound to disperse the tablets further for 5 minutes and centrifuge at 4000 rpm for 10 minutes. Dilute 5.0 ml of the supernatant liquid to 25.0 ml with the mobile phase.
Using the resulting solution as the test solution, immediately carry out the determination as described in the Assay. Calculate the content of C34H36N6O6S2 in the supernatant liquid.
Not more than 10 per cent of the stated amount of C34H36N6O6S2.
B. Apparatus No. 1
Medium. 900 ml of 0.2 M mixed phosphate buffer pH 6.8,
Speed and time. 75 rpm and 60 minutes.
Transfer the tablets used in test A and run the apparatus for 60 minutes. Decant the solution and centrifuge. Using the supernatant liquid as the test solution, immediately carry out the determination of C34H36N6O6S2 in the medium.
D. Not less than 70 per cent of the stated amount of C34H36N6O6S2.

Ethambutol Hydrochloride. Page 1097
Meso ethambutol (RS isomer). Method B.
Add the following before Test solution

Note- Use freshly prepared solution.

Chromatographic system, line 6
For ‘B. water,’ read ‘B. methanol,’

Fluocinolone Acetonide. Page 1128
Identification. B., Reference solution (a), line 1
For ‘fludrocortisones RS’ read ‘fluocinolone acetonide RS’

Fusidic acid. Page 2409
Related substances. Reference solution (b), line 2
For ‘20 µl’ read ‘2.0 µl’

2-Deoxy-D-Glucose. Page 1168
Assay. Chromatographic system, lines 1-3
For ‘a stainless steel column 25 cm × 4.6 mm, packed with rigid spherical etyrene- divinyl benzenecopolymer (5 to 10 µm),’ read ‘a stainless steel column 25 cm × 4.6 mm, packed with octylsilane bonded to porous silica (5 µm),’

Hydroxypropylmethylcellulose. Page 1208
Heavy metals. Line 1
For ‘(2.3.12)’ read ‘(2.3.13)’

Diluted Isosorbide Mononitrate. Page 2413
Description. Line 1
For ‘A white, crystalline powder’ read ‘Undiluted isosorbide mononitrate is a white, crystalline powder’.

Isoxsuprine Hydrochloride. Page 1256
Assay. Lines 3 and 4
For ‘Cool and titrate with 0.1 M perchloric acid, using naphtholbenzein as indicator.’ read ‘Cool and add 15 ml of mercuric acetate solution. Titrate with 0.1 M perchloric acid, using naphtholbenzein as indicator.’

Levocetirizine Tablets. Page 1291
Opening statement. Line 3
For ‘C21H27Cl3N2O3,2HCl’ read ‘C21H25ClN2O3,2HCl’

Dissolution. Line 11
For ‘C21H27Cl3N2O3,2HCl’ read ‘C21H25ClN2O3,2HCl’

Assay. Last line
For ‘C21H27Cl3N2O3,2HCl’ read ‘C21H25ClN2O3,2HCl’

Magnesium Trisilicate. Page 1336
Chlorides. Line 1
For ‘0.5 ml’ read ‘5.0 ml’
Meropenem Injection. Page 1357
Loss on drying. Line 2
For ‘vaccume’ read ‘vacuum’

Labelling. Line 1
For ‘sodium (Na)’ read ‘meropenem’
Methylergometrine Tablets. Page 1372
Uniformity of content. Line 21
For ‘545 nm’ read ‘550 nm’

Nebivolol Hydrochloride. Page 2424
Related substances. Last para, lines 1to 3
Delete the following
Run the chromatograms for eight times the retention time of the principal peak.

Nebivolol Tablets. Page 2425
Assay. Test solution.
For ‘Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 50 mg of nebivolol, disperse in 100.0 ml of the mobile phase and filter. Dilute 10.0 ml of this solution to 100.0 ml with the mobile phase’. read ‘Weigh and powder 20 tablets. Weigh accurately a quantity of the powder containing about 5 mg of nebivolol, disperse in 100.0 ml of the mobile phase and filter’.

Nifedipine Sustained-release Tablets. Page 1444
Dissolution. A. Line 10
For ‘in the same medium’. read ‘prepared by dissolving in minimum volume of methanol and then diluting with the dissolution medium’.

B. Line 10
For ‘in the same medium’. read ‘prepared by dissolving in minimum volume of methanol and then diluting with the dissolution medium’.

Olanzapine. Page 1471
Related substances. Last para., lines 1 and 2
Delete the following
Run the chromatogram for three times.

Oxcarbazepine. Page 2432
Related substances. After chromatographic system, para 1, line 2
For ‘in’ read ‘is’

Oxcarbazepine Tablets. Page 2433
Related substances. After chromatographic system, para 1, line 2
For ‘in’ read ‘is’

Piracetam. Page 2436
Related substances. Test solution (a)., line 2
For ‘10.0 ml’ read ‘100.0 ml’

After chromatographic system, para 2, line 3
For ‘test solution’ read ‘test solution (a)’

Assay. Para 2, line 1
For ‘reference solution (a)’ read ‘reference solution (c)’

Prednisolone. Page 1583
Related substances. Last para, line 6
For ‘half the area’ read ‘the area’

Quetiapine Fumarate. Page 2440
Related substances. Last para, line 1
For ‘reference solutions (b) and (c)’ read ‘reference solutions (a) and (b)’

Quinine Dihydrochloride Injection. Page 1637
Identification. Para 3 and 4
For ‘Test solution. Extract a volume of the injection containing
0.1 g of Quinine Dihydrochloride Bisulphate with 10 ml of a mixture of 2 volumes of chloroform and 1 volume of ethanol (95 per cent) and filter.
Reference solution (a). A 1 per cent w/v solution of quinine sulphate in the same solvent mixture.
Reference solution (b). A solution of 1 per cent w/v of each of quinidine sulphate RS and quinine sulphate RS in the same solvent mixture’.

read ‘ Solvent mixture. 2 volumes of chloroform and 1 volume of ethanol (95 per cent).
Test solution. Extract a volume of the injection containing
0.1 g of Quinine Dihydrochloride Bisulphate with 10 ml of the solvent mixture and filter.
Reference solution (a). A 1 per cent w/v solution of quinine sulphate RS in the solvent mixture.
Reference solution (b). A solution of 1 per cent w/v of each of quinidine sulphate RS and quinine sulphate RS in the solvent mixture’.

Identification C.
For ‘Solution A gives’ to: ‘It gives’

Rabeprazole Tablets. Page 2441
Dissolution. Lines 8 – 14
For ‘with a buffer solution prepared by dissolving 7.16 g of disodium hydrogen phosphate in 1000 ml of water and adjusting the pH to 10.4 with 2 M sodium hydroxide, if necessary, at the maximum at about 291 nm (2.4.7). Calculate the content of C18H20N3O3SNa in the medium from the absorbance obtained from a solution of known concentration of rabeprazole sodium RS, prepared in the same manner’. read ‘with the dissolution medium, if necessary, at the maximum at about 291 nm (2.4.7). Calculate the content of C18H20N3O3SNa in the medium from the absorbance obtained from a solution of known concentration of rabeprazole sodium RS, prepared by dissolving in minimum quantity of a mixture of 75 volumes of acetonitrile and 25 volumes of methanol and suitably diluted with the dissolution medium’.

Assay. Chromatographic system. Lines 5 and 6
For ‘orthophosphoric acid’ read ‘sodium hydroxide solution’

Ritonavir Tablets. Page 1673
Dissolution. Line 2
For ‘900 ml of 0.1 M hydrochloric acid’ read ‘900 ml of a solution prepared by dissolving 15.7 g of polyoxyethylene 10-lauryl ether in 1000 ml of a 0.85 per cent v/v solution of hydrochloric acid’.

Rosiglitazone Tablets. Page 1676
Other tests.
For ‘Capsules’ read ‘Tablets’

Tenofovir and Emtricitabine Tablets. Page 1785
Assay. Chromatographic system. Line 2
For ‘octadecylsilane’ read ‘octylsilane’

Topiramate Tablets. Page 2452
Related substances. Chromatographic system, line 8
For ‘refractive index detector’ read ‘refractive index detector (Detector cell temperature 50°)’.

Tribasic Calcium Phosphate. Page 846
Assay. Add the following after line 7
Carry out a blank titration.

Imipenem and Cilastastin Injection. Page 2292
Column 1. Last line
For ‘Imipenem and Cliastastin Injection’ read ‘Imipenem and Cilastastin Injection’

VETERINARY PRODUCTS

Ivermectin Injection. Page 2177
Assay. Test solution, line 2
For ‘water’ read ‘methanol’

Reference solution, line 2
For ‘water’ read ‘methanol’