AMENDMENTS TO I.P.

2010
Monographs Upgraded. Page xxi
Column 3, line 23
Change from: Ketonazole to: Ketoconazole

Column 3, line 24
Change from: Ketonazole Tablets to: Ketoconazole Tablets

2.4.26 Solubility
Anastrozole. Page 149
Change from: Soluble in water. to: Very soluble in acetonitrile; freely soluble in methanol, in acetone, in ethanol,
and in tetrahydrofuran.

Escitalopram Oxalate. Page 156

Line 2
Delete “soluble in isotonic solution”

Etodolac. Page 156

Change from: in aqueous polyethylene and in glycol to: in polyethylene glycol.

Fenofibrate. Page 157

Change from: Soluble in ethanol (95 per cent), in dimethylsulphoxide, in dimethylformamide; sparingly soluble in
aqueous buffers. to: Very soluble in dichloromethane, slightly soluble in ethanol (95 per cent); practically insoluble
in water.

Formoterol Fumarate Dihydrate. Page 157, line 2

Change from: ethanol to: methanol

Irinotecan Hydrochloride Trihydrate. Page 159,

Change from: Soluble in water. to: Freely soluble in glacial acetic acid; slightly soluble in water and ethanol.

Simvastatin. Page 167

Change from: Practically insoluble in ethanol (95 per cent). to: Practically insoluble in water.

Sucralose. Page 168

Change from: Soluble in water. to: Freely soluble in water, in methanol, and in ethanol (95 per cent); slightly
soluble in ethyl acetate.

4.5. VOLUMETRIC REAGENTS AND SOLUTIONS. Page 635

Sulphuric acid, 0.5 M, Line 1
Change from: 30 ml to: 28 ml
MONOGRAPHS
Amlodipine Besylate. Page 806
Add synonym: Amlodipine Besilate

Amlodipine Tablets. Page 807

Add synonym: Amlodipine Besylate Tablets

S-Amlodipine Besylate. Page 808

Add synonym: S-Amlodipine Besilate

S-Amlodipine Tablets. Page 809

Add synonym: S-Amlodipine Besilate Tablets

Amoxycillin and Potassium Clavulanate Oral Suspension. Page 818

Usual stength.
Change to: Amoxycillin 200 mg and Clavulanic acid 28.5 mg per 5 ml

Amoxycillin and Potassium Clavulanate Tablets. Page.819

Usual stength.
Change from: 125 mg; 500 mg to: Amoxycillin 500 mg and Clavulanic acid 125 mg

Beclomethasone Inhalation. Page 874

Related substances. Test solution. Line 2
Change from: 50 mg to: 0.5 mg

Benzalkonium Chloride. Page 877

Para 2, lines 3 and 4
Change from: dried basis to: anhydrous basis

Benzyl Alcohol. Page 891

Related substances. Chromatographic system, line 1
Change from: glass column to: capillary column

Loss on drying
Change from: Loss on drying (2.4.19). Not more than 0.05 per cent.
to: Residue on evaporation. Not more than 0.05 per cent.
After ensuring that the substance under examination complies with the test for peroxide value, evaporate 10.0 g of
Benzyl Alcohol, on a water-bath to dryness, and dry the residue at 105° for 1 hour. Cool in a desiccator and weigh.

Cefpodoxime Oral Suspension. Page 1019

Usual strengths.
Change from: 30 ml to: 50 mg per 5 ml; 100 mg per 5 ml

Cetostearyl Alcohol. Page 1040

Insert the following before Category
“Cetostearyl Alcohol contains not less than 40.0 per cent of stearyl alcohol and sum of stearyl alcohol and cetyl
alcohol is not less than 90.0 per cent.”

Assay. Chromatographic system, line 1

Change from: glass column to: capillary column
Cetyl Alcohol. Page 1042
Insert the following before Category
Cetyl Alcohol contains not less than 95.0 per cent of C16H34O.

Assay. Chromatographic system, line 1

Change from: glass column to: capillary column

Chlorthalidone Tablets. Page 1077

Related substances. Insert the following before Test solution
“Mobile phase. A mixture of 75 volumes of butanol and 15 volumes of 1M ammonia.”

Citalopram Tablets. Page 1098

Assay. Chromatographic system, line 5
Change from: dodecyltrimethylammonium bromide, to: dodecyltrimethylammonium bromide in the solvent mixture,

Citric Acid. Page 1099

Identification. A.
Change to: Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained
with citric acid RS.

Citric Acid Monohydrate. Page 1100

Identification. A.
Change to: Determine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained
with citric acid RS.

Divalproex Sustained-release Tablets. Page 1241

Title
Change from: Divalproex Sustained-release Tablets
to: Divalproex Tablets

Lines 1and 2
Change from: Divalproex Sodium Sustained-release Tablets; Sodium Valproate Sustained-release Tablets
to: Divalproex Sodium Tablets

Para 2
Change to: Divalproex Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the stated
amount of valproic acid, C8H16O2. The tablets are enteric coated.
Uniformity of content. Delete the requirement

Escitalopram Oxalate. Page 1293

Assay. Test solution, lines 3 and 4
Delete “Further dilute 1.0 ml of this solution to 10.0 ml with the mobile phase.

Flutamide. Page 1380

Assay. Line 6
Change from: Calculate the content of C11H11F3N2O3 taking the specific absorbance at about 295 nm. to: Calculate
the content of C11H11F3N2O3 taking 295 as the specific absorbance at 295 nm.

Ibuprofen Tablets. Page 1482, line 6

Dissolution Last line
Add the following after 221 nm (2.4.7).
“Similarly, measure the absorbance of the solution of known concentration of ibuprofen RS.”
Ketoconazole Tablets. Page 1541
Dissolution. Line 1
Change from: Apparatus No. 2, to: Apparatus No. 1,

Lamotrigine Dispersible Tablets. Page 1567

Dissolution. Chromatographic system, line 2
Change from: ilica to: silica

Losartan Potassium and Hydrochlorothiazide Tablets. Page 1610

Dissolution. After chromatographic system, line 6
Change from: C22H22ClK6O to: C22H22ClKN6O

Mercaptopurine Tablets. Page 1654

Dissolution. After chromatographic system, line 6 and last line
Change from: C5H4N4S to: C5H4N4S,H2O

Mometasone Furoate. Page 1700

Related substances. Last para, line 6
Change from: solution (a) to: solution (b)

Loss on drying. Line 1

Change from: 5.0 per cent to: 0.5 per cent

Pantoprazole Sustained-release Tablets. Page 1857

Title
Change from: Pantoprazole Sustained-release Tablets
to: Pantoprazole Tablets

Line 1
Change from: Pantoprazole Sodium Sustained-release Tablets
to: Pantoprazole Sodium Tablets

Para 1
Change to: Pantoprazole Tablets contain not less than 90.0 per cent and not more than 110.0 per cent of the stated
amount of pantoprazole, C16H15F2N3O4S. The tablets are enteric coated.

Poloxamers. Page 1928

Average relative molecular mass. Add the following at the end

Oxypropylene:oxyethylene ratio. Add the following at the end

Sodium Valproate. Page 2139

Line 1
Delete: “ Divalproex Sodium”
Stearyl Alcohol. Page 2155
Insert the following before Category
Stearyl Alcohol contains not less than 95.0 per cent of C18H38O.

Sucralose. Page 2165

Insert the following before Identification
“Description. A white to off-white crystalline powder.