INDIAN PHARMACOPOEIA COMMISSION AMENDMENT LIST-03 TO IP 2022

General Notices Ciclesonide. Line 2

Production. Page 13, 1287, 3001, 4795 Change from : methanol

to : ethanol
Last para, line 6
Page 289
Change from : Drugs and Cosmetics Rules, 1945
Prasugrel Hydrochloride.
to : Drugs Rules, 1945
Storage. Page 16, 1290, 3004, 4798 Change to: Freely soluble in methanol; slightly soluble in
water and acetonitrile and practically insoluble in heptane.
Last para, line 2
Change from : D&C rules 1945
to : Drugs Rules, 1945 5.6. Water for Pharmaceutical Use. Page 1183
Labelling. Page 17, 1291, 3005, 4799 Drinking Water. Para 2, line 7 and 8
Line 2 Change from : Drugs & Cosmetics Rules, 1945.
Change from : Drugs and Cosmetics Rules, 1945 to : Drugs Rules, 1945
to : Drugs Rules, 1945

6.2. CONTAINERS. Page 1228

2.4.1. Appearance of Solution. Page 211
6.2.1. Plastic Containers. Table 1, Column 3, para 3
Clarity of Solution
Change from : The Drugs and Cosmetics Rules, 1945
Method. Line 4 and 5
to : Drugs Rules, 1945
Change from : Into another matched test-tube add the same
volume of the freshly prepared opalescence standard.
to : Into another matched test-tube add the same 6.4. Labels on Container. Page 1267
volume of water or the solvent used for preparing the solution
being examined or the freshly prepared opalescence standard. 6.4.1. Basic Statutes Governing Labelling. Line 4
Change from : Drugs & Cosmetics Rules, 1945.
to : Drugs Rules, 1945
2.4.24. pH Values. Page 260
Insert before Method
NOTE — Commercially available buffer solutions
for pH measurement system, calibrated by methods traceable Pessaries. Page 1341
to NIST/ concerned regulatory authority, labeled with
Suppositories. Para 3, line 3 and 4
a pH value accurate to 0.02 pH units may be used. Buffer
solutions that are equal to or more than 12 should be used Change from : Drugs and Cosmetics Rules, 1945.
immediately or should be prepared using freshly boiled water, to : Drugs Rules, 1945.
and stored under conditions to minimize carbon dioxide
absorption and ingress.

2.4.26. Solubility Amlodipine and Atenolol Tablets. Page

1448
Page 271
Related substances. For Amlodipine — Line 2 and 3
Chlorhexidine Gluconate Solution.
Change from : amlodipine impurity D
Change to: Miscible with glacial acetic acid and with water;
miscible with three times its volume of acetone and with five to : amlodipine impurity D (3-ethyl 5-methyl
times its volume of ethanol; further addition of acetone or 2-[(2-aminoethoxy) methyl]- 4-(2-chlorophenyl)-6-
ethanol gives a white turbidity. methylpyridine-3,5-dicarboxylate)

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AMENDMENT LIST-03 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Arterolane Maleate. Page 1508 to the arginine peak in the chromatogram obtained with the
reference solution or gives the reactions of sodium salts and
Related substances. Inset at the end reaction A of carbonates (2.3.1).
Ignore the peak due to maleic acid and peak with an area less Sodium carbonate. Change to:
than 0.1 times the area of the principal peak in the
chromatogram obtained with the reference solution (0.05 per Sodium carbonate (if present)
cent). Insert before Assay
Other tests. Comply with the tests stated under Parenteral
Preparations (Powders for Injection)
Atenolol and Chlorthalidone Tablets. Labelling. Change to:
Page 1531
Labelling. (1) The label states the strength in terms of the
Uniformity of content. Test solution equivalent amount of ceftazidime; (2) the label should state
whether it contains sodium carbonate or arginine.
Change to: Test solution. Disperse one tablet in 15 ml of the
mobile phase with the aid of ultrasound for about 30 minutes,
allow to cool and dilute with the mobile phase to obtain a
solution containing 0.025 per cent w/v of chlorthalidone. Hard Cellulose Capsule Shells. Page 1812
Para 2, Last line
Change from : Drugs and Cosmetics Rules, 1945
Atomoxetine Capsules. Page 1534
to : Drugs Rules, 1945
Add synonym
“Atomoxetine Hydrochloride Capsules”
Insert at the end Chlorothiazide Tablets. Page 1855
Labelling. The label states the strength in terms of the Assay. After chromatographic system, para 1, line 4
equivalent amount of atomoxetine.
Change from : less than 2.0
to : more than 2.0

Azelnidipine. Page 1553

Related substances. Chromatographic system, lines 4 to 8
Diclofenac Gastro-resistant Tablets. Page
Change to: mobile phase: a mixture of 65 volumes of a 2084 (Effective from 15/09/2023)
solution containing 70 volumes of acetonitrile and 30
volumes of methanol and 35 volumes of 0.3 per cent w/v Insert before Related substances
solution of potassium dihydrogen phosphate in water and Dissolution (2.5.2)
adjust mobile phase pH to 5.5 with dilute orthophosphoric
Apparatus No. 2 (Paddle),
acid.
Medium. 900 ml of 0.1 M hydrochloric acid,
Speed and time. 50 rpm and 120 minutes.
At the end of 120 minutes, remove each tablet or the major
Ceftazidime for Injection. Page 1797 portion thereof if the tablet is not intact, from the individual
Insert after para 1 vessels, and subject them to the test under buffer stage.
The injection is constituted by dissolving the contents of the To 0.1 M hydrochloric acid remaining in each vessel, add
sealed container in the requisite amount of sterile Water for 20.0 ml of 5 M sodium hydroxide, and stir for 5 minutes, filter.
Injections, immediately before use. Dilute the filtrate, if necessary, with the dissolution medium
and measure the absorbance of the filtrate at the maximum
Identification. B about 276 nm (2.4.7). Calculate the content of C14H10Cl2NNaO2
Change to: B. In the test for arginine, the principal peak in in the medium from the absorbance obtained from a solution
the chromatogram obtained with the test solution corresponds of known concentration of diclofenac sodium IPRS prepared

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INDIAN PHARMACOPOEIA COMMISSION AMENDMENT LIST-03 TO IP 2022

by dissolving 68 mg of diclofenac sodium IPRS in 10.0 ml of Buffer solution. Dissolve 68 g of potassium dihydrogen
0.1M sodium hydroxide and dilute to 100.0 ml with water. orthophosphate in 950 ml of water, adjusted to pH 3.5 with
Dilute 2.0 ml of the solution to 100.0 ml with a mixture of 90 orthophosphoric acid and dilute to 1000 ml with water.
volumes of 0.1M hydrochloric acid and 2 volumes of 5M Chromatographic system, line 4
sodium hydroxide.
Change from : phosphate buffer pH 3.5
Complies with the acceptance criteria given under acid stage.
to : buffer solution
B. Apparatus No. 2 (Paddle),
Medium. 900 ml of phosphate buffer pH 6.8 prepared by
mixing 75 volumes of 0.1M hydrochloric acid and 25 volumes
of 7.6 per cent w/v of tribasic sodium phosphate in water, Ketoprofen Capsules. Page 2670
adjusted to pH 6.8 with 2M hydrochloric acid or 2M sodium Related substances.
hydroxide,
Speed and time. 50 rpm and 45 minutes. Insert before Solvent mixture

Withdraw a suitable volume of the medium and filter. Dilute Buffer solution. Dissolve 68 g of potassium dihydrogen
the filtrate, if necessary, with the dissolution medium and orthophosphate in 950 ml of water, adjusted to pH 3.5 with
measure the absorbance of the resulting solution at the orthophosphoric acid and dilute to 1000 ml with water.
maximum at about 276 nm (2.4.7). Calculate the content of Chromatographic system, line 4
C14H10Cl2NNaO2 in the medium from the absorbance obtained
Change from : phosphate buffer pH 3.5
from a solution of known concentration of diclofenac sodium
IPRS prepared by dissolving 68 mg of diclofenac sodium to : buffer solution
IPRS in 10.0 ml of 0.1M sodium hydroxide and dilute to 100.0
ml with water. Dilute 3.0 ml of the solution to 100.0 ml with
the dissolution medium.
Luliconazole. Page 2798
Q. Not less than 75 per cent of the stated amount of
C14H10Cl2NNaO2 in the medium. Related substances. A. For Luliconazole S-E form —
Chromatographic system, line 1and 2
Change from : packed with OD-H (5 μm)
to : packed with cellulose tris-3,5-
Divalproex Gastro-resistant Tablets. Page dimethylphenylcarbamate bonded to porous silica (5 μm)
2144
Assay. Chromatographic system, line 1 and 2
Dissolution. B. Chromatographic system, line 4
Change from : packed with OD-H (5 μm)
Change from : potassium phosphate buffer
to: packed with cellulose tris-3,5-
to : phosphate buffer pH 7.4 dimethylphenylcarbamate bonded to porous silica (5 μm)

Hard Gelatin Capsule Shells. Page 2456 Luliconazole Cream. Page 2800
Para 1, line 9 and 10 Related substances. A. For Luliconazole S-E form —
Change from : Drugs and Cosmetics Rules, 1945. Chromatographic system, line 1and 2
to : Drugs Rules, 1945. Change from : packed with OD-H (5 μm)
to : packed with cellulose tris-3,5-
dimethylphenylcarbamate bonded to porous silica (5 μm)
Assay. Chromatographic system, line 1and 2
Ketoprofen. Page 2669 Change from : packed with OD-H (5 μm)
Related substances. to : packed with cellulose tris-3,5-
Insert before Test solution dimethylphenylcarbamate bonded to porous silica (5 μm)

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AMENDMENT LIST-03 TO IP 2022 INDIAN PHARMACOPOEIA COMMISSION

Luliconazole Lotion. Page 2801 Terazosin Hydrochloride. Page 3753

Related substances. A. For Luliconazole S-E form — Assay. Line 4
Chromatographic system, line 1and 2 Change from : Carry out a blank titration.
Change from : packed with OD-H (5 μm) to : Read the volume added between the 2 points
of inflection.
to : packed with cellulose tris-3,5-
dimethylphenylcarbamate bonded to porous silica (5 μm)
Assay. Chromatographic system, line 1and 2 BIOTECHNOLOGY DERIVED
Change from : packed with OD-H (5 μm) THERAPEUTIC PRODUCTS
to : packed with cellulose tris-3,5-
dimethylphenylcarbamate bonded to porous silica (5 μm)
Rituximab. Page 4669
Identification
Naloxone Hydrochloride. Page 3020
Change from : A. Bioassay
Assay. Line 4
to : A. It complies with the biological activity as
Change from : Carry out a blank titration. described under Assay.
to : Read the volume added between the 2 points E. Deterimine by isoelectric focussing (2.4.33) Capillary
of inflection. Electrophoresis
Last Para
Omeprazole and Domperidone Delete following:

Capsules. Page 3119 It complies with the biological activity as described under
Assay.
Uniformity of content. Line 3 and 4
Tests
Change to: Determine by liquid chromatography (2.4.14), as
described under Assay with the following modifications. Charged variants. Determine by ion-exchange liquid
chromatography (2.4.14) using method A or method B
Test solution. Line 2 and 3
Change from : the mobile phase. Method B

to : the solvent mixture. Last Para

Reference solution (a). Change to: Change from : Integrate all rituximab…………….and basic
peak 1 should not less than 1.0.
Reference solution. A 0.01 per cent w/v solution of
Acidic variants. Acidic variants ≤ 30 per cent
domperidone IPRS in the solvent mixture.
Main peak. Main peak ≥ 40 per cent
Assay. Reference solution, line 4
to : Integrate all rituximab…………….and basic
Change from : the mobile phase. peak should not be less than 1.0.
to : the solvent mixture. Acidic variants ≤ 30 per cent
Main peak ≥ 40 per cent
Glycan Distribution. Determine by capillary electrophoresis
Teneligliptin and Metformin with fluorescence detection (2.4.32). Determine by method
Hydrochloride Prolonged-release A or method B.
Tablets. Page 3738 Method A
Assay. For Metformin hydrochloride — Last Para

Test solution. Line 3 Change from : The percent area of the peaks corresponding
to galactosylatedglycan is not more than 35.0 per cent.
Change from : 80 ml
to : The percent area of the peaks corresponding
to : 800 ml to galactosylatedglycan should be between 35 and 65 per cent.

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INDIAN PHARMACOPOEIA COMMISSION AMENDMENT LIST-03 TO IP 2022

Method B Method A
Last Para Last Para
Change from : The percent area of the peaks corresponding Change from : The percent area of the peaks corresponding
to galactosylatedglycan is not more than 35.0 per cent. to galactosylatedglycan is not more than 35.0 per cent.
to : The percent area of the peaks corresponding to : The percent area of the peaks corresponding
to galactosylatedglycan should be between 35 and 65 per cent. to galactosylatedglycan should be between 35 and 65 per cent.
Method B
Rituximab Injection. Page 4676 Last Para
Change from : The percent area of the peaks corresponding
Tests
to galactosylatedglycan is not more than 35.0 per cent.
Glycan Distribution. Determine by capillary electrophoresis
to : The percent area of the peaks corresponding
with fluorescence detection (2.4.32). Determine by method
to galactosylatedglycan should be between 35 and 65 per cent.
A or method B.