Indian Pharmacopoeia Commission Amendment List -001 for 2018

Indian Pharmacopoeia Commission Amendment List -001 for 2018

The 8th Edition of the Indian Pharmacopoeia will come into effect from 1 April 2018. Based on Scientific inputs some monographs required to be upgraded. Therefore the Indian Pharmacopoeia Commission has published an Amendment List-001 which contains these amendments. Pharmaceutical manufacturers will need to be compliance with IP-2018

Amendment List 001 to IP-2018

2.4.26. Solubility (Page 224)

Busulphan

Change from:  Freely soluble in acetone, in chloroform, and in acetonitrile; very  slightly soluble in water, in ethanol (95 percent) and in the ether

 To:   Sparingly soluble in acetone; slightly soluble in ethanol (95 percent); very slightly soluble in water

Aminophylline Prolonged-release Tablets (Page1209)

Para 1, line 1

Change from:           Alprazolam Prolonged-release Tablets

 To:                              Aminophylline Prolonged-release Tablets

 

Carboxymethylcellulose Sodium (Page 1491)

Labeling

Change from:    The label states (1) the apparent viscosity in millipascal seconds   of a 2 percent w/v solution or, where the viscosity is low, the concentration of the solution to be used and the apparent viscosity in mPa s; (2) that the contents are not intended for use   in the manufacture of an injectable preparation.

To:    The label states the apparent viscosity in millipascal seconds of a 2 percent w/v solution or, where the viscosity is low, the concentration of the solution to be used and the apparent viscosity in mPa s.

Corn Oil (Page 1698)

Labeling

Change from: The label states (1) the name and quantity of any added antioxidant; (2) whether the content is suitable for use in the manufacture of parenteral preparations.

 The label states the name and quantity of any added antioxidant.

Cottonseed Oil (Page 1704)

Labeling

Change from:  The label states (1) the name and quantity of any added antioxidant, (2) whether the contents are suitable for use in the manufacture of parenteral preparations.

 To: The label states the name and quantity of any added antioxidant.

Dextromethorphan Hydrobromide (Page 1792)

Related substances, under a Chromatographic system

-mobile phase:

Change from:  dissolve 3.11 g of docusate sodium in a mixture of 400 ml of water and 600 ml of acetonitrile. Add 0.56 g of ammonium nitrate, adjusted to pH 2.0 with glacial acetic acid,

 To:  dissolve 3.11 g of docusate sodium in a mixture of 400 ml of water and 600 ml of acetonitrile. Add 0.56 g of sodium nitrate, adjusted to pH 2.0 with glacial acetic acid,

Dextromethorphan Hydrobromide Syrup (Page. 1793)

Assay, under a Chromatographic system

-mobile phase:

Change from: a filtered and degassed solution of 0.007 M ammonium nitrate in    a mixture of 70 volumes of acetonitrile and 30 volumes of water adjusted to pH 3.4 with glacial acetic acid,

 To: a filtered and degassed solution of 0.007 M sodium nitrate in a  mixture of 70 volumes of acetonitrile and 30 volumes of water adjusted to pH 3.4 with glacial acetic acid.

Diclofenac Sodium and Paracetamol Tablets (Page 1811)

4-Aminophenol: Test solution

Change from:  Weigh and powder 20 tablets. Weigh and transfer a quantity of powder containing 25 mg of paracetamol to 25.0 ml volumetric flask. Add 6.3 ml of solvent mixture A, sonicate for 10 minutes and dilute to volume with a mixture of equal volumes of solvent mixture A and solvent mixture B.

 To:  Weigh and powder 20 tablets. Weigh and transfer a quantity of powder containing 25 mg of paracetamol to 25.0 ml volumetric flask. Add 6.3 ml of solvent mixture A, sonicate for 10 minutes and dilute to volume with a mixture of equal volumes of solvent mixture B and solvent mixture C.

Under Chromatographic system

After line 2, add the following – column temperature: 35º,

Diethylene Glycol Monoethyl Ether (Page 1826)

Related substances, under a Chromatographic system

Change from:           injection volume: 1 µl.

 To:                              injection volume: 1 ml.

Labelling                   Delete the requirement.

Escitalopram Oxalate and Clonazepam Tablets (Page 1977)

Dissolution Reference solution. Line 1

Change from: Dissolve an accurately weighed quantity of escitalopram oxalate and clonazepam RS in the dissolution medium and dilute with the dissolution medium…….

 To: Dissolve an accurately weighed quantity of escitalopram oxalate RS and clonazepam RS in 5.0 ml methanol and dilute with the dissolution medium to……

Gelatin (Page 2155)

Labeling

Change from: The label states, where applicable, that the material is suitable for the preparation of pessaries and suppositories and, if so, the jelly strength.

 To: The label states the jelly strength.

Levetiracetam (Page 2407)

Enantiomeric purity: After chromatographic system, Para 2, line 4

Change from:           2.0

 To:                              2.4

Levofloxacin Hemihydrate (Page 2422)

Water (2.3.43)

Change from:           Not more than 3.0 percent, determined on 0.1 g.

 To:                              Not more than 3.0 percent, determined on 0.2 g.

Levonorgestrel and Ethinyloestradiol Tablets (Page 2429)

Uniformity of content

Change from: Complies with the test stated under Tablets. Carry out the procedure described under Assay using the following solutions.

Test solution. Disperse one tablet in 5 ml of the mobile phase with the aid of ultrasound for 30 minutes, cool and dilute to 10.0 ml with the mobile phase. Shake to mix and centrifuge, use the clear supernatant liquid.

Reference solution (a) Weigh accurately a quantity of levonorgestrel RS containing 100 times the stated amount of Levonorgestrel per tablet, dissolve in sufficient methanol (70 percent) to produce 200.0 ml. Take 2.0 ml of this solution, add 2.0  ml of the internal standard solution and use the resulting solution.

 Reference solution (b). Weigh accurately a quantity of ethinyloestradiol RS containing 100 times the stated amount of Ethinyloestradiol per tablet, dissolve in sufficient methanol (70  percent) to produce 200.0 ml. Take 2.0 ml of the solution, add 2.0 ml of the internal standard solution and use the resulting solution.

To:                               Complies with the test stated under Tablets.        

                                    Carry out the procedure described under Assay using the following solutions.

  Test solution. Disperse one tablet in 5 ml of the mobile phase with the aid of ultrasound for 30 minutes, cool and dilute to 10.0 ml with the mobile phase. Shake to mix and centrifuge, use the clear supernatant liquid.

Assay After chromatographic system, Para 1, line 1

Change from:           Inject the reference solution.

To:                               Inject the reference solution (c).

Para 2, line 1.

Change from:           Inject the reference solution and the test solution.

 To:                              Inject the reference solution (c) and the test solution.

Metoprolol Succinate Prolonged- release and Amlodipine Tablets (Page 2585)

Identification, line 3

Change from:           reference solution

 To:                              reference solution (c)

Oleic Acid (Page 2774)

Labeling

Change from:  The label states (1) where applicable, that it is used for external use only; (2) the name and concentration of an added antioxidant.

 To: The label states the name and concentration of an added antioxidant.

Rosuvastatin Calcium and Ezetimibe Tablets (Page 3143)

Para 1, line 3

Change from:           rosuvastatin calcium,

 To:                              rosuvastatin,

Soyabean Oil (Page 3250)

Labeling

Change from: The label states (1) the name and quantity of any added antioxidant, (2) whether the contents are suitable for use in the manufacture of parenterals.

 To:  The label states the name and quantity of any added antioxidant.

Telmisartan and Amlodipine Tablets (Page 3321)

Assay: Reference solution (a), line 1

Change from:           0.008

 To:                              0.08

Telmisartan and Hydrochlorothiazide Tablets (Page 3323)

Related substances Last Para, line 14

Change from:           0.002 times

 To:                              0.005 times

Last Para, line 15

Change from:           0.2 percent

 To:                              0.5 percent

Arachis Oil (Page 3739)

Labeling

Change from:  The label states (1) whether the contents are suitable for use in the manufacturer of parenteral preparations; (2) when the addition of antioxidants is authorized, the name and quantity of the added antioxidants.

 To:                              The label states the name and quantity of the added antioxidants.

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