Quality control tests for Suspensions

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Oral suspension is defined as liquids containing one or more active ingredients suspended in a suitable vehicle. Suspended particles may slowly separate on standing but can be easily redispersed on slight shaking.

According to British Pharmacopoeia 2009 the tests described for quality control are:

1. Uniformity of dosage units

2. Uniformity of content

3. Uniformity of mass

4. Uniformity of mass of delivered doses from multidose containers

TESTS Uniformity of dosage units Suspensions in single-dose containers comply with the test for uniformity of dosage units, with the test for uniformity of content or uniformity of mass. Uniformity of content After shaking, empty each container completely and carry out the test on the individual contents. They comply with test B for uniformity of content of single-dose preparations. Uniformity of mass Weigh individually the contents of 20 containers, then completely empty the containers and determine the average mass. Not more than 2 of the individual masses deviate by more than 10 per cent from the average mass and none deviate by more than 20 per cent. Uniformity of mass of delivered doses from multidose containers Liquid preparations for oral use supplied in multidose containers comply with the test. Oral drops are not subject to the provisions of this test.

LABELLING The label should contain the name of any added antimicrobial preservative. According to Indian Pharmacopoeia 2007 Tests 1. Uniformity of content 2. Uniformity of weight/volume Uniformity of content Suspension that contain less than 10 mg or less than 10 per cent of active ingreient comply with the following test. Empty each container and carry out the test on the active ingredients. Determine the content of active ingredient(s) of each of 10 containers taken at random using the method given in the monograph or by any other suitable analytical method. The preparation complies with the test if the individual values thus obtained are all between 85 to 115 per cent of the average value. The preparation fails to comply with the test if more than one individual value is outside the limits 85 to 115 per cent of the average value or if any one individual value is outside the limits 75 to 125 per cent of the average value. If one individual value is outside the limits 85 to 115 per cent but within the limits 75 to 125 per cent of the average value, repeat the determination using another 20 containers taken at random. The preparation complies with the test if in the total sample of 30 containers not more than 3 individual values are outside the limits 85 to 115 per cent and not more than one is outside the limits 75 to 125 per cent of the average value. Uniformity of weight/volume Oral Liquids comply with the test for contents of packaged dosage forms. Storage Store Oral Liquids or powders and granules for the preparation of Oral Liquids in well-closed containers at temperatures not exceeding 30o. Labelling If Oral Liquids are supplied as drops, the label must contain the number of drops per g of preparation if the dose is stated in drops, or the number of drops per ml of preparation if the dose is stated in volume.

The label should state that the:

(1) the contents are meant for preparation of an Oral Liquid

(2) the directions for preparing the Oral liquid including the nature and quantity of the liquid to be used

(3) the conditions under which the constituted solution should be stored

(4) the period during which the constituted Oral Liquid may be expected to remain satisfactory for use when prepared and stored in accordance with the manufacturer's recommendations

(5) the strength in terms of the active ingredient(s) in a suitable dose-volume of the constituted preparation.

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According to European Pharmacopoeia quality control tests are described as follows

TESTS

1. Uniformity of content

2. Uniformity of mass

3. Dose and uniformity of dose of oral drops

4. Deliverable mass or volume

5. Uniformity of mass of delivered doses from multidose containers

Uniformity of content Unless otherwise prescribed or justified and authorised, single-dose preparations that are suspensions comply with the following test. After shaking, empty each container as completely as possible and carry out the test on the individual contents. They comply with test B for uniformity of content of single-dose preparations.

Uniformity of mass Single-dose preparations that are solutions or emulsions comply with the following test : Weigh individually the contents of 20 containers, empty it completely, and determine the average mass. Not more than 2 of the individual masses deviate by more than 10 per cent from the average mass and none deviates by more than 20 per cent. Dose and uniformity of dose of oral drops Into a graduated cylinder, introduce by means of the dropping device or by means of measuring device the number of drops usually prescribed for one dose. The dropping speed does not exceed 2 drops per second. Weigh the liquid, repeat the addition, weigh again and carry on repeating the addition and weighing until a total of 10 masses are obtained. No single mass deviates by more than 10 per cent from the average mass. The total of 10 masses does not differ by more than 15 per cent from the nominal mass of 10 doses. If necessary, measure the total volume of 10 doses. The volume does not differ by more than 15 per cent from the nominal volume of 10 doses. Deliverable mass or volume Liquid preparations for oral use supplied in single-dose containers comply with the test. Uniformity of mass of delivered doses from multidose containers Liquid preparations for oral use supplied in multidose containers comply with the test.

PRODUCTION During the development of a preparation for oral use, the formulation which contains an antimicrobial preservative, the effectiveness of the preservative should be demonstrated. A suitable test method together with criteria for judging the preservative properties of the formulation are provided in the text on Efficacy of antimicrobial preservation In the manufacturing, packaging, storage and distribution of suspension, suitable means are taken to ensure their microbial quality; recommendations on this aspect are provided in the text on Microbiological quality of pharmaceutical preparations (5.1.4).

LABELLING

The label states : 1) The method of preparation of the solution or suspension, 2) The conditions and the duration of storage after constitution. 3) The label states the name of any added antimicrobial preservative. References: Indian pharmacopoeia 2007 British pharmacopoeia 2009 European pharmacopoeia 2005 This blog does not contain plagiarised material.

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Author: Sona Singh

Comments

P.V.ABHIGNA's picture

Dear Sona, Thats a preety good blog. Thanq for the info........Waitin 4 somethin new......

ABHIGNA.P.V.

PAVAN KUMAR's picture

fne

R PAVAN KUMAR

Sandeep Kongara's picture

what about US Pharmacopoeia?