Stage 6 Harmonization Official December 1, 2011 〈905〉 Uniformity of Dosage Units1 〈905〉 UNIFORMITY OF DOSAGE The test for Content Uniformity is required for all dosage forms not meeting the above conditions for the Weight Variation test. In the third part, indexes based on the test in this study were proposed to evaluate the sedimentation stability and redispersibility. ... suspension will be either pseudoplastic or plastic & it is desirable that thixotropy be associated with these two types of flow. Density Specific gravity or density of the suspension is an important parameter. 400 ® LIQUID (erythromycin ethylsuccinate oral suspension, USP) is supplied in 1 pint bottles (NDC 0074-6373-16) and in 100-mL bottles (NDC 0074-6373-13). Mathematical and technical aspects of a procedure to test this property have been discussed in a preceding article. 24. Shaking intensity. Determination of the redispersibility The redispersibility of a suspension was evalu-ated qualitatively. Redispersibility . I have no experience with this dosage form before. It is used to prepare a diluted suspension, emulsion, or solution of the active ingredient(s) for the prevention and treatment of ectoparasitic infestations of animals. Hydrometers are used to measure the density. 2.2. E.E.S. In order to test the redispersibility of the suspensions, the shaking intensity of the apparatus was adjusted to match the 25th percentile of the population of subjects, in whom acceleration profiles had been measured .Before sampling, containers were shaken for 3 s at 4.2 Hz with an amplitude of 5 cm. Supernatant Redispersibility Sediment Rheology Viscosity Suspension Boundary Velocity of sedimentation Sedimented I have a lot of question around the dissolution test for oral suspension. June 1, 2016 . 1 UNITS 2S (USP34) Table 1. In accordance with USP’s Rules and Procedures of the Council of Experts (“Rules”) and except as provided in Section 7.02 Accelerated Revision Processes, USP publishes proposed revisions to the United States Pharmacopeia and the National Formulary (USP–NF) for public review and comment in Density measurements at a given temperature should be made using well-mixed uniform suspension. USP 39–NF 34, Second Supplement . Both liquid products require refrigeration to preserve taste until dispensed. Fixed volume of each suspension (50 ml) was kept in calibrated tubes which were stored at room temperature for various time intervals (1, 5, 10, 15, 20, 30, 45 days). Mathematical and technical aspects of a procedure to test this property have been discussed in a preceding article. Based on the time and the effort required to convert the sediment to homoge-nous suspension, the formulations were evaluated. As for MR suspensions, we prepare samples with different additives which have been reported applied most commonly in traditional MR suspensions [ 23 – 26 ]. 5.3. ... if we allow 1% variation(as per USP) in dolevered media for 900 ml it range should be 891-909 ml , other thing you have to introduce only about 5-10 ml .not 50 or 100 ml 03-01-2007, 02:34 PM #4. The content of active ingredient of single doses of a suspension depends to a large extent upon the redispersibility of the product. Estolate Oral Suspension, USP. The test consisted of manually shaking the cylinder after the sedimentation experi-ments were completed. Where, Hu is ultimate or final height of sediment as suspension settles, Ho is original height of suspension. The content of active ingredient of single doses of a suspension depends to a large extent upon the redispersibility of the product. Decrease in density indicates the presence of entrapped air with in the structure of the suspension. 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