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Pharmacopoeial Tests for Different dosage forms - …

Pharmacophore SolutionsBest of luckBe a passionate Tests for Different dosage formsTablet Uniformity of weightWeigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in Table 2 and none deviates by more than twice that weight of tabletPercentage deviation80 mg or less10 More than 80 mg but less then 250 mg or more5 Uniformity of contentThe tablets comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125% of the average value. If two or three of the individual values are outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%, repeat the determination using another 20 tablets. The tablets comply with the test if in the total sample of 30 tablets not more than three of the individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.

Pharmacophore Solutions Best of luck Be a passionate Pharmacist www.gpatindia.com Pharmacopoeial Tests for Different dosage forms Tablet Uniformity of weight Weigh 20 tablets selected at random and calculate the average weight.

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Transcription of Pharmacopoeial Tests for Different dosage forms - …

1 Pharmacophore SolutionsBest of luckBe a passionate Tests for Different dosage formsTablet Uniformity of weightWeigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in Table 2 and none deviates by more than twice that weight of tabletPercentage deviation80 mg or less10 More than 80 mg but less then 250 mg or more5 Uniformity of contentThe tablets comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125% of the average value. If two or three of the individual values are outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%, repeat the determination using another 20 tablets. The tablets comply with the test if in the total sample of 30 tablets not more than three of the individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.

2 DisintegrationType of capsuleDisintegration timeUncoated Tablets15 minutesfilm-coated30 minutesCoated Tabletsother coated tablets60 hydrochloric acidShould not disintegrate in 120 minutesEnteric-coated Tabletsmixed phosphate buffer pH ,60 and Soluble Tabletswithin 3 minutesEffervescent Tablets5 minutesPharmacophore SolutionsBest of luckBe a passionate SolutionsBest of luckBe a passionate SolutionsBest of luckBe a passionate SolutionsBest of luckBe a passionate SolutionsBest of luckBe a passionate Content of active ingredientsWeight of active ingredients in each capsuleSubract from the lower limit for samples ofAdd to the upper limit for samples g or than less than or Uniformity of weightAverage weight of capsule containPercentage deviationLess than 300 mg10300mg or more Uniformity of content:The capsules comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%.

3 If two or three individual values are outside the limits 85 to 115% of the average value repeat the determination using another 20 capsules. The capsules comply with the test if in the total sample of 30 capsules not more than three individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average Disintegration:Type of capsuleDisintegration timeHard Capsules30 hydrochloric acidShould not disintegrate in 2 hoursEnteric Capsulesmixed phosphate buffer pH minutesSoft Capsules60 minutes


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