What is uniformity of mass?
What is uniformity of mass?
SINGLE-DOSE PREPARATIONS. Weigh individually 20 units taken at random or, for single-dose preparations presented in individual containers, the contents of 20 units, and determine the average mass.
How is uniformity of weight calculated?
Then, tablets was weighed individually and for each tablet, the percentage of deviation of its weight from the average weight was determined….Capsule.
| Average Net Weight of Capsule | Deviation (%) | Number Of Tablets |
|---|---|---|
| Less than 300 mg | ±10.0 ±20.0 | Minimum 18 Maximum 2 |
| 300 mg or more | ±7.5 ±15.0 | Minimum 18 Maximum 2 |
What is T value in content uniformity?
(i) Solid, Semi-Solid and Liquid dosage forms: The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1 %. Unless otherwise stated, T is 100.0%, or T is the manufacturer’s approved target content per dosage unit.
What is the difference between assay and content uniformity?
The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously. Furthermore, the evaluation procedure of content uniformity tests is the same for all units.
How do you do content uniformity?
Uniformity of Content is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.
What is the difference between content uniformity and assay?
What is friability formula?
Formula for friability test use in tablets: w1= Initial weight of tablets or weight before test. w2= Final weight of tablets or weight after test. Friability Limits: According to USP,IP and BP It should be Not more than 1.0%
What is weight uniformity test?
INTRODUCTION THE British Pharmacopaeia 1953 includes a test for the uniformity of weight of tablets which requires, that when the tablets in a sample of 20 are weighed singly, not more than 2 deviate from the average weight by a percentage greater than that specified and no tablet deviates by more than double that …
How do you do Content Uniformity?
Is the mass variation test for content uniformity required?
The test for content uniformity is required for all dosage forms not meeting the above conditions for the mass variation test.
How is the uniformity of mass of single-dose preparations determined?
Uniformity of mass of single-dose preparationsEUROPEAN PHARMACOPOEIA 6.0 01/2008:20905 2.9.5. UNIFORMITY OF MASS OF SINGLE-DOSE PREPARATIONS Weigh individually 20 units taken at random or, for single-dose preparations presented in individual containers, the contents of 20 units, and determine the average mass.
What do you mean by uniformity of dosage units?
The term “Uniformity of dosage unit” is defined as the degree of uniformity in the amount of the active substance among dosage units. Therefore, the requirements of this chapter apply to each active substance being comprised in dosage units containing one or more active substances, unless otherwise specified elsewere in this Pharmacopoeia.
What do you call non uniformity in composition?
Non-uniformity in composition seen in ingots is called segregation. Based on the length scale of composition variation, segregation can be divided into two categories, i.e., macrosegregation and microsegregation. Figure 4.11 (p. 212) shows some common types of macrosegregation that can occur over large distances in an ingot [17].