What is content uniformity testing?
Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.
When content uniformity test is applicable?
Content Uniformity is the default test and may be applied in all cases. The test for Weight Variation is applicable for dosage forms specified as W1, W2, W3, and W4. The requirements for dosage uniformity are met if the acceptance value of the first 10 dosage units is less than or equal to L1%.
How is content uniformity calculated?
The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to L1% and no individual content of the dosage unit is less than (1－ L2 × 0.01)M nor more than (1 ＋ L2 × 0.01)M in Calculation of Acceptance Value under Content Uniformity or under Mass Variation.
What is the limit for content uniformity test?
Limit A (if the average of the limits specified in the potency definition in the individual monograph is 100.0 percent or less) — Unless otherwise specified in the individual monograph, the requirements for dosage uniformity are met if the amount of the drug substance in each of the 10 dosage units as determined from …
What is L1 value in content uniformity?
Acceptance Value and Content Uniformity L1. Maximum allowed acceptance value L1 = 15.0 unless otherwise specified. L2. L2 = 25.0 unless otherwise specified. Maximum allowed range for deviation of each dosage unit tested from the calculated value of M.
What is CU in pharma?
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 does AV mean in content uniformity?
test acceptance value
In methods currently used to ensure the uniformity of dosage. units (UDU) (1), the test acceptance value (AV) is based on. the following formula: AV = M x + ks, where Mis reference value, x is sample mean, k is acceptability constant, and s is sample. standard deviation.
What is thickness of tablet?
Tablet thickness is determined by the diameter of the die, the amount of fill permitted to enter the die cavity, the compaction characteristics of the fill material, and the force or pressure applied during compression.
What is KP in hardness?
Kilopond (kp) – Not to be confused with a pound. A unit of force also called a kilogram of force. Still used today in some applications, but not recognized by the SI system. 1 kilopond = 1 kgf. Strong-Cobb (SC) – An ad hoc unit of force which is a legacy of one of the first tablet hardness testing machines.
What is the friability test limit?
As per the formula, the limits of the friability test shall not be more than 1.0%.
What is unit of hardness?
The SI unit of hardness is N/mm². The unit Pascal is thus used for hardness as well but hardness must not be confused with pressure. The different types of hardness discussed above have different scales of measurement.
How do you convert KP to KG?
Please provide values below to convert kilopond [kp] to kilogram-force [kgf], or vice versa….Kilopond to Kilogram-force Conversion Table.
| Kilopond [kp] | Kilogram-force [kgf] |
|---|---|
| 0.1 kp | 0.1 kgf |
| 1 kp | 1 kgf |
| 2 kp | 2 kgf |
| 3 kp | 3 kgf |
What is friability formula?
The formula for friability test use in tablets: w2= Final weight of tablets or weight after the test.
What is the meaning of HRC in hardness?
All our knives are rated for how hard they are with what is called the Rockwell rating or measurement (aka HRC) of the steel. HRC is clever in its simplicity, it simply measures how much of a dent/mark a diamond point can make in the metal with a measured amount of weight. The smaller the mark the harder the steel.
What is 1.5 kp in KG?
Please provide values below to convert kilopond [kp] to kilogram-force [kgf], or vice versa….Kilopond to Kilogram-force Conversion Table.
| Kilopond [kp] | Kilogram-force [kgf] |
|---|---|
| 0.01 kp | 0.01 kgf |
| 0.1 kp | 0.1 kgf |
| 1 kp | 1 kgf |
| 2 kp | 2 kgf |
Is KP the same as KG?
That is, it is the weight of a kilogram under standard gravity. Therefore, one kilogram-force is by definition equal to 9.80665 N. Similarly, a gram-force is 9.80665 mN, and a milligram-force is 9.80665 μN….
| kilogram-force | |
|---|---|
| Unit of | Force |
| Symbol | kgf |
| Conversions | |
| 1 kgf in … | … is equal to … |
What is friability limit?
What is HRC and HRA?
HRA means Rockwell hardness measured on A scale. HRB means Rockwell hardness measured on B scale. HRC means Rock well hardness measured on C scale.
What is difference between HRC and HRA?
The key difference between HRC and HRB is that the HRC hardness scale uses a spheroconical diamond as its indenter, whereas the HRB hardness scale uses a 1/16 inch ball as the indenter. Moreover, the major load of HRC is 150 kgf, while the major load of HRB is 100 kgf.
How do you convert KP to kg?
Is the Watson U2 statistic a valid test for uniformity?
On the basis of the results observed in this study, the Watson U2 statistic is recommended as a general test for uniformity.
Should we use ectopic criteria for testing uniformity?
It has been shown that a significant part of the criteria traditionally used when testing hypotheses about uniformity, is ectopic relative to a certain type of competing hypotheses. It is stressed that the special criteria for testing uniformity have no obvious advantages over non-parametric agreement criteria used for checking uniformity.
Are tests for uniformity of observation biased?
This paper describes a set of tests for uniformity of observations which are ranked by power. It is shown that most tests commonly used for the hypothesis of uniformity are biased relative to a certain kind of competing hypotheses.
Is a sample form a uniform distribution on the unit interval?
Results from a simulation study of the power of eight statistics for testing that a sample is form a uniform distribution on the unit interval are reported. Power is given for each statistic against four classes if alternatives.