Weight variation was carried out to ensure that, each of tablets contains the proper amount of drug. The test was carried out by weighing the 20 tablets individually using analytical balance, then calculating the average weight, and comparing the individual tablet weights to the average.

Then, Why dissolution test is performed?

In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.

Considering this, What is limit of weight variation in IP and USP?

IP/BP Limit USP
80 mg or less ± 10% 130mg or less
More than 80mg or Less than 250mg ± 7.5% 130mg to 324mg
250mg or more ± 5% More than 324mg

28 Related Questions and Answers Found 💬

 

What is weight variation test?

6.2 WEIGHT VARIATION 99,100,102

Weight variation was carried out to ensure that, each of tablets contains the proper amount of drug. The test was carried out by weighing the 20 tablets individually using analytical balance, then calculating the average weight, and comparing the individual tablet weights to the average.

What is weight uniformity test?

The weight uniformity test is used to ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch. Furthermore, the uniformity of weight of tablets and capsule indicate the quality control of specific batch of tablets and capsules.

What is limit of weight variation in IP and USP?

Weight Variation Limits IP/BP Limit USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg Weigh individually 20 units selected at random or, for singledose preparations in individual containers, the contents of 20 units, and calculate the average

Why dissolution test is performed?

In the pharmaceutical industry, drug dissolution testing is routinely used to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency of solid oral dosage forms such as tablets, and drug development, i.e., to predict in vivo drug release profiles.

Why is uniformity of weight important?

Uniformity of weight of drug is important because this ensure the even distribution of ingredients in the drug. Uneven distribution may alter the dose in each individual drug and therefore causes a lot of problems such as unable to reach the therapeutic range or exceed the therapeutic range and reach toxic range.

What is s1 s2 s3 in dissolution?

Tablet Dissolution Test in Different Stages (S1, S2 and S3) This is the first stage of the dissolution and known as S1 Stage. In S1 stage dissolved amount of each unit should not be less than Q+5%. It shows that every unit should be above 5% of the specified limit in the individual monograph.

What is acceptance value?

Accepted value is usually a number (or value) that is regarded as true by the general public, scientists, mathematicians, etc. It is often a term that is used in science, especially chemistry. To find percentage error, take the difference of experimental value and accepted value and then divide by accepted value.

What is dissolution of tablets?

Friability testing is used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.

What is stratified content uniformity?

Stratified sampling is the process of selecting units deliberately from various locations within a lot or batch or from various phases or periods of a process to obtain a sample. available for demonstrating blend uniformity (e.g., on-line NIR measurement of in-process blend or dosage units).

Why is uniformity of weight important?

Uniformity of weight of drug is important because this ensure the even distribution of ingredients in the drug. Uneven distribution may alter the dose in each individual drug and therefore causes a lot of problems such as unable to reach the therapeutic range or exceed the therapeutic range and reach toxic range.

Why is a tablet hardness test done?

Tablet hardness testing, is a laboratory technique used by the pharmaceutical industry to determine the breaking point and structural integrity of a tablet and find out how it changes “under conditions of storage, transportation, packaging and handling before usage” The breaking point of a tablet is based on its shape.

What is blend uniformity in pharma?

Definition
BUA is an in-process test that is useful for ensuring the adequacy of the mixing of active pharmaceutical ingredients (APIs) with other components of the drug product. ( FDA Guidance for Industry, ANDAs: Blend Uniformity Analysis)

How do you calculate label claims?

How do you calculate acceptance value?

Calculate the acceptance value by the formula: | M – X . | + ks, in which the terms are as defined in Table 6.02-2.

How do you calculate uniformity weight?

  1. Number of birds weighed = 105.
  2. Average (mean) body weight = 1.320 kg.
  3. 10% of the average body weight = 10% × 1.320 kg = 0.1320 kg.
  4. Upper body weight range = 1.320 kg + 0.1320 kg = 1.452 kg.
  5. Lower body weight range = 1.320 kg – 0.1320 kg = 1.188 kg.

What is the limit of uniformity of content as per USP?

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%.

What is dissolution in pharmaceuticals?

Dissolution is the process by which a solid solute enters in to a solution. In the pharmaceutical industry, it may be defined as “the amount of drug substance that goes into solution per unit time under standardized conditions of liquid/solid interface, temperature and solvent composition”.

What is difference between dissolution and disintegration?

Disintegration is a process of breaking down a substance into tiny fragments to improve its solubility in a solvent. Dissolution, on the other hand, is a process through which solutes dissolve in a solvent. Dissolution is also used predominantly in pharmaceutical industries to check how soluble a drug is in the body.

What is acceptance value?

Similarly, accepted value is a term often used in science or mathematics to mean the value of something that is regarded as true among all scientists or mathematicians. This is different from experimental value, which is the value that results from an individual’s laboratory experiment or an individual’s calculation.

What is dissolution of tablets?

Introduction to Thickness Testing

It is assumed that providing the weight of the tablet is kept within defined limits that the amount of active drug available to the user will remain the same. The weight of a compressed tablet is dependent on three factors: density, diameter and thickness.

What is stratified content uniformity?

On average, tablets weigh under 0.8 kg (1.75 lbs), whilst laptops tend to weigh 2.3 kg (about 5 lbs) and up. Most laptop manufacturers include lightweight versions in their offering, which tend to weigh between 1 kg and 2.7 kg (2 lb and 6 lbs).

How do you calculate uniformity weight?

  1. Number of birds weighed = 105.
  2. Average (mean) body weight = 1.320 kg.
  3. 10% of the average body weight = 10% × 1.320 kg = 0.1320 kg.
  4. Upper body weight range = 1.320 kg + 0.1320 kg = 1.452 kg.
  5. Lower body weight range = 1.320 kg – 0.1320 kg = 1.188 kg.

What is a friability test?

Friability testing is used to test the durability of tablets during packing processes and transit. This involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.

What is a friability test?

Tablet Dissolution is a standardised method for measuring the rate of drug release from a dosage form and the key word here is “standardisation” because for any results to be meaningful, it is essential that all the apparatus used for the testing, produces the same sets of results given all other parameters are equal.

Why friability test is done?

Pharmaceutical usage

Friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit. The result is inspected for broken tablets, and the percentage of tablet mass lost through chipping.

What is uniformity of mass?

Uniformity of mass.

For containers the contents of which weigh more than 100 g, not more than two of the individual masses deviate by more than 5 per cent from the average mass and none deviates by more than 10 per cent.

What is the average weight of a tablet?

On average, tablets weigh under 0.8 kg (1.75 lbs), whilst laptops tend to weigh 2.3 kg (about 5 lbs) and up. Most laptop manufacturers include lightweight versions in their offering, which tend to weigh between 1 kg and 2.7 kg (2 lb and 6 lbs).

What is the purpose of disintegration test?

Disintegration testers are used to test how a drug in pellet form will disintegrate in solution. Like dissolution testers, they permit researchers and medical practitioners to analyze the in vitro breakdown of powdered compounds for quality control purposes.

What is the average weight of a tablet?

Uniformity of mass.

For containers the contents of which weigh more than 100 g, not more than two of the individual masses deviate by more than 5 per cent from the average mass and none deviates by more than 10 per cent.

Why do we have to determine friability of compressed tablets?

Friability (the condition of being Friable) testing is a method, which is employed to determine physical strength of compressed and uncoated tablets upon exposure to mechanical shock and attrition. The strength of a tablet plays a very important role in its marketing and dissolution.

What are the possible causes for weight variation for capsules?

On average, tablets weigh under 0.8 kg (1.75 lbs), whilst laptops tend to weigh 2.3 kg (about 5 lbs) and up. Most laptop manufacturers include lightweight versions in their offering, which tend to weigh between 1 kg and 2.7 kg (2 lb and 6 lbs).