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 weight.
What is the maximum weight variation allowed in a capsule?
Question: Weight Variation is allowed for hard capsules, uncoated tablets, and film–coated tablets containing 25 mg or more of the drug substance comprising 25% or more of the weight of the dosage unit.
Are there limits for the permissible variations in the weight of tablets?
The following tests provide limits for the permissible variations in the weights of individual tablets or capsules, expressed in terms of the allowable deviation from the average weight of a sample.
What is content uniformity and weight variation?
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 many intact capsules do you weigh?
Weigh 20 intact capsules individually, and determine the average weight. The requirements are met if each of the individual weights is within the limits of 90% and 110% of the average weight.
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 ...
What is the weight variation?
In the case of pharmaceutical dosage forms, the weight variation test (also referred to as uniformity of dosage units) is a non-destructive test that compares the individual weights of a sample of tablets with the average weight of the selected sample.
How is weight variation calculated?
Weigh the emptied shells individually, and calculate for each capsule the net weight of its contents by subtracting the weight of the shell from the respective gross weight. Determine the average net content from the sum of the individual net weights.
What is the USP limit for content uniformity?
The USP acceptance criteria for content uniformity states that the relative standard deviation (RSD) of a sample of 30 units should not exceed 7.8%.
What is weight variation in pharma?
This means that a volume is dosed, but the quality requirement is the weight. Hence, weight variations in a limited extent are quite normal due to variations in the density of the powder material and to a partially incomplete filling of the dies. The pharmacopoeias specify the acceptable level of weight variations.
Why does weight variation occur?
Weight variation occurs because at higher press speeds the time for a homogeneous die filling is too short. Forced feeding in nearly all cases improves the situation dramatically.
What is the difference between content uniformity and weight variation?
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 are the specifications for weight variation test as per IP?
The R Values are 0.9366, 0.9364, 0.9680, 0.9974 and 0.9283 respectively.
What is weight variation test of tablets?
Uniformity of Weight/ Weight variation test The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights. The individual weights are compared with the average weight.
What is L1 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.
How do you calculate uniformity weight?
20 tablets are weighed. The average weight was determined....Capsule.Average Net Weight of CapsuleDeviation (%)Number Of TabletsLess than 300 mg±10.0 ±20.0Minimum 18 Maximum 2300 mg or more±7.5 ±15.0Minimum 18 Maximum 2Dec 17, 2015
What is content uniformity in pharma?
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.
What is weight uniformity test?
Test of uniformity of weight (mass) is carried out to tablets and capsules to ensure accurate and consistent dosage form to be administered by patients. For Tablets. Based on the result, the tablets used have an average weight of 585.7 mg which is under the category of 'more than 250 mg'. Average Net Weight of Capsule.
How do you perform a weight variation test on a tablet?
Uniformity of Weight/ Weight variation test The test for uniformity of weight is performed by weighing individually 20 tablets randomly selected from a tablet batch and determining their individual weights. The individual weights are compared with the average weight.
What is the weight of a tablet?
The average tablet weights of American tablets were between 0.3235 and 0.2200 g, but those of the Japanese were consistently close to 0.25 g. ... ... < 0.05).
What is the friability test?
Friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit. This testing involves repeatedly dropping a sample of tablets over a fixed time, using a rotating wheel with a baffle.
What is USP 1251?
USP General Chapter 1251 provides detailed information regarding qualification and operation of the instrument. While the chapter is specifically written for analytical balances, most of the information presented can also be applied to balances of higher capacity, such as precision balances or bench scales.
What is the third requirement for weighing instruments?
Calibration, the third requirement, is defined in the International Vocabulary of Metrology (VIM) [5], and it establishes, for weighing instruments, a relationship between the mass value of reference weights and the balance indication including the associated measurement uncertainties.
What is the importance of accuracy in weighing?
Accurate weighing is key for any quality-relevant weighing application. The USP has defined in its General Chapter 41 clear requirements that should ensure that any weighing application within its scope does not significantly contribute to any overall analytical error. Besides using a calibrated balance, requirements for repeatability and accuracy are established and characterized by an assessment against a specified tolerance (0.10 %). As an important consequence of the repeatability test, the minimum weight can be calculated. This minimum weight describes the smallest amount of net substance that can be weighed while complying with the tolerance requirement.
What is weighing in QC?
Weighing is one of the key activities carried out in every QC laboratory. Usually, it is one of the first parts of a whole analysis chain, such as when a sample or a standard is prepared for HPLC or qNMR analysis. As any weighing errors have the potential to propagate through the whole analysis and deliver an inaccurate final result, the United States Pharmacopeia (USP) has set stringent requirements for balances used for weighing analytes for quantitative measures. A recent update effective August 1, 2019 underscores the need for accuracy and emphasizes the concept of minimum weight as basis for accurate weighing processes.
What is the smallest standard deviation?
Note that the smallest standard deviation ( s) that may be used for the assessment against the 0.10 % repeatability requirement and for the calculation of minimum weight is 0.41 d , where d is the digital increment (readability) of the balance. This lower limit is based on the rounding error of a digital indication.
What is the repeatability acceptance criterion for mass?
Based on the repeatability acceptance criterion, (2 x s ) / (smallest net weight) ≤ 0.10 %, all masses equal or larger than (2 x s ) / (0.10 %) conform with this requirement. The smallest mass that satisfies this criterion is called minimum weight:
When was the first USP published?
Capitol (11 of the 16 delegates – all physicians – present) [3]. The first USP was published on December 21, 1820. Artist: Robert Thom.
What is the default test for weight variation?
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.
When was the General Chapter of the USP revised?
The revision of General Chapter <905> that became official on January 1, 2007, was initially proposed in Pharmacopeial Forum 32 (4) [July–August 2006] and made official through the Sixth Interim Revision Announcement to USP 29–NF 24 in Pharmacopeial Forum 32 (6) [November–December 2006]. The official text includes changes based on the comments received.
What is a harmonized chapter?
Answer: The harmonized chapter text applies to any monograph, new or existing, that includes a test for Uniformity of Dosage Units.
How many dosage units are in a content uniformity test?
Answer: Content Uniformity testing can be performed in two stages. The first stage has a total of 10 dosage units tested, and an additional 20 dosage units are tested to complete testing at the second stage. L1 is used as the limit for the acceptance value for both stages of test. L2 is used only in the second stage of testing where a total of 30 dosage units have been tested, and it is only used in the calculation of the allowed limits for individual dosage unit content.
What is the tolerance interval for content uniformity?
For content uniformity, this would be the distribution of content and the intent is to form an interval about the label claim within which a specified proportion of units would fall. Technically, an interval (a, b) is a 95% (the "confidence") tolerance interval for 90% of the distribution (the "coverage") if 95% of such intervals with repeated sampling would cover at least 90% of the distribution. The tolerance intervals can be parametric or nonparametric. Parametric intervals are based on an assumed distribution, usually the normal. When assuming the normal distribution, two–sided tolerance intervals are of the form, , where is the average, S the standard deviation, and k depends on the coverage, confidence, and sample size. (The multiplier, k, becomes smaller as sample size increases, but never to 0. For 95% coverage, for example, it will decrease to 1.96.) This is the form of the criteria used in General Chapter <905>.
When was the USP 28 NF 23 revised?
USP published a revised, harmonized General Chapter <905> on pages 2505–2510 of USP 28–NF 23 with an implementation date of April 1, 2006. This chapter contains the global harmonized text approved by the Pharmacopeial Discussion Group (PDG) as well as USP–specific national text. The PDG consists of USP, the Japanese Pharmacopeia, and the European Pharmacopeia.
What is L1 in a test?
L1 is used as the limit for the acceptance value for both stages of test. L2 is used only in the second stage of testing where a total of 30 dosage units have been tested, and it is only used in the calculation of the allowed limits for individual dosage unit content.
