What are the weight variation limits according to 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 |
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.
What is limit of uniformity of content as per USP?
Similarly one may ask, what is 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.
What are the USP’s requirements for weighing applications?
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.
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%.
What is the limit of weight variation based on British Pharmacopoeia?
IP/BP & USP limits for tablet weight variation is given below....IP/BPLimitUSPMore than 80mg or Less than 250mg± 7.5%130mg to 324mg250mg or more± 5%More than 324mg1 more row•May 9, 2012
What is the weight variation test?
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.
What is the limit of uniformity of content as per USP?
The requirements are met if not more than 1 unit of the 30 is outside the range of 85.0% to 115.0% of label claim, and no unit is outside the range of 75.0% to 125.0% of label claim and the RSD of the 30 dosage units does not exceed 7.8%. 1.
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 is limit of friability in IP and USP?
Friability Limits: According to USP, IP and BP, It should be Not more than 1.0%
What is weight variation in pharmaceutical industry?
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.
What is AV value in content uniformity?
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.
How do you calculate uniformity weight?
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 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 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.
What is assay tablet?
An assay is an investigative (analytic) procedure for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte).
Why are coated tablets exempted from weight variation test?
In the case of film-coated tablets, the effect of coating weight on the mass variation test was very small because the rate of coating in comparison to the whole weight was small. In the case of hard capsules, the usage of whole formulation weight resulted in underestimation of variations of filling weight.
What is uniformity content?
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.
Why is net sample weighing above minimum weight?
Crucially, weighing net samples sufficiently above the minimum weight is recommended in order to take balance fluctuations into account. The use of a safety factor ensures that weighing always take place in the safe weighing range of the balance for a given application.
What is the purpose of the USP balances?
The United States Pharmacopeia (USP) General Chapters <41> "Balances" and <1251> "Weighing on an Analytical Balance" aim to ensure weighing accuracy and eliminate unnecessary over-testing for US pharmaceutical manufacturers and suppliers.
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 USP 29 NF 24 revised?
The revised, harmonized version (pages 2780–2785) was to become official on January 1, 2007, but was superseded by the subsequent revision in the Sixth Interim Revision Announcement to USP 29–NF 24 in Pharmacopeial Forum 32 (6) [November–December 2006].
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.
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 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.
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.
Status of General Chapter <905>
Revision History and Rationale
- The ICH Steering Committee considers international harmonization of about 10 specific compendial test chapters as critical to attaining full utility of the ICH Q6A guideline. ICH Q6A recommended the harmonization of certain tests for dosage forms, including General Chapter <905>. 1. USP published a revised, harmonized General Chapter <905> on pages 2505–2510 of …
Official Harmonized Chapter <905>
- 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 24in Pharmacopeial Forum 32(6) [November–December 2006]. The official text includes changes based on the comments receiv…
Harmonized Chapter Testing Requirements
- <905> includes Content Uniformity and Weight Variation procedures and acceptance criteria to evaluate uniformity of dosage units. These apply to both newly registered and existing products. 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, an...
Statistical Basis of The New Content Uniformity Criteria
- The primary concept underlying the criteria in the revised <905> Uniformity of Dosage Units is that of statistical tolerance intervals. The general idea of tolerance intervals is to use the available data to form an interval that covers a specified proportion of the distribution underlying the data. For content uniformity, this would be the distribution of content and the intent is to form an inter…
Statistical References
- Further information regarding the statistical basis of the chapter is available in the references noted below. 1. Katori. N, Aoyagi N, Kojima S, A Proposal for Revision of the Content Uniformity Test and Weight Variation Test, PF 23(6), 5325–5333, 1997. 2. Content Uniformity—Evaluation of the USP Pharmacopeial Preview, Members of the Statistics Working Group PhRMA, PF 24(5), 70…
Calculation Examples
- On the following pages are 3 examples involving different outcomes. Please submit comments or further inquiries on this topic to William Brown, Senior Scientist at web@usp.org(link sends email)or +1-301-816-8380.
Frequently Asked Questions
- Question: What is meant by the term "special procedure" as found under Content Uniformity in the official chapter? Answer: Typically, the Content Uniformity determination is made on individual dosage units using the procedure found in the Assay. For certain products, a separate procedure is given in the monograph. Where that is the case, the monograph procedure would be consider…