TABLET WEIGHT VARIATION AND UNIFORMITY OF WEIGHT
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Tablet weight is mainly affected by factors such as tooling of the compression machine,head pressure,machine speed and flow properties of the powder.Inconsistent powder or granulate density and particle size distribution are common sources of weight variation during compression.
Variation between tablet with respect to dose and weight must be reduced to a minimum.Uniformity of weight is an in process test parameter which ensures consistency of dosage units during compression.
Test Procedure
Weigh individually 20 units selected at random and calculate the average weight.Not more than two of the individual weights deviates from the average weight by more than the percentage given in the pharmacopea and none deviates by more than twice that percentage.IP/BP & USP limits for tablet weight variation is given below.
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IP/BP
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Limit
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USP
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80
mg or less
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± 10%
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130mg
or less
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|
More
than 80mg or Less than 250mg
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±
7.5%
|
130mg
to 324mg
|
|
250mg
or more
|
±
5%
|
More
than 324mg
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The limits should be like this
ReplyDelete±10%, ±7.5% and ±5%, because a limit, in general should have lower to upper values.
Greetings what is the deference between ±10%, ±7.5% and ±5 and when we use 7.5 % , 10 % and 5 %
DeleteGreeting what is the deference between we use 7.5%,10% and 5%
DeleteYou are absolutely right..... A limit in general should have lower & upper values.Blog have been updated accordingly. Thanks for your valuable comments...
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DeleteSir, please if you can clarify that answer in a comment we will be much thankfull because i cannot find that answer in the blog please sir,,
DeleteWhat is the difference between weight variation, uniformity of weight, uniformity of dosage unit and range of mean weight?
ReplyDeleteAlso, is there any circumstances that allow different upper and lower limit?
Thank you.
“Uniformity of dosage unit” is defined as the degree of uniformity in the amount of the drug substance among dosage units. Uniformity of dosage units can be demonstrated by either of two methods, 1). Content Uniformity ( by assay test) or 2). Weight Variation.
ReplyDeleteRefer USP <905> uniformity of dosage units
the limits mentioned under USP is for weight variation for dietary supplements. does this apply to all other tablets? as mentioned by u in USP "Uniformity of dosage units can be demonstrated by either of two methods, 1). Content Uniformity ( by assay test) or 2). Weight Variation.". But under weight variation they are calculating content. CLARIFY.
Deletewhat are the usefulness of uniformity of weight test in pharmacy
ReplyDeleteMay I know which edition of BP and USP for the table above?
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ReplyDeleteIs there any method or any systems should we get just zero percent weight variation tablet? & if we can get this then what are the advantages of that?
ReplyDeleteHow much tablets fall range of limit and that's fall limit ?
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Deletewhat is the importance of uniformity of weight test in pharmacy
ReplyDeleteBecause uniform active
Deleteingriedent is necessary for therapeutic effect.
Why are coated tablets exempted from weight variation test?
ReplyDeleteThe applicable tolerance limit should be applied on the calculated average value or on the nominal weight value of the tablet.
ReplyDeleteIn Many companies they are calculating the limit based on the tablet's nominal weight.
ReplyDeleteany bdy tell the relationship b/w weight variation nd therapeutic activity of a dosage form
ReplyDeleteWhen active ingriedent less or more than the following value (range)so may cause toxicity in the body.or no therapeutic effect because ur drug not achieve the therapeutic level.
Deleteiif you use 10 units will the limits still apply?
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Is this according to USFDA.
ReplyDeleteWhat USFDA says, weight variation should be against average weight or standard weight?
i ALSO HAVE THE SAME QUESTION??
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DeleteI would like to know weight variation limit sachet .fill wt 1.5 gr. It is nutrCutical product reg t r k prasad
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ReplyDeleteWhy only 20 tablets are taken why not more than less than 20 taken?
ReplyDeleteMay I know why 10 or 20 tablets used for group weight?
ReplyDeletewhy we take 20 tablets for average weight ???????????
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DeleteWhat is the weight variation for sugar coated tablet.?
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Can i know formula for weight deviation
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Why only 20 tablets are taken why not more than less than 20 taken?
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May I know what is the advantage of the weight variation of tablet in In-process control?
ReplyDeleteI want to clarify this to you , weight variation during Tablets IPC is highly important in order to achieve patient therapeutic effect .If there is variation in weight then active ingredients per tablet will vary above or below the limit ,this out of limit tablet when taken to human body then therapeutic efficacy can be effected or desired effect can't be achieved
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Please can someone help me with the importance of uniformity of weight test in pharmacy?
ReplyDeleteThe target of manufacturing process is to get predetermined specifications, if we consider the mixing process give us a uniform powder, then dosage form weight represent the content of active material in this weight. if weight is less than or greater than nominal then the active material will be deviated by the same difference in each dose and assay variance achieved and the test of uniformity of dosage units may be fail and may lead the process to be not capable due to this variance. Also average weight shall be within limit to achieve predetermined process yield, so you shall do the test of uniformity of weight "mass" to achieve uniformity of dosage units, process capability and process yield within limit.
Deleteif weight is less than 10 mg than?
ReplyDeletePlease are the limits mentioned under USP is general for all tablets and capsules or for Dietary supplements only. Please Reply
ReplyDeletewhy are coated tablets exempt from weight variation?
ReplyDeleteThe tablet core is the important part of the dosage form. If its weight and content uniformity are accurate (e.g., within 5%) then the patient`s clinical needs (safety and efficacy) can be assumed to be taken care. On the other hand, film coating is generally for appearance and the coating process is not very uniform. Hence the weight of film coated tablet is collected for information only.
ReplyDeleteI am working as coating supervisor , as I have observed film coating is just for appearance to enhance customer acceptability ,while in sugar coating or enteric coating weight uniformity is important to protect Active ingredients content uniform ly .e.g Neuromet 500mcg contains mecobalmine which is light sensitive .till compression stage it is manufactured under controlled light after compression stage it shipped for sugar coating where it gets sugar coating and thus free to transport in uncontrolled light .
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For any package contents or weights should not be less than specified. There is no lower limit for 25 kg pack.min contents should be 25 kg net.
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Why take 20 tablets for weight variation. Please reply
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Who knows what chapter of USP describes 'Weight variation'?
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How would you know whether batch of tablets investigated meet with required standard(s)
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