What is the allowable weight tolerance (in % against label claim) for prescription medicines ? Is there any guideline available preferebly EU.
Thank you
The assay limit of active ingredient (API) added in the drug product is generally 90% to 110% of the added amount (label claim) unless otherwise specified in the pharmacopoeia for generic drugs (see individual monographs of the drug products in the respective pharmacopoeia like EP, USP, BP, IP).
If the drug product is not specified in the pharmacopoeia monograph then the assay limit of active ingredient(s) is decided by the manufacturing company, however, it is usually 90% to 110% or 95% to 105% of the labelled / added amount. This allowable weight rolerance (% against label claim) is governed by the Regulatory requirements of that country.
For drugs manufactured for selling in Indian market, this is specified in the Indian Drug & cocmetics Act 1940 and Rules thereunder 1945 (schedule V) which states as follows, (As amended up to the 31
st December, 2016)
Rule 124 Standards of drugs:
(1) For drugs included in the Indian Pharmacopoeia—
(a) The standards for identity, purity and strength shall be those as may be
specified in the edition of the Indian Pharmacopoeia for the time being in force.
(b) In case the standards for identity, purity and strength for drugs are not
specified in the edition of the Indian Pharmacopoeia for the time being in force but
are specified in the edition of the Indian Pharmacopoeia immediately preceding, the
standards for identity, purity and strength shall be those occurring in such
immediately preceding edition of the Indian Pharmacopoeia.
STANDARDS FOR PATENT OR PROPRIETARY MEDICINES (Schedule V)
Patent or proprietary medicines shall comply with the general requirements of the dosage
form under which it falls as given in the Indian Pharmacopoeia. If the dosage form is not included in
the Indian Pharmacopoeia, but is included in any other pharmacopoeia, prescribed for the purpose of
the Second Schedule to the Act, it shall comply with the general requirements of the dosage of
such pharmacopoeia.
The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or
proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled
content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry
formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in
case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents.
(Please verfiy above limits in the current version of The Drug & cosmetics Act 1940 and Rules thereunder 1945)
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For allowable weight tolerance of the content of drug product filled in the container / pack (% against label claim) please refer respective pharmacopoeial limits or according to the weights and measures act requirements of that country.
Thank you. Helpful responses
You are welcome…
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