| We analysed the medicines for drug content by validated chromatographic methods, and compared our results with pharmacopoeial requirements. |
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| The results met pharmacopoeial specii cations, and the tablets are suitable for oral administration. |
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| The method is handy, fast and informative with a good correlation with pharmacopoeial and other frequently used methods. |
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| All tablets were characterized for assay, weight variation, hardness and friability and were found to meet the pharmacopoeial standards. |
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| Additional validation of a new or changed pharmacopoeial method is not required. |
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| In the absence of a pharmacopoeial monograph a specification shall be proposed and justified. |
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| In case of a change in the sterilisation process, the change is to a standard pharmacopoeial cycle only. |
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| In the absence of a pharmacopoeial monograph, a specification shall be proposed and justified for the packaging material. |
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| Inorganic impurities are normally detected and quantified using pharmacopoeial or other appropriate procedures. |
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| The selected formulation proved to be consistent with pharmacopoeial requirements. |
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| The delivered dose uniformity test should be conducted according to an accepted pharmacopoeial method, or a suitably validated alternative. |
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| Specifications are of pharmacopoeial or equivalent status and are in compliance with the current marketing authorization. |
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| The deleted test has been demonstrated to be redundant with respect to the remaining tests or is no longer a pharmacopoeial requirement. |
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| The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated were within the acceptable limits. |
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| With the exception of a potency assay or a bioassay, transfer of the QC testing responsibilities for a pharmacopoeial assay to a different facility within the same company. |
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| Also provided should be the results of applicable pharmacopoeial test, including biological safety, and the relevant extraction and coring studies. |
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| The change is within the range of approved acceptance criteria or has been made to reflect new pharmacopoeial monograph specifications for the excipient. |
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| Borrowers should specify in the bidding documents the type of plastic that can be used for containers in compliance with pharmacopoeial standards. |
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| With respect to the use of pharmacopoeial methods and acceptance criteria, the value of this guidance is linked to the extent of harmonisation of the analytical procedures of the pharmacopoeias. |
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| Clarification is required around current practice for acceptance of microbial limits based on acceptance of pharmacopoeial standards for compendial products. |
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