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905 UNIFORMITY OF DOSAGE UNITS USP34
Web2.1.2 Unless the 25 milligrams (mg)/25% threshold limit is met, the use of the Mass/Weight Variation test as an alternative test for Content Uniformity is not ... application, renewal or variation application citing the use of the corresponding text from another pharmacopoeia as referenced in Section 2.1, in accordance with the ... WebThe uniformity of dosage units can be demonstrated by either of two methods, Content Uniformity or Weight Variation (see Table 1). ... number of individual dosage units to determine whether the individual content is within the limits set. The Content Uniformity method may be applied in all cases. ... dick\u0027s sporting goods oxford valley pa
Quality control tests of tablets or Evaluation of tablets
WebApr 25, 2013 · Study now. See answer (1) Best Answer. Copy. 80 mg or less. 10%. More than 80mg or Less than 250mg. 7.5%. 250mg or more. WebThe 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 … WebJun 20, 2024 · Weight Variation Hardness Variation Aging of tablets/ Loss of hardness Protracted Hardness (Hardness increases with time) Disintegration time too long Uneven Breakage Black Spot/Stain Double Impression Bisected/ Score line/ breakline or imprint or logo not sharp or well-defined Splitting of Layered tablets or layer separation dick\\u0027s sporting goods oxford ms