IndraLab

Statements

NPPA binds USP37. 17 / 17
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"This approach is commonly used to compare the performance of two products ( USP37-NF32, 2014 )."
25448554
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"Distinct testing devices are described under USP chapter <1724> ( USP37-NF32, 2014a ), representing either self-standing apparatus (vertical diffusion cells) or adaptions to the standard dissolution e[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
27208656
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"Functionality is a broad, qualitative, and descriptive term for the general purpose or role an excipient serves in a formulation ( Sheehan, 2011; USP37-NF32, 2014a )."
24993785
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"Given that in vitro release tests with synthetic membranes do not directly measure drug bioavailability ( USP37-NF32, 2014c ), this finding confirmed that enhancer cells are equally suitable for detec[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
28602800
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"Moreover, although not a direct indication of drug bioavailability ( USP37-NF32, 2014c ), in vitro release data can provide useful information on the role of various factors, such as solubility of ACF[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
28602800
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"Topical drug products include semi-solid dosage forms such as creams, ointments, lotions and gels ( USP37-NF32, 2014b )."
27208656
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"Diluents are incorporated into tablet or capsule dosage forms to increase dosage form volume or weight, and as such they can also be referred to as fillers ( USP37-NF32, 2014a )."
24993785
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"According to the US Pharmacopeia (USP), the limit of these heavy metal content in drugs and dietary supplements is defined as the oral permitted daily exposure (PDE) for: Cd 25 μg/day, Pb 5 μg/day, an[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
27283634
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"Although the compaction properties of tablet diluents are considered as relevant, and guidelines can be found to assess tablet strength ( Podczeck, 2012; USP37-NF32, 2014b ), no recommendations are cu[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
24993785
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"However, other methods are also described ( USP37-NF32, 2014 )."
26070249
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"In vitro non-similarity could be a signal of altered in vivo performance ( SUPAC-SS, 1997; USP37-NF32, 2014 )."
26070249
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"TCS classification can also be applicable to other topical dosage forms such as ophthalmic, for which a new compendial chapter <1771> has been adopted with the same IVR tools ( USP37-NF32, 2014a )."
27208656
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"The non-mandatory USP information chapter on excipient performance lists additional physical properties relevant to tablet diluents, and therefore to MCC, and includes: (1) particle size and size dist[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
24993785
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"An assessment of uniformity of investigated samples regarding the visual uniformity and content uniformity of ACF was carried out according to procedure described in the US Pharmacopoeia (USP) for the[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
28602800
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"The top, middle and bottom portions, when tested for drug content uniformity, showed that all investigated formulations compiled with USP specification ( USP37-NF32, 2014a ), thus clearly indicating t[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
28602800
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"We also determined the total flavonol glycosides in the hydrolyzed samples according to the method described in USP37-NF32."
26907698
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"According to the USP ( USP37-NF32, 2014b ), in the absence of appropriate stability information, extemporaneously prepared, water-containing topical semisolid formulations are assigned beyond-use date[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
28602800