IndraLab

Statements

NPPA binds USP43. 17 / 17
| 17
sparser
"USP monograph (USP43–NF38) also touched upon the process of enrichment of deamidated variant >5% by acidic treatment."
33957255
sparser
"The criteria of benzoin from Chinese pharmacopoeia (ChP 2020), USA pharmacopoeia (USP43-NF38), European pharmacopoeia (EP10.0), Japanese pharmacopoeia (JP18) and Indian pharmacopoeia (IP2018) are summarized in xref , in which content determination, ethanol-insoluble matter, acid-insoluble ash, loss on drying, total ash and presence of dammar gum require detailed analysis [ xref , xref , xref , xref , xref ]."
37653893
sparser
"At present, there is no quality control for the polymerized impurities in United States Pharmacopoeia (USP43-NF38) [7] containing mezlocillin sodium, and Japanese Pharmacopoeia (JP17) [8] and Korean P[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
35026591
sparser
"Monographs of all three natural CDs and two of their derivatives can be found in the United States Pharmacopoeia- National Formulary (USP43–NF38) and the European Pharmacopoeia (Pharmacopoeia Europaea[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
33069709
sparser
"In addition, the limit of the number of micro-particles ≥10 and 25 μm in 100-mL filling-volume injections is consistent with those indicated in the pharmacopoeias of all countries, such as USP43–NF38, European Pharmacopoeia 10.0 and Chinese Pharmacopoeia 2020, with limits set as ≤12 and 2 particles/mL."
39170535
sparser
"A standard of upper loss on drying value of 7% is stated in the USP monograph (USP43-NF38)."
34973783
sparser
"USP43-NF38, VP5, and KP12 provided small numbers of stipulations for mineral medicines."
37202592
sparser
"Three syrup bases were used: a sugar-free vehicle for oral solution (according to USP43-NF38), a vehicle with glucose and hydroxypropyl cellulose (according to the DAC/NRF2018) and a commercially available SyrSpend Alka base."
36986577
sparser
"BP6, IP2018, Korean Pharmacopoeia 12th edition (KP12) and United States Pharmacopoeia and National Formulary 2020 (USP43-NF38) provided stipulations of impurities for most of the animal/botanical medicines (95%, 80%, 95%, and 69%, respectively)."
37202592
sparser
"In The United States Pharmacopeia (USP43-NF38) [United States Pharmacopeia Convention, Inc.: Rockville, MD, USA, 2023], the drug is more soluble, and in fact all of the samples can release the dose of the drug within an hour."
39683769
sparser
"Tyloxapol is described as a non-ionic liquid surfactant of the alkyl-aryl-polyether alcohol type in the official monographs of the USP (USP43-NF38, 4551), and is also contained in CA-BRI."
39238043
sparser
"The regulatory bodies have dealt with both the problem of species difference by proposing specific controls for veterinary pharmaceutical forms ( xref ; xref ) and the problem of dosage uniformity linked to the division of the tablets [Uniformity of Dosage Units <905>, USP43-NF38, 2020; Monograph 2.9.40, PhEur 9.1, 2017; Uniformity of Dosage Units 6.02, JP, 2018; ( xref )]."
34722213
sparser
"For information on method development and validation, please refer supplementary material section Covalently linked aggregates of insulin formed because of chemical modification is referred to as High[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
34126389
sparser
"Initially, the HPLC-UV method described in the HU USP monograph (USP43-NF38) was tested for the quantification of HU [ xref ]."
35749410
sparser
"The current assay for Na 2 EDTA injection, according to the United States Pharmacopeia (USP), is based on a titrimetric method that consists of several steps ( USP43-NF38, 2020 )."
33049869
sparser
"According to the USP43-NF38, cyclosporine is practically insoluble in water, with solubility ranging from 6 to 15 µg/mL as deduced from several studies ( Lin et al., 2021 )."
34952149
sparser
"For example, attapulgite (palygorskite) is described by the British Pharmacopeia 2017 (BP2017) as a purified native hydrated “magnesium aluminum silicate” ( British Pharmacopoeia Commission, 2017 ), w[MISSING/INVALID CREDENTIALS: limited to 200 char for Elsevier]"
35952800