Spectrometric Results of Process Variations in Dacarbazine.

JT Isaacs; PJ Almeter; BS Henderson; AN Hunter; TL Platt; RA Lodder

doi:10.6084/m9.figshare.17868614

Spectrometric Results of Process Variations in Dacarbazine.

JT Isaacs, PJ Almeter, BS Henderson, AN Hunter, TL Platt, RA Lodder

Research output: Contribution to journal › Article › peer-review

Abstract

Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.

Original language	English
Number of pages	9
Journal	Contact in context
Volume	2022
DOIs	https://doi.org/10.6084/m9.figshare.17868614
State	Published - Dec 30 2021

Keywords

drug quality
Pharmaceutical preparations

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10.6084/m9.figshare.17868614

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title = "Spectrometric Results of Process Variations in Dacarbazine.",

abstract = "Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.",

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author = "JT Isaacs and PJ Almeter and BS Henderson and AN Hunter and TL Platt and RA Lodder",

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T1 - Spectrometric Results of Process Variations in Dacarbazine.

AU - Isaacs, JT

AU - Almeter, PJ

AU - Henderson, BS

AU - Hunter, AN

AU - Platt, TL

AU - Lodder, RA

PY - 2021/12/30

Y1 - 2021/12/30

N2 - Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.

AB - Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.

KW - drug quality

KW - Pharmaceutical preparations

U2 - 10.6084/m9.figshare.17868614

DO - 10.6084/m9.figshare.17868614

M3 - Article

C2 - 35035310

SN - 1547-8890

VL - 2022

JO - Contact in context

JF - Contact in context

ER -

Spectrometric Results of Process Variations in Dacarbazine.

Abstract

Keywords

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