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Record W4401792258 · doi:10.53555/sfs.v10i1.2966

Nitrosamine Impurities In Pharmaceuticals: A Comprehensive Review

2023· review· en· W4401792258 on OpenAlex
Abhas Pandey

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

venuePublished in a venue whose home country is Canada.
no affNo Canadian affiliation: this work is invisible to an affiliation-only frame.
No Canadian affiliation. An affiliation-only frame, the usual design, would never have seen this work. It is one of the works that make the case for inverting the frame.

Bibliographic record

VenueJournal of Survey in Fisheries Sciences · 2023
Typereview
Languageen
FieldChemistry
TopicAnalytical Methods in Pharmaceuticals
Canadian institutionsnot available
Fundersnot available
KeywordsNitrosamineChemistryImpurityEnvironmental chemistryBiochemical engineeringEnvironmental scienceOrganic chemistryCarcinogenEngineering

Abstract

fetched live from OpenAlex

When several nitrosamine impurities are found and their cumulative amount surpasses 26.5 ng/day (which is the maximum daily dose (MDD) allowable consumption for the nitrosamine), the FDA asks the producers to get in touch with them so they may conduct an assessment. When evaluating the risk of human cancer, controlling potentially mutagenic contaminants in pharmaceutical products and crucial interest in the mutagenic and carcinogenic potential of nitrosamine impurities has grown since they were recently found in several medicinal products that are commercialized. A "Cohort of Concern" for which the chemical class is deemed to belong indicates that some common control procedures, including using the threshold of toxicological concern (TTC), cannot be used. These contaminants were in the pharmaceutical products throughout the production process via raw materials, catalysts, and solvents. By altering the production process or taking safety measures while producing drug products, nitrosamine impurities can be prevented. To identify and characterize these contaminants validated analytical methods are applied. Mass spectrometry, liquid chromatography, and gas chromatography are the analytical techniques. These impurities originated from the first time a nitrosating agent was used in secondary, tertiary, and ammonium salt. These techniques aid in maintaining a low concentration of nitrosamine contaminants in a drug or drug product intended for use in human medicine.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.011
metaresearch head score (Gemma)0.010
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.864
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0110.010
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0040.001
Bibliometrics0.0010.003
Science and technology studies0.0000.002
Scholarly communication0.0000.000
Open science0.0020.000
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.732
GPT teacher head0.525
Teacher spread0.207 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it