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Effect of microwave radiation on redissolving precipitated matter in fluorouracil injection.

American journal of hospital pharmacy · 1980 · No effect · Low evidence

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No effectLow evidencePaper 6049

Fifteen ampuls with precipitate heated to 60°C in a microwave oven and fifteen heated in a water bath, compared with 15 unheated controls, all met USP concentration requirements with no significant decrease in potency. Microwave-heated ampuls showed a statist…

Study snapshot

PublicationAmerican journal of hospital pharmacy · 1980
Study typeother
Reported directionNo effect
Evidence ratingLow

Abstract

The effect on the stability of fluorouracil injection of using microwave radiation to redissolve precipitated matter was studied. Fifteen ampuls each of Fluorouracil Injection, USP, containing precipitate were heated to 60 degrees C in a microwave oven and water bath, respectively. The contents of each heated ampul and of 15 control ampuls (unheated, no precipitate) were assayed by high-performance liquid chromatography, and the pH value of each sample was measured. Each test group fell within USP concentration requirements and showed no significant decrease in potency. Among the microwave-heated ampuls, a mean drop of 0.03 pH units was significant (p less than 0.05) but did not affect drug stability or solubility, since all samples remained within the USP pH range of 8.6-9.0. Precipitated matter in fluorouracil injection can be redissolved by heating with microwave radiation without significantly affecting the drug's stability.

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AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typeother
Effect directionno_effect
PopulationNot supplied
Sample size45
Exposuremicrowave
Evidence strengthLowConfidence: 78% · Peer reviewed: yes

Main findings

Fifteen ampuls with precipitate heated to 60°C in a microwave oven and fifteen heated in a water bath, compared with 15 unheated controls, all met USP concentration requirements with no significant decrease in potency. Microwave-heated ampuls showed a statistically significant mean pH drop of 0.03 units (p<0.05) but remained within the USP pH range (8.6–9.0) and this did not affect stability or solubility; precipitate could be redissolved using microwave heating without significantly affecting stability.

Outcomes measured

  • fluorouracil injection potency (HPLC assay)
  • pH change
  • drug stability
  • drug solubility/redissolution of precipitate

Limitations

  • Microwave exposure parameters (e.g., frequency, power, duration) not reported in abstract
  • Small sample size (15 ampuls per group)
  • Study assesses pharmaceutical product stability rather than biological/health outcomes
View raw extracted JSON
{
  "study_type": "other",
  "exposure": {
    "band": "microwave",
    "source": "microwave oven",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": null
  },
  "population": null,
  "sample_size": 45,
  "outcomes": [
    "fluorouracil injection potency (HPLC assay)",
    "pH change",
    "drug stability",
    "drug solubility/redissolution of precipitate"
  ],
  "main_findings": "Fifteen ampuls with precipitate heated to 60°C in a microwave oven and fifteen heated in a water bath, compared with 15 unheated controls, all met USP concentration requirements with no significant decrease in potency. Microwave-heated ampuls showed a statistically significant mean pH drop of 0.03 units (p<0.05) but remained within the USP pH range (8.6–9.0) and this did not affect stability or solubility; precipitate could be redissolved using microwave heating without significantly affecting stability.",
  "effect_direction": "no_effect",
  "limitations": [
    "Microwave exposure parameters (e.g., frequency, power, duration) not reported in abstract",
    "Small sample size (15 ampuls per group)",
    "Study assesses pharmaceutical product stability rather than biological/health outcomes"
  ],
  "evidence_strength": "low",
  "confidence": 0.78,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "microwave radiation",
    "microwave oven",
    "fluorouracil injection",
    "precipitate",
    "redissolution",
    "stability",
    "potency",
    "pH",
    "HPLC",
    "USP"
  ],
  "suggested_hubs": []
}
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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: Not supplied
PubMed: 7386478

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