Gas Chromatographic Trace Analysis of β-Propiolactone
in Sterilized Serum Proteins

Pruggmayer, D.; Stephan, W.

doi:10.1159/000467314

Cited by 9 publications

(4 citation statements)

References 9 publications

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“…It is thus likely that it will also be effective in inactivating retroviruses associated with AIDS, as well as those associated with T cell leukemia (HTLV-I) [21] and some cases of hairy cell leukemia PPL is a potential carcinogen unless hydrolyzed by plasma hydrolases to the metabolizable non-toxic derivative, P-hydroxypropionic acid [23]. It has been found that the half-life for this transformation is 2% min when PPL is introduced into normal pooled human plasma; thus it is not surprising that the most sensitive gas chromatographic methods have not revealed unhydrolyzed PPL in plasma derivatives exposed to this compound [24]. Furthermore, these derivatives have been found to be non-mutagenic in the Ames test, while the original unhydrolysed compound was strongly mutagenic [25, 261. Thus the frequently expressed fear that PPL-treated plasma derivatives may be carcinogenic appears to be groundless.…”

Section: Discussionmentioning

confidence: 99%

Inactivation of the hutchinson strain of non‐A, non‐B hepatitis virus by combined use of β‐propiolactone and ultraviolet irradiation

Prince

Stephan

Dichtelmüller

et al. 1985

Journal of Medical Virology

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A beta-propiolactone/ultraviolet irradiation procedure (beta PL/UV) has been evaluated for its ability to inactivate 30,000 chimpanzee infectious doses of the Hutchinson strain of non-A, non-B (NANB) virus. The chimpanzees were inoculated with plasma to which this dose of the titrated virus had been added prior to application of the beta PL/UV process in accordance with a procedure used for licensed blood derivatives in Germany. Neither animal developed hepatitis. When subsequently challenged with the same contaminated plasma, which had not been sterilized, both animals promptly developed typical NANB hepatitis. This study extends the high (approximately 10(7)-fold) process efficiency of the beta PL/UV procedure previously reported for hepatitis B virus to a blood-borne NANB virus.

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Section: Discussionmentioning

confidence: 99%

Inactivation of the hutchinson strain of non‐A, non‐B hepatitis virus by combined use of β‐propiolactone and ultraviolet irradiation

Prince

Stephan

Dichtelmüller

et al. 1985

Journal of Medical Virology

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“…It has been reported that there are several analytical methods for the determination of BPL in vaccines, such as high performance liquid chromatography (HPLC) [18], [19] and gas chromatography (GC) [7], [9], [11], [20], [21]. However, due to weak ultraviolet (UV) absorption of BPL [9], it is not advocated to be determined by HPLC with UV-detector.…”

Section: Introductionmentioning

confidence: 99%

Gas chromatography-mass spectrometry method for determination of β-propiolactone in human inactivated rabies vaccine and its hydrolysis analysis

Lei

Gao

Sun³

et al. 2018

Journal of Pharmaceutical Analysis

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A simple method was established for the determination of β-propiolactone (BPL) in human inactivated rabies vaccine by gas chromatography-mass spectrometry (GC-MS). The determination was performed on an Agilent HP-INNOWAX (30 m × 0.32 mm i.d., 0.25 µm) capillary column at the temperature of 80 °C. Electrospray ionization (ESI) was used by selective ion detection at m/z 42. The temperature for ESI source and inlet was set at 230 °C and 200 °C, respectively. Helium was used as the carrier gas at a flow rate of 25.1 mL/min. The total run time was 8 min. Acetonitrile and other components in the sample did not interfere with the determination of BPL. The results showed good linearity of BPL in the range of 0.50–10.01 μg/mL, with the limit of detection and the limit of quantification of 0.015 μg/mL and 0.050 μg/mL, respectively. Satisfactory precision was achieved for the current developed method. The method was applied to detect 6 batches of vaccine samples, and the results indicated that the target analyte BPL was present in three batches of unpurified samples, but was not detected in the purified samples, indicating the test samples were qualified. The established method was proved to be simple, versatile and sensitive, which can meet the requirements of quality control of BPL in human inactivated rabies vaccine.

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“…'-3 Several reports have discussed its chemical activit most notably its behavior as a possible carcinogen. Present analytical methods such as gas chromatography (GC) 6 or colorimetry7 permit the detection of BPL levels to about 1 ~pm. '~' Detection of BPL presents major difficulties.…”

Section: Introductionmentioning

confidence: 99%

Derivatization of β-propiolactone in biological mixtures for enhanced gas chromatographic mass spectrometric determinations

Phillips

Fraser

1981

Biol. Mass Spectrom.

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Detection and identification of low levels (<200 ppb) of free P-propiolactone in complex biological mixtures were achieved through in siru chemical derivatization and subsequent gas chromatographic mass spectrometric determination of the products. P-Propiolactone, when reacted with octadecylamine, followed by trimethylsilylation, yielded a derivative which exhibited both good gas chromatographic characteristics and highly interpretable mass spectrometric data.

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Gas Chromatographic Trace Analysis of β-Propiolactone in Sterilized Serum Proteins

Cited by 9 publications

References 9 publications

Inactivation of the hutchinson strain of non‐A, non‐B hepatitis virus by combined use of β‐propiolactone and ultraviolet irradiation

Inactivation of the hutchinson strain of non‐A, non‐B hepatitis virus by combined use of β‐propiolactone and ultraviolet irradiation

Gas chromatography-mass spectrometry method for determination of β-propiolactone in human inactivated rabies vaccine and its hydrolysis analysis

Derivatization of β-propiolactone in biological mixtures for enhanced gas chromatographic mass spectrometric determinations

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