Characterization of gamma irradiated petrolatum eye ointment base by headspace-gas chromatography-mass spectrometry.

The effects of gamma irradiation on petrolatum eye ointment base (EOB) and its ingredients (white petrolatum, liquid paraffin, and wool fat) were studied at different irradiation doses. Forty-one volatile radiolysis products were detected and identified by a combined system of headspace-gas chromatography-mass spectrometry (HS-GC-MS). The characteristics of the radiolysis products and the degradation pathway were discussed in each case, respectively. GC method demonstrates that the component distribution patterns of eye ointment as well as its individual ingredients have no differences before and after gamma irradiation. The influence of gamma treatment on EOB was quantitatively determined at 15, 25 and 50 kGy. The concentrations of the radiolysis products increase linearly with increasing doses. Both qualitative and quantitative data show that irradiated eye ointment is safe for human use.

Determination of propionylpromazine hydrochloride in formulation matrixes using reversed-phase ion-pair small bore liquid chromatography.

Propionylpromazine hydrochloride (PPZHCl) has been investigated for use with leghold traps to reduce the amount of self-inflicted trauma experienced by animals restrained by these traps. Three types of PPZHCl formulations made with Karo dark syrup, K-Y Jelly, and Vaseline were used in 2 types of tranquilizer trap devices (TTDs). A reversed-phase ion-pair liquid chromatography (LC) method using a small bore C18 column was used to: (1) determine the purity of the PPZHCl material used in these formulations, and (2) to determine the resulting PPZHCl content of each formulation. Analyte quantitation was done using UV absorption at 280 nm. Regression analysis of calibration standard solutions indicated a linear and directly proportional relationship between analyte response and PPZHCl concentration over the range evaluated. Recovery data from: (1) Vaseline formulations containing 38.8, 16.2, and 8.78% PPZHCl were 104, 92.9, and 90.2%, respectively, (2) Karo dark syrup formulations containing 26.5, 18.1, and 10.3% PPZHCl were 97.7, 99.3, and 106%, respectively, and (3) K-Y Jelly formulations containing 33.0, 23.5, and 13.4% PPZHCl were 100, 99.4, and 88.7%, respectively. The relative standard deviation (RSD) values from triplicate analysis of these formulations ranged from 0.7 to 6.7%. The PPZHCl content from 9 manufactured TTDs, 3 for each formulation type, were analyzed in triplicate and produced RSD values ranging from 0.7-6.8%. These results indicate that the formulation extraction presented could be used to evaluate the PPZHCl content in TTDs prior to field use. The use of a small bore LC column reduced the amount of solvents consumed and hazardous waste generated, compared to sample analysis that uses a more conventional analytical LC column.

Patch test allergens in petrolatum: a reappraisal.

Patch test materials in petrolatum, from 3 different manufacturers and 14 different types were evaluated by gross and microscopic examination. The allergens were noted to be suspended as particles or droplets in the vehicle. Obvious variations in both size and structure of the included allergen were found with the same chemicals but of different manufacture. Several materials do not meet the pharmaceutical standards which should be requested regarding stability, particle size and packing. A more detailed declaration is proposed.

Contact allergy to petrolatums. (II). Attempts to identify the nature of the allergens.

Using several chromatographic and spectrometric procedures, it was established that the allergens present in pharmaceutical and cosmetic petrolatums are probably polycyclic aromatic hydrocarbons. These substances are impurities, and the quantity present is largely a function of the source of the petrolatum and the purification procedures. As the aromatic portion in petrolatum is a very complex and unstable mixture of chemically-related agents, only 2 out of the several possible allergens present could be identified: they were most probably phenanthrene derivatives with molecular weights of 230 and 244.

Contact allergy to petrolatums. (I). Sensitizing capacity of different brands of yellow and white petrolatums.

46 yellow and white petrolatums were screened for their skin sensitizing properties in 3 subjects with known histories of contact sensitivity to yellow petrolatum. Patch testing revealed that all the petrolatums examined contain sensitizing substances in varying amounts. The results were analyzed with regard to origin, color, purification procedures involved in the production of pharmaceutical grade petrolatum, and pharmacopoeial requirements satisfied. Allergenicity correlated positively with these parameters, but only among petrolatums of the same brand. Petrolatum sensitivity may sometimes account for false positive patch test reactions to substances diluted in it. A petrolatum which causes no reaction on healthy skin may cause eczematous reactions on damaged skin.

Infrared spectroscopy for tracing of topically applied ointment vehicles and active substances on healthy skin.

Infrared spectroscopy was used to trace active substances and ointment vehicles applied on the skin. Vaseline and lanoline could be traced after 8 hrs but not olive oil. From the active substances, ethyl-4-amino-benzoate (5 per cent), clioquinol (5 per cent), parabenes (15 per cent), 5,7-dichlor-8-hydroxy-2-methyl-chinolin (5 per cent), balsam of Peru (25 per cent) and pyroleum pini (12 per cent) could be traced 1 hr after application but had disappeared after 8 hrs. Ethylenediamine (1 per cent), chlorcresol (1 per cent), pyroleum lithantracis (5 per cent), were not traceable after 1 hr, and curiously neither neomycine sulphate in spite of its high concentration (20 per cent). The reaction of the skin surface lipids, after application of different substances, was deduced from the spectra. Clioquinol and pyroleum lithantracis seem to give rise to hydrolysis of the triglycerides, the free fatty acids being clearly identifiable. It is felt that infrared spectroscopy can be used as an effective method to trace different substances such as potent allergens on healthy or diseased skin.