刘茜; 马强; 席海为; 王烨; 白桦; 王超
建立了测定化妆品中三氯叔丁醇的气相色谱-质谱分析方法.膏霜、水剂、散粉、香波、唇膏等不同类型的化妆品样品加入50％甲醇-无水乙醇或无水乙醇超声提取后,样品提取液高速离心处理,取上清液经无水硫酸钠脱水,进行气相色谱-质谱定性及定量分析.选用DB-1701(30 m×0.25 mm×0.25μm)石英毛细管柱,程序升温,流速1.0 mL/min,采用电子轰击电离源,选择监测离子(m/z 53、59、125,其中59为定量离子),外标法定量.方法的平均回收率为83.4％～107.6％,相时标准偏差(RSD)为1.0％ ～5.3％,膏霜、水剂、散粉、香波、唇膏等不同类型化妆品中二氯叔丁醇的检出限均为0.8 mg/kg.%A gas chromatography-mass spectrometric method was developed for the determination of chlorobutanol in cosmetic samples. Hie cream, lotion, powder, shampoo and lipstick samples were ultrasonically extracted with 50% methanol-ethanol or ethanol, and then centrifuged. The eluent was further dehydrated and then analyzed with a capillary column ( DB-1701, 30 m × 0.25 mm × 0.25 jjun) under electron ionization conditions at a flow rate of 1. 0 mL/min. The quantitation was performed by the external standard method under selected ion monitoring mode (SIM) using monitoring ions of m/z 53, 59, 125. The recoveries were 83. 4% ～ 107.6% , with the relative standard deviations (RSDs) of 1.0% ～5. 3%. All the detection limit of cream, lotion, powder, shampoo and lipstick samples was 0. 8 mg/kg. This method was proved to be simple, accurate, and stable by testing experiments, which was suitable for the detection of chlorobutanol in cosmetics.
...), published in the Federal Register of April 9, 1971 (36 FR 6842). (iv) Sulfo-Van Ointment (DESI 2230... identical, similar and related products (21 CFR 310.6). Deferral of requirements is not appropriate for the..., chlorobutanol, phenol, camphor, alum, and isopropyl alcohol. (b) Zirnox Topical Lotion,...
Hutchings, Regina L; Singh, Surinder M; Cabello-Villegas, Javier; Mallela, Krishna M G
One-third of protein formulations are multi-dose. These require antimicrobial preservatives (APs); however, some APs have been shown to cause protein aggregation. Our previous work on a model protein cytochrome c indicated that partial protein unfolding, rather than complete unfolding, triggers aggregation. Here, we examined the relative strength of five commonly used APs on such unfolding and aggregation, and explored whether stabilizing the aggregation 'hot-spot' reduces such aggregation. All APs induced protein aggregation in the order m-cresol > phenol > benzyl alcohol > phenoxyethanol > chlorobutanol. All these enhanced the partial protein unfolding that includes a local region which was predicted to be the aggregation 'hot-spot'. The extent of destabilization correlated with the extent of aggregation. Further, we show that stabilizing the 'hot-spot' reduces aggregation induced by all five APs. These results indicate that m-cresol causes the most protein aggregation, whereas chlorobutanol causes the least protein aggregation. The same protein region acts as the 'hot-spot' for aggregation induced by different APs, implying that developing strategies to prevent protein aggregation induced by one AP will also work for others.
Kaur, Indu Pal; Lal, Shruti; Rana, Cheena; Kakkar, Shilpa; Singh, Harinder
Presence of a preservative in an ocular medication has often been considered a culprit in damaging the epithelium. However, the inclusion of a preservative is equally necessary, especially in multiple-dose containers, in order to protect against dangerous organisms accidentally gaining access during instillation. Benzalkonium chloride (BAK), chlorobutanol, chlorhexidine acetate (CHA), and phenylmercuric nitrate or acetate are some commonly used preservatives in eye preparations. New preservatives with a wide range of activity and good safety profiles have been introduced in the market, such as stabilized oxychloro complex (SOC), sofZia, and sodium perborate. In the present review, we discuss various conventional and newly proposed and patented preservative molecules for ocular use. Reasons for discontinuing traditional preservatives and the need for less-toxic molecules are discussed at length, along with newer options coming up in this area.
The paper deals with some studies carried out to evaluate the feasibility of radiation sterilization or treatment of some medical products and pharmaceuticals of immediate importance to their respective industries. The products include penicillin G sodium, ampicillin sodium, tetracyclin hydrochloride ointment,hydrocortisone acetate and its ointment, aqueous sodium chloride solutions (0.9 and 20%), fluorescein sodium strips, urea, ethylmorphine hydrochloride, aqueous solution of chlorobutanol and one of its commercial preparations, phenylmercuric nitrate and its aqueous solutions, aqueous solutions of methyl and propyl paraben, lactose, gum karaya, absorbent cotton and poly-(vinyl chloride) based medical products. The irradiated products have been examined for pharmacopoeial specifications wherever available. In general the products have been examined for changes in colour, pH, ultra-violet and infra-red absorption spectra. Thin-layer chromatographic analyses have been carried out to establish the purity of some of the irradiated products. The feasibility or otherwise of radiation sterilization or treatment of the various products from the physicochemical and microbiological (pharmacological) clinical considerations is also described. (author)