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There is a growing body of evidence showing that there are significant differences between some nanomaterials and their non-nanoscale counterparts. What those differences portend raises many new questions about their potential to cause harm to human health and the environment.
The FDA defines data integrity as "completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)". ALCOA itself has evolved to ALCOA Plus, which incorporates two of the fundamental definition terms as stated by the FDA; complete, consistent, enduring, and available. Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell products into the United States, and also applies to other related industries.
PerkinElmer's UV WinLab™ Enhanced Security (ES) software platform for UV/Visible spectroscopy provides structural requirements and features to assist with the needs for ensuring data integrity and compliance. It affords the system owner the ability to comply with regulations and incorporate features into the validation plan to exhibit compliance. The purpose of this document is to demonstrate how UV WinLab ES meets the technical requirements for 21 CFR Part 11.
The data shows the suitability of the LAMBDA 265 for producing rapid, high-quality spectra. It also shows that the instrument is able to measure the higher nanoparticle sizes, even though these scatter light to a greater extent due to the increased particle size and also settle out more quickly.
In surface waters, phosphorus commonly exists in its phosphate form. A high concentration of phosphate in water is indicative of domestic waste, industrial effluent, and agricultural runoff which can lead to eutrophication. Eutrophication causes an increase in plant and algal growth, which decreases the dissolved oxygen in the water, often leaving the water uninhabitable to organisms. In this application, the quantitative analysis of ortho-phosphate was performed using the LAMBDA 265 UV/Vis spectrophotometer and CHEMetrics ortho-phosphate cell test kit.
Ammonia-nitrogen (NH3-N) occurs naturally in groundwaters at concentrations below 0.2 mg/L and up to 12 mg/L in surface waters, as a result of decomposition of organic matter. High concentrations of ammonia in surface waters are toxic to aquatic life and are indicative of contamination from industrial effluent, raw sewage and agricultural runoff. Ultimately the pH value of the water determines whether ammonia-nitrogen is found as NH4+, NH4OH or NH3. 1 In this application, the quantitative analysis of ammonia-nitrogen was performed using the LAMBDA 265™ UV/Vis spectrophotometer and CHEMetrics ammonia nitrogen cell test.
The efficiency of molecular manipulations involving nucleic acids is heavily dependent on the concentration and purity of the nucleic acid in a sample. The quantification of oligonucleotide is readily accomplished by taking advantage of the absorbance of UV light. Thus, UV light analysis may be used to derive information about the concentration of the sample. This application note describes the quantification of an oligonucleotide using a LAMBDA™ 465 UV/Vis Spectrophotometer.
Principle Total phosphoric compounds in water sample is changed to phosphate (PO4 -) form by oxidation. After treatment with ammonium molybdate • ascorbic acid solution, blue color is created. This color is measured at 880 nm. In this application note, the quantitative analysis of total phosphorus (T-P) was performed by as-corbic acid method. Data are rapidly acquired using LAMBDA™ 465 UV-Vis Spectrophotometer and processed using UV Lab™ Software.
Chromium (VI) ions react with diphenylcarbazide in weakly phosphoric solution. The product, diphenylcarbazone, is a red-violet complex which can be detected photometrically at 550 nm. The chromate cell test kit is suitable for the concentration range of 0.11 – 4.46 mg/L chromate allowing the concentration of chromium(VI) in a water sample to be determined without the use of a calibration curve by multiplying the measured absorbance at 550 nm with a known factor.
Clinical chemistry uses chemical processes to measure levels of chemical components in the blood. It is very useful for the early diagnostic of disease and for monitoring organ function. The most common specimens used in clinical chemistry are blood and urine and this application note shows the common blood tests and measurable items using UV/Vis spectrophotometers as determined by the enzymatic method.
When a water sample containing nitrate ions is treated with brucine in sulfuric acid condition, a yellow compound is created. The quantity of nitrate nitrogen can be determined by measuring the absorbance of the yellow compound at 410 nm. In this application note, the quantitative analysis of Nitrate nitrogen (NO3-N) was performed by Brucine method. Data was rapidly acquired using the LAMBDA™ 465 UV/Vis Spectrophotometer and processed using the UV Lab™ Software.
In this application, the quantitative analysis of formaldehyde was successfully executed using the LAMBDA 265 UV/Vis spectrophotometer and Merck Spectroquant formaldehyde cell test kit. Principle Formaldehyde reacts with chromotropic acid in sulphuric solution to form a violet dye which can be detected photometrically at 565 nm. The formaldehyde cell test kit is appropriate for the concentration range of 0.10 to 8.00 mg/L formaldehyde allowing the concentration of formaldehyde in a water sample to be determined without the use of a calibration curve by multiplying the measured absorbance at 565 nm by a known factor.
Iron is rarely found in its elemental form in nature due to the high tendency of its ions, Fe(II) and Fe(III), to form oxygen and sulphur containing compounds. Concentrations of iron found in surface waters are typically no greater than 1 mg/L, unless contaminated by industrial effluents, whilst much higher concentrations are found in ground waters. The World Health Organization guideline for iron in drinking water is 0.3 mg/L as undesirable bacteria growth in water systems occurs above this concentration. In this application, the quantitative analysis of iron was performed using the LAMBDA 265™ UV/Vis spectrophotometer and CHEMetrics iron cell test kit.