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At least 235 records · Page 13Linked to original sources

[Glycyrrhizinic Acid Reference Standard (Control 031) of National Institute of Health Sciences].

The raw material of glycyrrhizinic acid was examined for preparation of the "Glycyrrhizinic Acid Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 251 nm; and specific absorbance (E(1 cm)1%) in ethanol at 251 nm, 146.4; IR spectrum, specific absorptions of raw material were consistent with those of Standard (Control 0221). Also, thin-layer chromatography, no impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.2% and total amount of impurities was less than 0.2%. Based on the above results, the candidate material was authorized as the Glycyrrhizinic Acid Reference Standard (Control 031) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗

[Glycyrrhizinic Acid Reference Standard (Control 001) of National Institute of Health Sciences].

The raw material of glycyrrhizinic acid was examined for preparation of the "Glycyrrhizinic Acid Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 251 nm; and specific absorbance (E1ca1%) in ethanol at 251 nm, 146; IR spectrum, specific absorptions at 1714, 1655, 1215, and 1170 cm-1; and the spectrum of raw material was consistent with that of Standard (Control 991). Also, thin-layer chromatography, no impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.2% and total amount of impurities was less than 0.4%. Based on the above results, the candidate material was authorized as the Glycyrrhizinic Acid Reference Standard (Control 001) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗

[Berberine Hydrochloride Reference Standard (Control 001) of National Institute of Health Sciences].

The raw material of Berberine Hydrochloride was examined for preparation of the "Berberine Hydrochloride Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 420, 345, 263 and 228 nm and specific absorbance (E1ca1%) in ethanol at each lambda max, 155, 724, 796 and 820, respectively; IR spectrum, specific absorptions at 2844, 1635, 1569, and 1506 cm-1; and the spectrum of raw material was consistent with that of Standard (Control 941). Also, thin-layer chromatography, an impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.1% and the total amount of impurities was less than 0.2%. Based on the above results, the candidate material was authorized as the Berberine Hydrochloride Reference Standard (Control 001) of the National Institute of Health Sciences.

Berberine↗

[Thiamine Hydrochloride Solution Reference Standard (Control 991) of National Institute of Health Sciences].

The raw material of thiamine hydrochloride solution was examined for preparation of the "Thiamine Hydrochloride Solution Reference Standard (Control 991)". The analytical data obtained were: assay by HPLC, 101.0%; spectrophotometric assay, 100.4%. Based on the above results, the raw material was authorized as the Thiamine Hydrochloride Solution Reference Standard (Control 991) of the National Institute of Health Sciences.

Government Agencies↗

Quality assurance of reference standards from nine European solar-ultraviolet monitoring laboratories.

A program for quality assurance of reference standards has been initiated among nine solar-UV monitoring laboratories. By means of a traveling lamp package that comprises several 1000-W ANSI code DXW-type quartz-halogen lamps, a 0.1-ohm shunt, and a 6-1/2 digit voltmeter, the irradiance scales used by the nine laboratories were compared with one another; a relative uncertainty of 1.2% was found. The comparison of 15 reference standards yielded differences of as much as 9%; the average difference was less than 3%.

Journal Article↗

[Estrone Reference Standard (Control 021) of National Institute of Health Sciences].

The raw material of estrone acetate was examined for the preparation of the "Estrone Reference Standard (Control 021)", The analytical data obtained were: UV spectrum, lambda max of 281 nm and specific absorbance in ethanol at 281 nm = 76.1; Melting point, 261.6 degrees C; IR spectrum, exhibited the specific absorptions at 3345, 2867, 1720, 1499 and 1055 cm-1; thin-layer chromatography, 2 impurities were detected at 100 and 200 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.3%. Based on the above results, the raw material was authorized as Estrone Reference Standard (Control 021) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗

Revalidation and long-term stability of National Institute of Standards and Technology Standard Reference Materials 1566, 1567, 1568, and 1570.

Multiple units of Standard Reference Materials (SRMs) 1566 Oyster Tissue, 1567 Wheat Flour, 1568 Rice Flour, and 1570 Trace Elements in Spinach, produced by the National Institute of Standards and Technology (NIST, then the National Bureau of Standards), were analyzed 17-20 years after the original certification dates and 12-15 years after the certificates became invalid. Instrumental neutron activation analysis and thermal neutron prompt gamma-ray activation analysis were used to measure mass fractions for 27 elements in these SRMs to revalidate them for use in quality assurance (QA) programs required for food analysis programs within the U.S. Food and Drug Administration. With the exception of Se in SRM 1567, all element mass fractions were in agreement with certified values and literature data. Some evidence of B loss from SRM 1568 was observed. These materials were judged to be suitable for continued use in QA programs. Findings showed that these matrixes exhibited stability of moisture, mass fraction, and weight basis for far longer (> or =15 years) than was indicated by the 5-year validity statement on the NIST Certificates of Analysis.

Animals↗

[Hydrocortisone Acetate Reference Standard (Control 961) of National Institute of Health Sciences].

The raw material of hydrocortisone acetate was tested for the preparation of the "Hydrocortisone Acetate Reference Standard (Control 961)". Analytical data obtained were as follows: IR spectrum, specific absorption wave numbers at 3428, 1748, 1723, 1631, and 1375 cm-1; specific absorbance, E1cm1% (242 nm) = 406; thin-layer chromatography, no impurities were detected until 0.05 microgram; high-performance liquid chromatography (HPLC), 2-3 impurities were detected and the amount of the total impurities was estimated to be about 0.2%; assay by HPLC, 100.7%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Reference Standard (Control 961).

Hydrocortisone↗

Determination of ephedrine alkaloids in dietary supplement standard reference materials.

A suite of five ephedra-containing dietary supplement Standard Reference Materials (SRMs) has been issued by the National Institute of Standards and Technology (NIST) with certified values for ephedrine alkaloids, synephrine, caffeine, and selected toxic trace elements. The materials represent a variety of natural, extracted, and processed sample matrixes that provide different analytical challenges. The constituents have been determined by multiple independent methods with measurements performed by NIST and by three collaborating laboratories. The methods utilized different sample extraction and cleanup steps in addition to different instrumental analytical techniques and approaches to quantification. In addition, food-matrix proximates were determined by National Food Processor Association laboratories for one of the ephedra-containing SRMs. The SRMs are primarily intended for method validation and for use as control materials to support the analysis of dietary supplements and related botanical materials.

Alkaloids↗

[Thiamine Hydrochloride Solution Reference Standard (Control 971) of National Institute of Health Sciences].

The raw material of thiamine hydrochloride solution was examined for the preparation of the "Thiamine Hydrochloride Solution Reference Standard (Control 971)". Analytical data obtained were as follows: assay by HPLC, 100.8%; spectrophotometric assay, 99.8%. Based on the above results, the raw material was authorized to be the Thiamine Hydrochloride Solution Reference Standard of the National Institute of Health Sciences.

Government Agencies↗

[Prednisolone reference standard (Control 911) of the National Institute of Hygienic Sciences].

Prednisolone was tested for preparation of the "Prednisolone Reference Standard (Control 911)". The quality of raw material was examined and compared with the previous Reference Standard (Control 872). Analytical data obtained were as follows: loss on drying, 0.10%; melting point, 233.2 degrees C (decomposition); optical rotation, [alpha]20D+98.77 degrees; UV spectrum, lambda max = 243nm; absorptivity, E1%1cm (243nm) = 413.5; IR spectrum, 1711, 1612, 1110, 888cm-1; one impurity was detected by thin-layer chromatography and high-performance liquid chromatography (HPLC), respectively; assay, 100.1% by HPLC. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Standard (Control 911).

Chromatography, Thin Layer↗

[Glycyrrhizinic Acid Reference Standard (Control 0211 and 0221) of National Institute of Health Sciences].

The raw material of glycyrrhizinic acid was examined for preparation of the "Glycyrrhizinic Acid Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 251 nm; and specific absorbance (E1% 1 cm) in ethanol at 251 nm, 149.6 (Control 0211) and 145.7 (Control 0221); IR spectrum, specific absorptions of raw material were consistent with that of Standard (Control 001). Also, thin-layer chromatography, no impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.2% and total amount of impurities was less than 0.6%. Based on the above results, the candidate materials were authorized as the Glycyrrhizinic Acid Reference Standard (Control 0211 and 0221) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗

Deletions below 10 megabasepairs are detected in comparative genomic hybridization by standard reference intervals.

Comparative genomic hybridization (CGH) is a widely used technique for studying chromosomal imbalances. The sensitivity of the technique is, however, relatively low. Deletions down to a size of 10-12 Mbp have been detected by the use of fixed diagnostic thresholds. In this study, we applied standard reference intervals as detection criteria on a number of deletions in the range of 3 Mbp to 14-18 Mbp. All deletions were detected. Thus, detection by standard reference intervals confers a considerably higher sensitivity to CGH analysis compared to fixed diagnostic thresholds. Genes Chromosomes Cancer 25:410-413, 1999.

Chromosome Aberrations↗

A human mitochondrial DNA standard reference material for quality control in forensic identification, medical diagnosis, and mutation detection.

A human mitochondrial DNA (mtDNA) standard reference material (SRM 2392) will provide quality control when mtDNA is sequenced for forensic identifications, medical diagnosis, or mutation detection. SRM 2392 includes DNA from two lymphoblast cell cultures (CHR and 9947A) and cloned DNA from the CHR HV1 region, which contains a C stretch and is difficult to sequence. The mtDNA sequence (but not the DNA) of a third human template GM03798 is provided for comparison. Fifty-eight unique primer sets allow any area or the entire mtDNA (16,569 bp) to be amplified and sequenced. While none of the differences in these three templates correspond to published mutations associated with specific diseases, some of these differences did result in animo acid changes compared with that published by S. Anderson et al. (1981, Nature 290: 457-465). An interlaboratory evaluation of the amplification, sequencing, and data analysis of the CHR template was conducted by four laboratories. Corroboration of the SRM results will provide quality assurance that any unknown mtDNA is also being amplified and sequenced correctly.

Cell Line↗

Creating an altitude-adjusted hematocrit reference standard for adults 18-40 years of age in China.

This study was conducted to provide a scientific basis for development of a unified hematocrit reference standard for young adults (i.e., 18-40 yr of age) in China. Hematocrit values for healthy young adults (n = 34,383 men and 24,040 women) were collected in accordance with the Wintrobe method. The author used correlation and regression analyses to investigate the relationship between hematocrit values and altitude. Hematocrit values increased gradually with altitude, and the relationship was statistically significant (p < 0.01). It was determined that regression equations could be used to calculate hematocrit reference standards for healthy male and female adults in the aforementioned age group, provided that the mean altitude of a region was used in the analysis. The author offers examples that represent 3 regions of China characterized by different mean altitudes: (1) Qingzang District (4,000-m altitude), Central District (2,000-1,000 m), and Eastern District (< 500 m).

Adolescent↗

[Cholecalciferol Reference Standard (Control 871) of National Institute of Hygienic Sciences].

Cholecalciferol Reference Standard (Control 871) for the Japanese Pharmacopoeia was prepared. The following analytical data were obtained: melting point, 86.3 degrees C; infrared spectrum, same as the Japanese Pharmacopoeia Standard "Cholecalciferol Standard (Control 851)"; absorbance, E1%1cm (265 nm) = 474.5; optical rotation, [alpha]20D = + 110.0 degrees; thinlayer chromatography, same as the Japanese Pharmacopoeia Standard; highperformance liquid chromatography, contaminants were not detected; assay, 100.7%. On the basis of those results, this material was authorized as the Japanese Pharmacopoeia Standard (control 871).

Chemical Phenomena↗

Renewable standard reference material for the detection of TP53 mutations.

BACKGROUND: Numerous DNA-based tests are currently in use or under development for the detection of mutations associated with disease. Most of the current methods use PCR amplification technologies and detection after separation or chromatography of the products. We have developed a panel of standard reference materials consisting of 12 plasmid clones containing a 2.0 kb region of the TP53 gene, including exons 5-9. Eleven of these clones contain a single mutation within the mutational hot spots of the TP53 gene, the twelfth is wild-type in this region of the gene. The mutations are amino acid (aa) 128: C to T; aa 175: G to A; aa 237: T to C; aa 245: G to A; aa 248: C to T; aa 248: G to A; aa 249: G to T; aa 273: C to T; aa 273: G to A; aa 282: C to T; and aa 328: T to C. These standard reference materials (SRMs), created by site-directed mutagenesis of wild-type TP53 from a human cell line, include the specific mutations most commonly found to be associated with cancer. Their use will improve disease detection by serving as validation materials to monitor errors in measurement methods, including PCR amplification, amplicon separation, and data analysis from different technology platforms. METHODS AND RESULTS: The single point mutations of the panel were validated by capillary electrophoresis single-strand conformational polymorphism analysis, denaturing gradient gel electrophoresis, and denaturing high-performance liquid chromatography, as well as full sequence analysis of both DNA strands of the cloned material. For both heteroduplex analysis methods, the presence of the mutations was resolved for each SRM. CONCLUSION: The generation of a standard TP53 reference panel and demonstration that the panel can successfully validate mutation detection across different mutation scanning technology platforms. Hence, this panel functions as an SRM to normalize results obtained from different laboratories using different techniques.

Base Sequence↗

[Tocopherol Succinate Reference Standard (Control 881) of National Institute of Hygienic Sciences].

Tocopherol succinate was tested for the preparation of "Tocopherol Succinate Reference Standard (Control 881)". Analytical data obtained were as follows: infrared spectrum, same as Tocopherol Succinate Reference Standard (Control 851); absorbance, E1cm1% (286 nm) = 40.5; thin-layer chromatography, contaminants were not detected until 50 micrograms; high-performance liquid chromatography, three contaminants were detected; loss on drying, 0.09%; assay, 100.0%. On the basis of the above results, this material was authorized as the Japanese Pharmacopoeia Standard (Control 881).

Chromatography, High Pressure Liquid↗