[Commission on "Reference Standards". The concept of reference standards in clinical biology (Document A, Part 3)].
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Chemistry, Clinical↗
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[d-Camphor Reference Standard (Control 901) and dl-Camphor Reference Standard (Control 901) of National Institute of Hygienic Sciences].
The raw materials of d-camphor and dl-camphor were examined for the preparation of the "d-Camphor Reference Standard" and "dl-Camphor Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 257 nm; absorbance, E1%1cm(257 nm) = 723; infrared spectrum, 2956, 1742, 1045 cm-1; optical rotation, [alpha]20D = +42.9 degrees (d-camphor), [alpha]20D = -0.00 degrees (dl-camphor); melting point, 180 degrees C (d-camphor), 179 degrees C (dl-camphor); gas-chromatography, one impurity was detected in d-camphor and four impurities were detected in dl-camphor. Based on the above results, these raw materials were authorized to be the Reference Standards of the National Institute of Hygienic Sciences.
Camphor↗
[d-Camphor reference standard (Control 911) and dl-Camphor Reference Standard (Control 911) of the National Institute of Hygienic Sciences].
The raw materials of d-camphor and dl-camphor were examined for preparation of the "d-Camphor Reference Standard" and "dl-Camphor Reference Standard". Analytical data obtained were as follows: ultraviolet spectrum, lambda max = 290nm; infrared spectrum, 2958, 1742, 1045cm-1; optical rotation, [alpha]D20 = +42.7 degrees (d-camphor), [alpha]D20 = -0.3 degrees (dl-camphor); melting point, 180 degrees C (d-camphor), 179 degrees C (dl-camphor); gas-chromatography (GC), one impurity was detected in d-camphor and three impurities in dl-camphor; assay, 99.5% (d-camphor), 99.5% (dl-camphor) by GC. Based on the above results, these raw materials were authorized as the Japanese Pharmacopoeia Standard (Control 911).
Camphor↗
[Retinol Acetate Reference Standard for Thin-layer Chromatography (Control 901) and Retinol Palmitate Reference Standard for Thin-layer Chromatography (Control 901) of National Institute of Hygienic Sciences].
The raw materials of retinol acetate and retinol palmitate were examined for the preparation of the "Retinol Acetate Reference Standard for Thin-layer Chromatography" and "Retinol Palmitate Reference Standard for Thin-layer Chromatography", respectively. Analytical data obtained were as follows: thin-layer chromatography, no impurities were detected in retinol acetate and one impurities was detected in retinol palmitate; The Rf values of retinol acetate and retinol palmitate were consistent with those of Reference Standards (Control 713), respectively; ultraviolet spectrum, lambda max = 326 approximately 327 nm; relative extinction, within the range reported in JPXI; weight variation of capsules, retinol acetate 224.0 +/- 15.5 mg (RSD 6.9%), retinol palmitate 222.0 +/- 13.8 mg (RSD 6.2%); assay, retinol acetate 57000 I.U./g, retinol palmitate 57000 I.U./g. Based on the above results, these raw materials were authorized to be the Reference Standards of the National Institute of Hygienic Sciences.
Chromatography, Thin Layer↗
[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0201)].
To establish the third lot (Control 0201) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 130 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the third lot of the Endotoxin 100 Reference Standard containing 130 EU of endotoxin per vial.
Endotoxins↗
[The Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard) (Control 0211)].
To establish the fifth lot (Control 0211) of the Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined a s containing approximately 16,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fifth lot of the Endotoxin 10000 Reference Standard containing 16,000 EU per vial.
Endotoxins↗
[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0101)].
To establish the second lot (Control 0101) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 100 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the second lot of the Endotoxin 100 Reference Standard containing 100 EU of endotoxin per vial.
Endotoxins↗
[The Endotoxin Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin Reference Standard) (Control 971)].
The third lot (Control 971) of the Endotoxin Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin Reference Standard) was prepared. The potency of the new lot was assayed against USP Endotoxin Reference Standard (EC-6) and defined as containing 13,000 endotoxin units (EU) per vial by a collaborative study of 7 laboratories.
Endotoxins↗
[The Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard) (Control 0001)].
To establish the fourth lot (Control 0001) of the Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 20,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fourth lot of the Endotoxin 10,000 Reference Standard containing 20,000 EU per vial.
Endotoxins↗
[Studies on the identification of psychotropic substances (VII). Preparation and various analytical data of standard references of some hallucinogens, 3,4-methylenedioxyamphetamine (MDA), 3,4- methylenedioxymethamphetamine (MDMA) and 5-methoxy-3,4- methylenedioxyamphetamine (MMDA)].
The Reference Standards of 3, 4-methylenedioxyamphetamine (MDA), 3, 4-methylenedioxymethamphetamine (MDMA) and 5-methoxy-3,4-methylenedioxyamphetamine (MMDA) were prepared. Their purities determined by HPLC were 99.8% for DMA hydrochloride, 99.8% for MDMA hydrochloride and 99.5% for MMDA hydrochloride. For the identification and determination, various analytical data of the three drugs were measured and studied by TLC, UV, IR, HPLC, GC/MS and NMR.
3,4-Methylenedioxyamphetamine↗
Determination of polybrominated diphenyl ethers in environmental standard reference materials.
Standard reference materials (SRMs) are valuable tools in developing and validating analytical methods to improve quality assurance standards. The National Institute of Standards and Technology (NIST) has a long history of providing environmental SRMs with certified concentrations of organic and inorganic contaminants. Here we report on new certified and reference concentrations for 27 polybrominated diphenyl ether (PBDE) congeners in seven different SRMs: cod-liver oil, whale blubber, fish tissue (two materials), mussel tissue and sediment (two materials). PBDEs were measured in these SRMs, with the lowest concentrations measured in mussel tissue (SRM 1974b) and the highest in sediment collected from the New York/New Jersey Waterway (SRM 1944). Comparing the relative PBDE congener concentrations within the samples, we found the biota SRMs contained primarily tetrabrominated and pentabrominated diphenyl ethers, whereas the sediment SRMs contained primarily decabromodiphenyl ether (BDE 209). The cod-liver oil (SRM 1588b) and whale blubber (SRM 1945) materials were also found to contain measurable concentrations of two methoxylated PBDEs (MeO-BDEs). Certified and reference concentrations are reported for 12 PBDE congeners measured in the biota SRMs and reference values are available for two MeO-BDEs. Results from a sediment interlaboratory comparison PBDE exercise are available for the two sediment SRMs (1941b and 1944).
Journal Article↗
Assay and purity evaluation of sunepitron hydrochloride by reversed-phase liquid chromatography using a reference standard composite.
A reference standard composite was prepared that contained the active pharmaceutical ingredient sunepitron and three potential impurities. This standard was characterized and used for concomitant quantitation of sunepitron and its potential impurities in samples of drug substance and drug product. This approach minimizes the number and quantity of reference standards which often are expensive to synthesize, characterize, and maintain. In addition, running assays becomes simpler because the number of reference standard solutions required for each assay is reduced. Reference standard composites can also be used for qualitative applications such as demonstrating system suitability or for retention times markers for process related impurities or degradants.
Bridged Bicyclo Compounds, Heterocyclic↗
[On the National Institute of Hygienic Sciences standard (the Japanese Pharmacopoeia standard) "Ergometrine Maleate Reference Standard (control 751)" (author's transl)].
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Chemical Phenomena↗
[On the National Institute of Hygienic Sciences standard (Japanese Pharmacopoeia standard) "Cortisone Acetate Reference Standard (control 741)" (author's transl)].
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Chemical Phenomena↗
Assignment of Neisseria meningitidis serogroup A and C class-specific anticapsular antibody concentrations to the new standard reference serum CDC1992.
A new standard meningococcal reference serum designated CDC1992 was prepared to replace meningococcal reference sera ECG and PB-2, which are not available in sufficient quantities for continued use as primary reference sera. CDC1992 was prepared from 14 healthy adult volunteers who underwent plasmapheresis 4 to 12 weeks postvaccination with a single dose of a Neisseria meningitidis quadrivalent polysaccharide vaccine. Total and/or class-specific meningococcal serogroup A and C anticapsular antibody concentrations (in micrograms per milliliter) were assigned to CDC1992 by using homologous and heterologous enzyme-linked immunosorbent assay (ELISA) formats. The reference serum ECG was used as a reference standard to assign total anticapsular antibody concentrations to CDC1992 by a homologous ELISA format. A heterologous ELISA format, with the Haemophilus influenzae type b standard reference serum FDA 1983, was used to assign total and class-specific antibody concentrations to CDC1992. Alkaline phosphatase-labeled mouse anti-human monoclonal antibody conjugates were used as secondary antibodies in both ELISA formats. The total, immunoglobulin G (IgG), IgA, and IgM antibody concentrations, assigned to CDC1992 for serogroup A were 135.8, 91.8, 20.1, and 23.9 micrograms/ml, respectively, and those for serogroup C were 32.0, 24.1, 5.9, and 2.0 micrograms/ml, respectively. Meningococcal serogroup A and C antibody concentrations were in good agreement when homologous and heterologous ELISA format results were compared. Total and class-specific serogroup A and C antibody concentrations were determined in six adult quality control serum samples from the Centers for Disease Control and Prevention by using the homologous ELISA and our assigned antibody concentrations for CDC1992. Antibody concentrations in reference sera ECG and PB-2 were measured in order to provide a historical link to previous studies. The general acceptance of CDC1992 as the standard reference serum and the assigned antibody concentrations will allow investigators to compare antibody levels in serum to those in a single reference preparation.
Adult↗
Similar cellular effects induced by diesel exhaust particles from a representative diesel vehicle recovered from filters and Standard Reference Material 1650.
Standard reference diesel exhaust particles (DEP) SRM 1650 are often used to evaluate the toxicity of DEP. However, these particles did not necessarily reflect the effects of DEP representative of present diesel automobiles. This study was designed to compare the effects of SRM 1650 to DEP from representative cars (RC-DEP) on airway epithelial cells. Therefore we established a method to recover RC-DEP impacted on filters after emission from diesel automobiles on test beds. Electron microscopy and flow cytometry showed that these two types of particles were phagocytosed to the same extent by epithelial cells. This phagocytosis is not dependent on the adsorbed organic compounds in contrast to the cytotoxic effect evaluated by measurements of LDH release. This is emphasized by the fact that RC-DEP equipped with an oxidation catalyst are less cytotoxic than particles from a non-equipped vehicle or SRM 1650. This type of catalyst also reduces significantly the release of GM-CSF by bronchial epithelial cells. We have shown in the present paper that SRM 1650 may be used as a surrogate of DEP. However, exhaust gas post-treatment devices of current diesel automobiles reduce the cytotoxicity as well as the inflammatory response of these particles.
Air Pollutants↗
Certification of polychlorinated biphenyl congeners and chlorinated pesticides in a whale blubber standard Reference Material.
A Standard Reference Material (SRM) made from whale blubber has been developed for the validation of methods used for the determination of polychlorinated biphenyl (PCB) congeners and chlorinated pesticides. This material, which is a frozen blubber tissue homogenate, was analyzed using three different analytical techniques. These techniques were based on gas chromatography with electron capture detection on two stationary phases with different selectivity for the separation of PCB congeners and gas chromatography with mass spectrometric detection. The results from these three techniques were in good agreement and were combined to provide certified concentrations for 27 PCB congeners and 15 chlorinated pesticides.
Animals↗
[On the National Institute of Hygienic Sciences standard, "folic acid reference standard"].
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Chromatography, Thin Layer↗