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PubMed1992

[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↗
PubMed1991

[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↗
PubMed1997

[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↗
PubMed1990

[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↗
PubMed1995

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↗
PubMed1995

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↗
PubMed1985

Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study.

A collaborative study, initiated under the auspices of the Health Industry Manufacturers Association (HIMA), was designed to establish the relationship of Escherichia coli O55:B5 endotoxin (the control standard endotoxin of HIMA and the Food and Drug Administration's Office of Medical Devices) to the U.S. National Reference Standard Endotoxin and to two internationally used control standard endotoxins. By using two Limulus amoebocyte lysate test systems, it was established that the E. coli O55:B5 endotoxin lot originally used by HIMA and the Office of Medical Devices to establish Limulus amoebocyte lysate release test criteria for pyrogen testing of medical devices contains approximately 4.5 endotoxin units (EU) per ng. Thus, the 1.0-ng/kg endotoxin dose limit currently established for medical devices is approximately the same as the 5.0-EU/kg endotoxin limit (on an activity basis) established by several other Food and Drug Administration agencies for human and animal parenteral drugs and biological products.

Endotoxins↗
PubMedDate not supplied

National Bureau of Standards reference materials as organic nutrient standards: a preliminary study.

A preliminary study was conducted to determine if the available National Bureau of Standards (NBS) Standard Reference Materials (SRM) Non-Fat Powdered Milk, Oyster Tissue, Wheat Flour, Rice Flour, Spinach, and Albacore Tuna would be suitable for use as organic nutrient standards. These materials were assayed for folates, total pantothenates, vitamin B6, thiamine, riboflavin, niacin, and protein. Vitamins A, E, D, K, and C were also assayed but, for the most part, were not detected. Based on results from this study, it appears that at least some of the NBS SRMs would be useful as organic nutrient standards.

Animals↗
PubMedDate not supplied

Determination of trace elements in standard reference materials by the ko-standardization method.

The ko-standardization method is suitable for routine multielement determinations by reactor neutron activation analysis (NAA). Investigation of NIST standard reference materials SRM 1571 Orchard Leaves, SRM 1572 Citrus Leaves, and SRM 1573 Tomato Leaves showed the systematic error of 12 certified elements determined to be less than 8%. Thirty-four elements were determined in NIST proposed SRM 1515 Apple Leaves.

Neutron Activation Analysis↗
PubMed1989

[Collaborative study of Japanese Pharmacopoeia Heparin Sodium Reference Standard (Control 871)].

Heparin Sodium Reference Standard for Japanese Pharmacopoeia (JP) is replaced with new material derived from porcine mucosa. The material was dissolved in water, distributed to vials and freeze-dried. The anticoagulant activity of the freeze-dried product was determined in collaboration with four laboratories employing JP method. The weighted mean potency of 101 assays was 1515 international units per vial, and this value was adopted for the potency of new JP Heparin Sodium Reference Standard (Control 871). By the antiheparin test of protamine sulfate, 0.712 mg of the new standard was neutralized by 1 mg of protamine sulfate. Molecular weight distribution of this standard was also measured by means of gel permeation chromatography and compared with those of the former reference standard and bovine heparin.

Anticoagulants↗
PubMed1967

The National Standard Reference Data system.

The National Standard Reference Data System is a government-wide effort to give to the technical community of the United States optimum access to the quantitative data of physical science, critically evaluated and compiled for convenience. This program was established in 1963 through action of the President's Office of science and Technology and the Federal Council for Science and Technology, acting upon the recommendation of the Council's Committee on Scientific and Technical Information. The National Bureau of Standards has been assigned responsibility for administering the effort. The general object of the system is to coordinate and integrate existing activities in data evaluation and compilation into a systematic comprehensive program, supplementing and expanding technical coverage when necessary, establishing and maintaining standard for the output of the participating groups, and providing mechanisms for dissemination of the output as required. The NSRDS is a decentralized operation of nationwide scope, with central coordination by the Bureau; it comprises a complex of data centers and other activities carried on in government agencies, academic institutions, and nongovernmental laboratories. The independent operational status of existing data projects is maintained and encouraged. Data centers that are components of NSRDS produce compilations of critically evaluated data, critical reviews of the state of quantitative knowledge in specialized areas, and computations of useful functions derived from standard reference data.

Electronic Data Processing↗
PubMed1989

[Prednisolone Reference Standard of National Institute of Hygienic Sciences].

Prednisolone reference standard for the Japanese Pharmacopoeia was prepared. The quality of raw material was examined and compared with the previous reference standard (Control 821). Analytical data for this substance were as follows: loss on drying, 0.04%; melting point, 234.1 degrees C (decomposition); optical rotation, [alpha] 20D + 100.2 degrees; UV spectrum, lambda max = 243 nm; absorptivity, E1%1cm (243 nm) = 415; IR spectrum, 1711, 1655, 1612, 1111, 899 cm-1; one impurity was detected by TLC and high-performance liquid chromatography (HPLC), respectively; assay by HPLC, 100.1%. Based on the above results, this raw material was authorized as the Reference Standard of National Institute of Hygienic Sciences.

Chemical Phenomena↗
PubMed1997

International reference standards: antibody standards for the indirect enzyme-linked immunosorbent assay.

Reference standards are used to calibrate similar assay systems against an international reference protocol and to provide a template for the preparation of secondary and/or working standards. Three reference standards are recommended for the indirect enzyme-linked immunosorbent assay: a strong positive standard, a weak positive standard and a negative serum standard. The negative standard should be derived from a single serum or from a serum pool which exhibits typical background activity in the reference protocol. The strong and weak positive standards should be derived from a single serum or from a serum pool which typifies the humoral response (antibody) to natural infection. Suitable candidates for the positive reference standards should exhibit dose/response curves in the mid-range of antibody activity. The strong and weak positive standards should each be prepared from a one-time dilution in the negative standard, to yield antibody activities which are defined by specific points on the linear portion of the dose/response curve. The strong positive standard should represent an antibody activity (absorbance value) midway between the upper and central points and the weak positive standard should represent an antibody activity midway between the central and lower points of the linear portion of the curve. Owing to inherent differences among assay systems, antibody activities should be expressed in relative rather than in absolute terms. It is recommended that the antibody activity of the strong positive standard should denote 100% positivity. The activities of the weak positive and negative standards should then be expressed as relative percentages. Every set of international reference standards should be accompanied by an information sheet which includes, among other things, a plot of the dose/response curve and an indication of the dilutions used to prepare the standards.

Animals↗