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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↗
PubMed2001

A review of the DNA standard reference materials developed by the National Institute of Standards and Technology.

The Standard Reference Materials Program at the US National Institute of Standards and Technology (NIST) has three human DNA standard reference materials (SRM 2390, SRM 2391a, and SRM 2392) currently available [1, 2]. Both the DNA profiling SRM 2390 and the polymerase chain reaction (PCR)-based DNA profiling SRM 2391a are intended for use in forensic and paternity identifications, for instructional law enforcement, or for non-clinical research purposes and are not intended for clinical diagnostics. The mitochondrial DNA (mtDNA) SRM 2392 is to provide standardization and quality control when performing PCR and sequencing any segment or the entire 16,569 base pairs that comprise human mitochondrial DNA. SRM 2392 is designed for use by the forensic, medical, and toxicological communities for human identification, disease diagnosis or mutation detection.

DNA↗
PubMed2002

Value assignment of nutrient concentrations in standard reference material 2384 baking chocolate.

Standard Reference Material (SRM) Baking Chocolate was recently issued, and the process used for value assignment of nutrient concentrations is reported herein. SRM 2384 is intended for use as a primary control material for assigning values to in-house control materials and for validation of analytical methods for the measurement of fatty acids, proximates, vitamins, and elements in chocolate and similar high-fat matrices. The Certificate of Analysis for SRM 2384 provides assigned values for concentrations of fatty acids, proximates, vitamins, elements, and total dietary fiber, for which product labeling is required by the Nutrition Labeling and Education Act of 1990, as well as for catechins, caffeine, theobromine, and theophylline. These assigned values were based on measurements by NIST and/or collaborating laboratories.

Cacao↗
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↗
PubMed2002

Direct calibration of a reference standard against the air kerma strength primary standard, at 192Ir HDR energy.

The primary standard of low air kerma rate sources or beams, maintained at the Radiological Standards Laboratory (RSL) of the Bhabha Atomic Research Centre (BARC), is a 60 cm3 spherical graphite ionization chamber. A 192Ir HDR source was standardized at the hospital site in units of air kerma strength (AKS) using this primary standard. A 400 cm3 bakelite chamber, functioning as a reference standard at the RSL for a long period, at low air kerma rates (compared to external beam dose rates), was calibrated against the primary standard. It was seen that the primary standard and the reference standard, both being of low Z, showed roughly the same scatter response and yielded the same calibration factor for the 400 cm3 reference chamber, with or without room scatter. However, any likelihood of change in the reference chamber calibration factor would necessitate the re-transport of the primary standard to the hospital site for re-calibration. Frequent transport of the primary standard can affect the long-term stability of the primary standard, due to its movement or other extraneous causes. The calibration of the reference standard against the primary standard at the RSL, for an industrial type 192Ir source maintained at the laboratory, showed excellent agreement with the hospital calibration, making it possible to check the reference chamber calibration at RSL itself. Further calibration procedures have been developed to offer traceable calibration of the hospital well ionization chambers.

Air↗
PubMed2003

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

The "Lysozyme Reference Standard (Control 951031)" of the National Institute of Health Sciences was prepared. The lysozyme potency of the standard material was assayed against the Lysozyme Reference Standard (Control 951) by turbidimetric method two turbidimetric methods using the dried y-cells of Micrococcus luteus as a substrate. The potency of the standard material was in satisfactory agreement with that of Lysozyme Reference Standard (Control 951) and was defined as 1 mg [potency] per mg.

Amino Acids↗
PubMed1998

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

The "Thrombin Reference Standard (Control 961)" of National Institute of Health Sciences was prepared. The precision of filling into ampoule was about 1% as C.V. The content of a-thrombin was about 87%. The thrombin potency of the standard material was assayed against the Thrombin Reference Standard (Control 8710) according to the method of JP XIII and the potency was 1033 +/- 59 unit/ampoule. From the results, the potency of the proposed material for Thrombin Reference Standard was defined as 1,030 units per ampoule.

Government Agencies↗
PubMed2003

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

The "Thrombin Reference Standard (Control 031", of National Institute of Health Sciences was prepared. The precision of filling into ampoule was about 11.5% as C.V. The content of alpha-thrombin was about 89%. The thrombin potency of the standard material was assayed against the Thrombin Reference Standard (Control 961) according to the method of JP-X IV and the potency was 692 +/- 35 units/ampoule. From the results, the potency of the proposed material for Thrombin Reference Standard was defined as 690 units per ampoule.

Electrophoresis, Polyacrylamide Gel↗
PubMedDate not supplied

The certification of morphine and codeine in a human urine standard reference material.

The National Institute of Standards and Technology (NIST, formerly the National Bureau of Standards) has developed and certified a Standard Reference Material, SRM 2381, for use in testing for bias in determinations of morphine and codeine in human urine. Each unit of this SRM consists of three vials with different levels of morphine and codeine in lyophilized urine. Three different analytical methods, employing GC/MS, LC/MS, and MS/MS, were used to certify the concentrations of each analyte. Results from the three methods were in good agreement and, therefore, were statistically combined to yield certified values of 138, 293, and 578 ng/mL for morphine and 134, 283, and 591 for codeine. A round-robin study on this material among nine military laboratories demonstrated the suitability of the SRM for its intended purpose.

Chromatography, Liquid↗
PubMed1996

[Lysozyme Reference Standard (Control 951) of the National Institute of Health Sciences].

The "Lysozyme Reference Standard (Control 951)" of the National Institute of Health Sciences was prepared. The lysozyme potency of the standard material was assayed against the Lysozyme Reference Standard (Control 915) by two turbidimetric methods using the drycells of Micrococcus luteus as the substrate. The potency of the standard material was in satisfactory agreement with that of Lysozyme Reference Standard (Control 915) and was defined as 1 mg [potency] per mg.

Amino Acids↗
PubMed1998

[Kallidinogenase Reference Standard (Control 971) of National Institute of Health Sciences].

The "Kallidinogenase Reference Standard (Control 971)" of National Institute of Health Sciences was prepared. The kallidinogenase potency of the standard material was assayed against the 2nd Kallidinogenase Reference Standard (Control 854) by the enzyme assay method using H-D-valyl-L-leucyl-L-arginine-p-nitro-anilide as the substrate. The potency of the Kallidinogenase Reference Standard material thus obtained was defined as 119 unit per ampoule.

Government Agencies↗