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At least 145 records · Page 8Linked to original sources
PubMed1996

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

The "Sennosides Reference Standard (Control 951)" was prepared, which is intended to be used for the fluorophotometric assay of sennosides content in the preparation of "Sennosides". In this assay hydroxylated mono- and dianthraquinone glucosides are chelated with boric acid, and the fluorescence intensity of the chelate is determined against that of the Reference Standard (RS). In the establishment of this RS, sennosides content in the candidate material must be determined accurately by fluorophotometry. The Sennoside AB for assay, prepared as an equimolar mixture of the purified sennoside A and Sennoside B, was used as the RS for the fluorophotometry. Based on the above concept, sennosides content in the candidate was determined as calcium salts to be 60.1 +/- 1.6% by the fluorophotometry. Thus the sennosides content of this Sennosides RS was certified to be 60%. Separately, contents of Sennoside A (SA) and Sennoside B (SB) in this candidate were determined by using HPLC. As a result, the sum of SA and SB was estimated to be 38% as free acids. Thus it was suggested that about 20% of dianthraquinone glucosides other than SA and SB and anthraquinone glucosides may be included in this Sennoside RS as free acids. Analytical results on the USP Sennosides RS were also shown and discussed, compared with the present Sennosides RS.

Anthraquinones↗
PubMed1990

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

Methyldigoxin was tested for preparation of the "Methyldigoxin Reference Standard (Control 881)". Analytical data obtained were as follows: infrared spectrum 3456, 1738, 1086 cm-1; ultraviolet spectrum lambda max = 219 nm; absorbance E1cm1% (219 nm) = 193.1; water 0.99%; optical rotation [alpha]546.1(20) = +22.5 degrees; thin-layer chromatography and high-performance liquid chromatography indicates two impurities, respectively; quantitative analysis of acetone 3.87%; assay by spectrophotometry 100.3% against Digoxin Reference Standard (Control 802). On the basis of the above results, this material was authorized as the National Institute of the Hygienic Sciences Reference Standard (Control 881).

Chromatography, High Pressure Liquid↗
PubMed1997

[Epinephrine Bitartrate Reference Standard (Control 951) of National Institute of Health Sciences].

The raw material for epinephrine bitartrate was tested for preparation of the "Epinephrine Bitartrate Reference Standard (Control 951)" of National Institute of Health Sciences. Analytical data obtained were as follows: melting point, 148.6 degrees C (decomposition); UV spectrum, lambda max = 279 nm; IR spectrum, the same as that of JP Epinephrine Bitartrate Reference Standard (Control 792); optical rotation, [alpha]20D = -52.8 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography, no impurity was detected; loss on drying, 0.01%; assay, 99.6% by potentiometric titration, 100.3% by spectrophotometry. Based on the above results, the raw material was authorized as the Epinephrine Bitartrate Reference Standard (Control 951) of National Institute of Health Sciences (Japanese Pharmacopoeia).

Epinephrine↗
PubMed1997

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

The raw material for chlormadinone acetate was tested for preparation of the "Chlormadinone Acetate Reference Standard (Control 961)" of National Institute of Health Sciences. Analytical data obtained were as follows: melting point, 215. 3 degrees C; UV spectrum, lambda max = 283.5 nm; IR spectrum, the same as that of JP Chlormadinone Acetate Reference Standard (Control 885); optical rotation, [alpha]20D = -13.0 degrees; thin-layer chromatography, one impurity was detected; high-performance liquid chromatography, two impurities were detected; loss on drying, 0.01%; assay, 99.4% by spectrophotometry and 99.5% by HPLC. Based on the above results, the raw material was authorized as the Chlormadinone Acetate Reference Standard (Control 961) of National Institute of Health Sciences (Japanese Pharmacopoeia).

Chlormadinone Acetate↗
PubMed1999

[Fluocinolone Acetonide Reference Standard (Control 981) of National Institute of Health Sciences].

The raw material of fluocinolone acetonide was examined for preparation of the "Fluocinolone Acetonide Reference Standard (Control 981)". The analytical data obtained were: melting point, 271.5 degree C; UV spectrum, Lambda max of 237.0 nm and specific absorbance in ethanol at 237 nm of 359.3; IR spectrum, same as that of the Fluocinolone Acetonide Reference Standard (Control 904); optical rotation, [alpha]20(D) = + 102.8; thin-layer chromatography, no impurities detected; high-performance liquid chromatography, one impurity detected and total amount estimated to be about 0.17%; loss on drying, 0.29%; assay by HPLC, 100.9%. Based on the above results, the raw material was authorized as the Fluocinolone Acetonide Reference Standard (Control 981) of the National Institute of Health Sciences.

Fluocinolone Acetonide↗
PubMed2001

[Beclometasone Dipropionate Reference Standard (Control 011) of National Institute of Health Sciences].

The raw material of beclometasone dipropionate was examined for the preparation of the "Beclometasone Dipropionate Reference Standard (Control 011)". The analytical data obtained were: melting point, 208.8 degrees C; optical rotation, [alpha]D20 = +91.7 degrees; IR spectrum, same as that of the Beclometasone Dipropionate Reference Standard (Control 865); thin-layer chromatography, one impurity was detected until 40 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.5%; loss on drying, 0.6%. Based on the above results, the raw material was authorized as the Beclometasone Dipropionate Reference Standard (Control 011) of the National Institute of Health Sciences.

Beclomethasone↗
PubMed2004

From milk to solids: a reference standard for the transitional eating process in infants and preschool children in Japan.

OBJECTIVE: This paper aims to establish a potential reference standard for the process of transition from milk to solid food in infants and preschool children in Japan, using the transitional food process (TFP) scale described by Sakashita et al. The background for variation and delay in the process are also discussed. DESIGN: A randomized sample survey covering entire Japan. SETTING: Mailing self-completion of questionnaires. SUBJECTS: Randomized sample of 14 000 children aged 0-6 y and their family from 13 prefectures in Japan, namely Hokkaido, Aomori, Iwate, Niigata, Tokyo, Saitama, Fukui, Nagano, Nagoya, Hyogo, Yamaguchi, Kagoshima, and Okinawa. METHODOLOGY: Questionnaires requesting the TFP scale and background factors were sent to 14,000 children and families. The percentile ages were calculated. An eating ability index (EAI: number of accepted foods/total number of foods) x 100) was calculated. Regression analysis by analysis of covariance (ANCOVA; SPSS, 1997) was used to determine the influence of background factors on EAI. RESULTS: From the 6747 (48.2%) effective answers received, percentile curves of the acceptability of each food on the scale were drawn, and used as initial reference standards. The 50 percentile age range of these 20 standard foods covers from 5 to 42 months after birth. The sensitive period for increasing the acceptance of foods in children was between 6 months and 2(1/2) y of age. ANCOVA regression model (R2=0.605) showed that EAI was mostly influenced by age (P=0.000), followed by feeding style (P=0.000), infant food preparation (P=0.000), information source (P=0.000), and birth order (P=0.003). The dominant cause of digestive system problems was shown to be infection, not too-hard food. It seems that breast feeding, bottle feeding with chewing-type nipples, and the manner of preparing infant foods from the family table promote the progress in acceptance. Children whose mothers followed the information given in books or magazines showed a slower progress. CONCLUSIONS: It seems appropriate to use this reference standard in the study of the transitional process from milk to solid food in infants and preschool children in Japan.

Age Factors↗
PubMed2003

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

The raw material of tocopherol acetate was examined for the preparation of the "Tocopherol Acetate Reference Standard (Control 021)", The analytical data obtained were: UV spectrum, lambda max of 278.5 and 284.8 nm and specific absorbance in ethanol at 284 nm = 42.9; IR spectrum, same as that of the Tocopherol Acetate Reference Standard (Control 001); thin-layer chromatography, no impurities were detected until 50 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.6%. Based on the above results, the raw material was authorized as the Japanese Pharmacopoeia Tocopherol Acetate Reference Standard (Control 021) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗
PubMed2005

Determination of dibenzopyrenes in standard reference materials (SRM) 1649a, 1650, and 2975 using ultrasonically assisted extraction and LC-GC-MS.

A method has been developed for analysis of the highly potent polycyclic aromatic hydrocarbon (PAH) carcinogens dibenzo(a,l)pyrene, dibenzo(a,h)pyrene, and dibenzo(a,i)pyrene (molecular weight 302) present in small amounts in diesel and air particulate material. The method can also be used for analysis of the PAH benzo(a)pyrene, coronene, and perylene, for which reference and certified values are available for the standard reference materials used for validation of the method--SRM 1649a (urban dust) and SRM 2975 (diesel particulate matter). The only NIST values that have been published for these dibenzopyrene isomers in the analyzed SRM are reference values for dibenzo(a,i)pyrene and dibenzo(a,h)pyrene in SRM 1649a. The concentrations determined in the SRM were in good agreement with reported NIST-certified and reference values and other concentrations reported in the literature. Standard reference material 1650 (diesel particulate matter) was also analyzed. The method could not, however, be validated using this material because certification of SRM 1650 had expired. The method is based on ultrasonically assisted extraction of the particulate material, then silica SPE pre-separation and isolation, and, separation and detection by hyphenated LC-GC-MS. The method is relatively rapid and requires only approximately 1-5 mg SRM particulate material to identify and quantify the analytes. Low extraction recoveries for the analytes, in particular the dibenzopyrenes, when extracting diesel SRM 2975 and 1650 resulted, however, in the dibenzopyrenes being present in amounts near their limits of quantifications in these samples. The method's limit of quantification (LOQ), based on analyses of SRM 1649a, is in the range 10-77 pg. By use of this method more than 25 potential PAH isomers with a molecular weight of 302 could be separated.

Journal Article↗
PubMed1984

Determination of the chemical constituents and spectral properties of commercial and NF reference standard potassium guaiacolsulfonate: implications of the findings on compendial analytical methodology.

HPLC analysis confirmed a difference in the chemical composition of commercial versus NF reference standard potassium guaiacolsulfonate. After separation by fractional crystallization, the two constituents comprising the former sample were identified by 1H-NMR as potassium guaiacol-4- and -5-sulfonate, respectively. The former isomer predominated. The reference standard material was identified as the 4-sulfonate salt by HPLC, NMR, IR, and UV. This difference raises questions concerning the validity of the compendial identification tests and assay procedure for the drug, which are based on methods requiring direct comparison between it and the reference standard. In fact, the IR test has now been shown to be unreliable as a rigorous criterion for identification, in light of significant differences found in the fingerprint regions of the spectra of the two isomers. However, because the two isomers exhibit identical UV absorption characteristics in solutions of pH less than or equal to 7 (but not in alkaline solution), the compendial UV identification test and assay procedure appear to be valid under the conditions specified. The pKa values of the isolated isomers were estimated by a spectrophotometric method to be 8.74 and 9.16 for the phenolic group of potassium guaiacol-4- and -5-sulfonate, respectively.

Acetylation↗
PubMed1996

[dl-Camphor Reference Standard (Control 951) of the National Institute of Health Sciences].

The raw material of dl-camphor was examined for the preparation of the "dl-Camphor Reference Standard". Analytical data obtained are as follows: ultraviolet spectrum, lambda max = 290 nm; infrared spectrum, the same as that of the present JP Camphor Reference Standard; melting point, 179.6 degrees C; purity test by gas-chromatography (GC), three kinds of impurities were detected; assay by GC, 99.0%. Based on the above results, the candidate raw material was authorized as the JP Reference Standard (Control 951).

Camphor↗
PubMed1998

[Potassium Sucrose Octa Sulfate Reference Standard (Control 961) of National Institute of Health Sciences].

The raw material of potassium sucrose octa sulfate was examined for the preparation of the "Potassium Sucrose Octa Sulfate Reference Standard (Control 961)". Analytical data obtained were as follows: infrared spectrum, the same as that of the Potassium Sucrose Octa Sulfate Reference Standard (Control 901); high-performance liquid chromatography, one impurity was detected; water content, 8.1%; assay of sucrose octa sulfate, 99.6%. Based on the above results, the raw material was authorized to be the Potassium Sucrose Octa Sulfate Reference Standard of the National Institute of Health Sciences.

Government Agencies↗
PubMed1994

[The Alprostajil Reference Standard (Control 921) of the National Institute of Health Sciences].

Raw alprostajil material was examined for preparation of the "Alprostajil Reference Standard (Control 921)". Analytical data obtained were as follows: infrared spectrum, the same as that of the USP Alprostajil Reference Standard; thin-layer chromatography, no impurities were detected up to 20 micro g; high-performance liquid chromatography (HPLC), no impurities were detected; assay result, 99.6% by HPLC. Based on the above findings, this raw material was authorized as the NIHS Alprostajil Reference Standard (Control 921).

Alprostadil↗
PubMed1997

[dl-Camphor Reference Standard (Control 961) of National Institute of Health Sciences].

The raw material of dl-camphor was examined for the preparation of the "dl-Camphor Reference Standard (Control 961)" of National Institute of Health Sciences. Analytical data obtained are as follows: UV spectrum, lambda max = 290 nm; IR spectrum, the same as that of the present JP Camphor Reference Standard (Control 953); melting point, 179.1 degrees C; purity test by gas-chromatography (GC), three kinds of impurities were detected; assay by GC, 99.8%. Based on the above results, the candidate raw material was authorized as the dl-Camphor Reference standard (Control 961) National Institute of Health Sciences (Japanese Pharmacopoeia).

Camphor↗
PubMed1999

Meta-analysis of diagnostic tests with imperfect reference standards.

We present a method to estimate the summary receiver operating characteristic (SROC) curve for combining information on a diagnostic test from several different studies. Unlike previous methods that assume the reference standard to be error free, our approach allows for the possibility of errors in the reference standard, through use of a latent class model. The model provides estimates of the sensitivity and specificity of the diagnostic test and the case prevalence in each study; these parameters can then be used in a meta-analysis, for example, using the regression method proposed by Moses et al., of a measure of test discrimination on a measure of the diagnostic threshold, to fit the SROC. The method is illustrated with an example on Pap smears that shows how adjusting for imperfection in the reference standard typically reduces the scatter of data in the SROC plot, and tends to indicate better performance of the test than otherwise.

Algorithms↗
PubMed2000

[Prednisolone Sodium Phosphate Reference Standard (Control 001) of National Institute of Health Sciences].

The raw material for prednisolone sodium phosphate was examined for the preparation of the "Prednisolone Sodium Phosphate Reference Standard (Control 001)". The analytical data obtained were: pH, 7.9; optical rotation, [alpha]D20 = +98.0 degrees; UV spectrum, lambda max of 248 nm and specific absorbance in ethanol at 248 nm = 306.7; IR spectrum, same as that of the Prednisolone Sodium Phosphate Reference Standard (Control 892); thin-layer chromatography, five impurities were detected at 200 micrograms; high-performance liquid chromatography (HPLC), total amount of impurities estimated to be less than 3.7%; residual solvent, 0.0% (ethanol) and 0.0% (hexane); loss on drying, 2.7%. Based on the above results, the raw material was authorized as the Prednisolone Sodium Phosphate Reference Standard (Control 001) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗
PubMed2001

[Dexamethasone Sodium Phosphate Reference Standard (Control 001) of National Institute of Health Sciences].

The raw material for dexamethasone sodium phosphate was examined for the preparation of the "Dexamethasone Sodium Phosphate Reference Standard (Control 001)". The analytical data obtained were: pH, 8.0; optical rotation, [alpha]D20 = +79.6 degrees; UV spectrum, lambda max of 242 nm and specific absorbance in water at 242 nm = 313.6; IR spectrum, same as that of the Dexamethasone Sodium Phosphate Reference Standard (Control 893); free phosphoric acid, 0.06%; free dexamethasone, 0.07%; thin-layer chromatography, no impurities were detected until 100 micrograms; high-performance liquid chromatography, total amount of impurities estimated to be less than 0.2%; residual solvent, 4.3% (ethanol); water, 7.3%. Based on the above results, the raw material was authorized as the Dexamethasone Sodium Phosphate Reference Standard (Control 001) of the National Institute of Health Sciences.

Chromatography, High Pressure Liquid↗
PubMed1994

[The Cyanocobalamin Reference Standard (Control 931) of the National Institute of Health Sciences].

Raw cyanocobalamin material was tested for preparation of the "Cyanocobalamin Reference Standard (Control 931)". Analytical data obtained were as follows: loss on drying, 4.2%; infrared spectrum, the same as that of the JP Cyanocobalamin Reference Standard (Control 901); thin-layer chromatography, four impurities were detected; high-performance liquid chromatography (HPLC), seven to eight kinds of impurities were detected, but the total amount of impurities was only 1.0 +/- 0.52% (n = 5); assay results, 100.6% by spectrophotometry in the JP XII and 99.7% by HPLC. Based on the above findings, the raw material was authorized as the JP Cyanocobalamin Reference Standard (Control 931).

Chemical Phenomena↗