Japanese Pharmacopoeia Research Articles

B-335 Analytical Performance of the Novel EQA Material for Fecal Immunochemical Test for Hemoglobin

Abstract Background EQA (external quality assurance) program for FIT (fecal immunochemical test for hemoglobin) is performed in many countries, and its demand increases as FIT is widely used in organized colorectal cancer screening programs. The materials used in FIT EQA vary from buffer-based liquid control, and lyophilized stool, to material that mimics stool, artificial stool. We could not find ideal EQA material with hemoglobin uniformly contained, good stability of hemoglobin, and ease in use such as ready-to-use form. The merit to use material that simulates actual sample, stool, is not only to be compliant with ISO15189 but also to suit various methods and sampling devices in FIT. The development of artificial stool material has been awaited by laboratories using FIT to evaluate errors and precisions in specimen collection.We assessed the analytical performance of the new artificial stool developed in HECTEF (Health Care Technology Foundation) to evaluate this artificial stool material was suitable as an EQA material. We examined the following three points: 1) Sample collection, 2) Uniformity, and 3) Stability of hemoglobin. Methods 1) Sample collection: The material was collected with the sampling probes of OC-Auto Sampling Bottle 3 (Eiken Chemical) and the collection amount was calculated by comparing the weight before and after sampling the artificial stool. 2) Uniformity: The uniformity of hemoglobin was evaluated during production before and after bottling based on “Uniformity of dosage units” section of The Japanese Pharmacopoeia 18th edition, 2021. The material was sampled from 10 different points and hemoglobin concentrations were measured using OC-Sensor DIANA. The uniformity of hemoglobin between the vials was evaluated by calculating the CV from the average of hemoglobin concentrations from samples of three points from three vials. 3) Stability of hemoglobin: The materials stored under different temperature conditions were compared with the material stored frozen at -20 °C. Storage conditions were at refrigeration for 20 months, at 30 °C for 1 month, and freeze-thawing for five times. Evaporation from the material was evaluated by weighing the samples before and after storage at 30 °C for 1 month. Results 1) Sample collection: The material was collected with sampling probes and the collection amounts were 106% (compared to theoretical amount).2) Uniformity: Uniformity of hemoglobin during production was within the specification of “Uniformity of dosage units” section of the pharmacopoeias, acceptance value<15.0. Uniformity of hemoglobin among three vials was within ±10% CV.3) Stability of hemoglobin: Stabilities of the material were all within ±10% from the control material (frozen) after storage at all temperature conditions. Evaporation from the material in a vial was below 1% at 30 °C storage for 1 month. Conclusions This artificial stool is suitable for EQA material because it is confirmed that it shows favorable analytical results in sample collection, uniformity, and stability of hemoglobin. The evaluation of this material in the EQA program to show its suitability was performed by Labquality. The result is reported in a poster at ADLM 2024.

Development of a determination method for quality control markers utilizing metabolic profiling and its application on processed Zingiber officinale Roscoe rhizome.

This study established an Orthogonal Partial Least Squares (OPLS) model combining 1H-NMR and GC-MS data to identify characteristic metabolites in complex extracts. Both in metabolomics studies, and natural product chemistry, the reliable identification of marker metabolites usually requires laborious isolation and purification steps, which remains a bottleneck in many studies. Both ginger (GR) and processed ginger (PGR) are listed in the Japanese pharmacopeia. The plant of origin, the rhizome of Zingiber officinale Roscoe, is differently processed for these crude drugs. Notably, the quality of crude drugs is affected by genetic and environmental factors, making it difficult to maintain a certain quality standard. Therefore, characteristic markers for the quality control of GR and PGR are required. Metabolomic analysis using 1H-NMR was able to discriminate between GR and PGR, but there were unidentified signals that were difficult to distinguish based on NMR data alone. Therefore, we combined 1H-NMR and GC-MS analytical data to identify them by OPLS. As a result, αr-curcumene was found to be a useful marker for these identifications. This new approach enabled rapid identification of characteristic marker compounds and reduced the labor involved in the isolation process.

An Alternative Microbiological Validation for an Online Water Bioburden Analyzer.

The Mettler-Toledo 7000RMS analyzer is a Bio-Fluorescent Particle Counter (BFPC) used to monitor real-time bioburden results from Purified Water (PW). Validation of the analyzer using 13 microorganisms and a low-intensity, fluorescent, polystyrene bead. During the execution of the validation, a laboratory water system that met Purified Water (PW) quality standards was connected to the 7000RMS, and a syringe pump was used to introduce various concentrations of microorganisms and fluorescent polystyrene beads to the analyzer. Samples were collected and tested via the traditional Membrane Filtration (MF) method and the Colony Forming Unit (CFU) plate count results were compared to the Auto-Fluorescent Unit (AFU) of the 7000RMS analyzer. The validation study was designed to follow the guidance in United States Pharmacopeia (USP) Chapter <1223 > (1), European Pharmacopeia (EP) Chapter 5.1.6 (2), PDA Technical Report 33 (3). Concepts and strategies were adapted from EP Chapter 2.6.12 Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests, EP 10.2 (4), European Pharmacopeia Chapter 2.6.1 Sterility, EP 10.2 (5), USP Chapter <61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests (6), USP Chapter <71> Sterility Tests (7), Japanese Pharmacopoeia (JP) General Information Chapter G8 Water: Quality Control of Water for Pharmaceutical Use (8). All pre-determined validation acceptance criteria for Accuracy, Specificity, Precision, Limit of Detection (LOD), Limit of Quantitation (LOQ), Linearity, and Range were met. Further, the 7000RMS demonstrated Performance Equivalence to the MF method per USP <1223> but characteristically lacked correlation to the CFU. This validation approach highlights the superior capabilities of the 7000RMS when compared against the traditional compendial MF testing method for PW.

Comparison of Menthae Herba written with the same kanji characters () in Japan and China.

Menthae Herba is an herbal medicine whose name is written with the same kanji characters () in both the Japanese Pharmacopoeia, 18th Edition (JP) and in the Pharmacopoeia of the People's Republic of China (CP). However, the original plant are Mentha arvensis Linné var. piperascens Malinvaud in JP and Mentha haplocalyx Briq. in CP. To clarify the similarities and differences between Menthae Herba in Japan and that in China, morphological observations, essential oil component analysis, and DNA analysis were performed on marketed products of Menthae Herba in Japan and in China. The morphological observations based on the description of JP Menthae Herba showed that most of the samples matched the items listed in the description. Essential oil component analysis by gas chromatography-mass spectrometry showed that the amount of menthol varied among samples and that menthol was not always the principal compound in the oil. The original plant species was confirmed by DNA analysis of the rpl16 intron region in chloroplast DNA and all samples matched the sequence of M. canadensis. The results showed that Menthae Herba products distributed in both Japan and China contained M. canadensis, but they had different compositions of essential oil, with menthol-rich Menthae Herba being dominant in the Japanese market.

Dissolution Profiles of Immediate Release Products of Various Drugs in Biorelevant Bicarbonate Buffer: Comparison with Compendial Phosphate Buffer

PurposeThe purpose of this study was to clarify the extent to which the dissolution profiles of immediate release (IR) products of various drugs differ between biorelevant bicarbonate buffer (BCB) and compendial phosphate buffer (PPB).MethodsThe dissolution profiles of the IR products of fifteen poorly soluble ionizable drugs were measured in BCB and PPB. BCB was set to be relevant to the small intestine (pH 6.8, 10 mM). The pH was maintained using the floating lid method. The Japanese pharmacopeia second fluid (JP2, 25 mM phosphate buffer, nominal pH 6.8) was used as compendial PPB. The compendial paddle apparatus was used for the dissolution tests (500 mL, 50 rpm, 37°C).ResultsIn 11/15 cases, a difference in dissolved% (< 0.8 or > 1.25-fold) was observed at a time point. In 4/15 cases, the ratio of the area under the dissolution curve was not equivalent (< 0.8 or > 1.25-fold). In the cases of free-form drugs, the dissolution rate tended to be slower in BCB than in JP2. In the case of salt-form drugs, a marked difference was observed for the cases that showed supersaturation. However, no trend was observed in the differences.ConclusionsMany IR products showed differences in the dissolution profiles between biorelevant BCB and compendial PPB. With the floating lid method, BCB is as simple and easy to use as PPB. Biorelevant BCB is recommended for dissolution testing.

Route to the Adoption of Quantitative NMR in the Japanese Pharmacopoeia

Quantitative NMR (qNMR) is employed to determine the purity of reagents used as standards for HPLC quantification in the Japanese Pharmacopoeia (JP) and has become recognized as a new absolute quantification method in various fields such as pharmaceuticals, foods, and food additives. This report outlines how and why qNMR has been adopted as an official method in the JP and introduces its progression from JP16 to JP18. The results of a survey of companies in the Japan Pharmaceutical Manufacturers' Association regarding how and when to use qNMR from development to manufacturing stages are introduced. The issues involved in the expansion of the use of qNMR in the field of chemical pharmaceuticals in 2017 are discussed and how these were resolved.

The Applications of qNMR in Drug Quality Control

NMR is well known as one of the most important methods for elucidating the structure of organic compounds. Furthermore, it has recently been recognized as a powerful tool for quantitative analysis. The quantitative NMR (qNMR) has become an official analytical method described in detail in the Japanese Pharmacopoeia. And today, it is widely applied in drug development. The qNMR method offers many new advantages over traditional and conventional quantitative analysis methods. For example, this method requires only a few milligrams of the analyte and allows absolute quantitation of the analyte without using a qualified reference standard as a control sample. Then, it can be easily applied to most chemicals without expending significant time and resources on method development. In addition, residual solvent can be determined using qNMR methods. The peak area of an NMR spectrum is directly proportional to the number of protons contributing to the resonance. Based on this principle, the residual solvent can be determined by counting the signal corresponding to the residual solvent in the sample solution. We have applied qNMR as an alternative to GC. Thus, qNMR is an innovative and promising analytical technique that is expected to make significant progress in the future. Recently, the analytical research and quality control departments have been working together to expand this technology to a wide range of areas in the pharmaceutical industry.

High Purity Solvents for qNMR Measurement

Quantitative NMR (qNMR) has been adopted by documentary standards, including the Japanese Pharmacopoeia (JP), United States Pharmacopoeia (USP), and International Organization for Standardization (ISO), owing to its reliability and efficiency. Note that qNMR can be used for quantifying target components using the signal integration ratio of an analyte to a reference. In qNMR, a modern NMR instrument with high resolution and sensitivity is used to record reliable spectra. This instrument can detect small signals from impurities in a solvent, which may result in inaccurate signal integration in the spectrum. In this study, we investigated the influence of solvent quality on qNMR accuracy focusing on organic impurities, water content, and deuteration ratio. If signals from organic impurities and signals from the analyte overlap, the duplication of signal integration will directly affect the qNMR analytical result. To examine overlapping, we performed blank solvent tests. Additionally, a high water content and low deuteration ratio affect the detection sensitivity, thus reducing the signal-to-noise (S/N) ratio of the target. Thus, these factors must be considered to obtain accurate qNMR results.

Evaluation of single granule release characteristics of controlled release granules with porous ethylcellulose membrane

A basic dissolution study of single granule in a controlled-release capsule formulations was conducted. Controlled-release granules were prepared using porous Ethylcellulose membranes, and single granule dissolution profiles was compared with those of the Japanese pharmacopoeia (JP) paddle method. Dissolution profile from one granule was found to be dependent on the solubility of the drug.

TM-MC 2.0: an enhanced chemical database of medicinal materials in Northeast Asian traditional medicine

BackgroundAs chromatographic techniques have advanced, many articles that analyze the constituting compounds of medicinal materials have been published in relation to Northeast Asian traditional medicine, including traditional Chinese medicine (TCM). TM-MC was launched in 2015, providing information about the chemical compounds in medicinal materials from chromatographic articles in PubMed. Since 2015, through continuous curation efforts, we have now released TM-MC 2.0 with significant improvements to the quantity and quality of the data (https://tm-mc.kr).DescriptionTM-MC 2.0 contains 635 medicinal materials, 34,107 chemical compounds (21,306 identified and de-duplicated), 13,992 targets, 27,997 diseases, and 5,075 prescriptions (2,393 de-duplicated by name). The database provides the largest number of identified compounds for medicinal materials listed in the pharmacopoeia compared to all TCM databases. In particular, marker compounds of medicinal materials and many newly discovered compounds were added through the manual curation of recent chromatographic articles.ConclusionTM-MC 2.0 provides the largest collection of information about the chemical compounds of the medicinal materials listed in the Korean, Chinese, and Japanese pharmacopoeias. Our database can be utilized for network pharmacology in traditional medicine and for the compound screening of medicinal materials for modern drug discovery.

Monograph on the Use of Herbs to Address Metabolic Syndrome

IntroductionMetabolic syndrome is a collection of symptoms that have become an issue on a global scale. While allopathic medicine can address the downstream symptoms, the metabolic pathways that are the root cause of the syndrome can be managed using herbs. MethodsCriteria for the syndrome were set by the World Health Organization. Suggested herbs are taken from World Health Organization monographs, the British Pharmacopoeia, the United States Pharmacopoeia and the National Formulary, the Ayurvedic Pharmacopoeia, the Pharmacopoeia of the People's Republic of China, and the Japanese Pharmacopoeia. Herbs are cross-referenced with the primary literature when possible. Dietary recommendations and supplements are mentioned tangentially; however, they are not the intended focus of this monograph. ResultsHyperglycemia is considered a principal component and driver of metabolic syndrome. Insulin resistance, glycolysis, and insulin production can all be affected by herbs. Lipid metabolism occurs primarily in the liver; liver function can be enhanced using herbs. Inflammation caused by a hyperglycemic state can also be managed using herbs and reduced the progression of associated diseases. Since glycolysis and energy production occur in the mitochondria, supporting mitochondrial health with herbs is critical to positively affecting metabolic syndrome. ConclusionsBy using herbs to manage hyperglycemia, inflammation, liver congestion, and mitochondrial health, metabolic syndrome can be slowed, stopped, or even reversed.

Quality Evaluation of Gentamicin Sulfate Reference Standards in Japanese Pharmacopoeia Using Hydrophilic Interaction Chromatography Combined With Tandem Mass Spectrometry.

Through the recent development of analytical technology, antibiotics quantification in the Japanese Pharmacopoeia (JP) has changed from traditional microbiological assays to physicochemical methods with high specificity and precision. However, for several multicomponent antibiotics without typical UV absorption, potency cannot be directly determined using instrumental methods such as high-performance liquid chromatography; therefore, traditional microbiological assays are still used. Gentamicin sulfate (GmS), which consists of three major components, C1, C1a, and C2, is such a typical antibiotic, and its antimicrobial potency continues to be assayed using microbiological methods in JP monographs. Introduction of a physicochemical assay for GmS is needed to help ensure its quality and quantity. This study aimed to develop quality control measures for GmS that could be complementary to quantitative assays and purity tests specified in the JP. For each gentamicin C component (C1, C2, and C1a), theoretical potencies were determined based on the quantitative relationship between purity and potency, as measured by quantitative 1H NMR and microbiological assays, respectively. Two lots of the JP reference standard (RS) were used as test samples, with the contents of each component and impurity (sisomicin and garamine) being determined using hydrophilic interaction liquid chromatography-tandem mass spectrometry (HILIC-MS/MS). The ratios of theoretical potency for C1, C2, and C1a were 1.00, 1.21, and 1.80, respectively. The potencies of the GmS JP RSs, which were estimated based on the contents and theoretical potency of each C component, corresponded well with those determined through microbiological assays. Marked differences in impurities (%) between the two RS lots were highlighted by quantifying sisomicin and garamine. The developed analytical procedure enabled the characterization of two different JP RSs in terms of content ratio, potencies, and impurities. Novel analytical procedures useful for routine quality control of GmS were developed using HILIC-MS/MS.

Quantitative Determination Method of Aconitum Monoester Alkaloids Using Relative Molar Sensitivity (RMS) for the Assay in the Japanese Pharmacopoeia

Recently, a novel quantitative method using relative molar sensitivity (RMS) was applied to quantify the ingredients of drugs and foods. An important development in this regard can be observed in the Japanese Pharmacopoeia (JP) 18, where the quantification of perillaldehyde, an unstable compound, in crude drug "Perilla Herb", was revised to incorporate the RMS method.In this study, the primary objective was to improve the tester safety and reduce the amount of reagents used in the JP test. To achieve this, the quantification of three toxic Aconitum monoester alkaloids (AMAs) was explored using the RMS method, employing a single reference compound for all three targets. These AMAs, namely benzoylmesaconine hydrochloride, benzoylhypaconine hydrochloride, and 14-anisoylaconine hydrochloride, which are the quantitative compounds of Kampo extracts containing Aconite Root (AR), were quantified using the reference compound benzoic acid (BA). Reliable RMS values were obtained using both 1H-quantitative NMR and HPLC/UV. Using the RMS of three AMAs relative to the BA, the AMA content (%) in commercial AMAs quantitative reagents were determined without analytical standards. Moreover, the quantitative values of AMAs using the RMS method and the calibration curve method using the three analytical standards were similar. Additionally, similar values were achieved for the three AMAs in the Kampo extracts containing AR using the RMS and the modified JP18 calibration curve methods. These results suggest that the RMS method is suitable for quantitative assays of the Kampo extracts containing AR and can serve as an alternative to the current method specified in the JP18.

Highly sensitive indirect competitive enzyme-linked immunosorbent assay based on a monoclonal antibody against saikosaponin b2 for quality control of Kampo medicines containing Bupleuri radix.

Saikosaponins are naturally occurring oleanane-type triterpenoids that are found in Bupleuri radix (root of Bupleurum falcatum) and exhibit a broad biological activity spectrum. Saikosaponin b2 (SSb2) is the main saikosaponin in Kampo medicine extracts and is a designated quality control marker for the same in the Japanese Pharmacopeia. Although some monoclonal antibodies (mAbs) against saikosaponins have been produced to evaluate the quality of Bupleuri radix and related products, anti-SSb2 mAbs have not been used to quantify SSb2 in Kampo medicines. To address this knowledge gap, we herein established a new hybridoma cell line secreting a highly specific anti-SSb2 mAb and developed an indirect competitive enzyme-linked immunosorbent assay (icELISA) based on this mAb for the detection of SSb2 in Bupleuri radix-containing Kampo medicines. The generated SSb2-recognized mAb exhibited high specificity to SSb2 in icELISA. The developed assay featured high sensitivity (linearity range = 1.95-125ng/ml), accuracy, precision and reproducibility (coefficient of variation < 5%), and the thus determined SSb2 contents were strongly correlated with those obtained using liquid chromatograph-mass spectrometer. These results suggest that the anti-SSb2 mAb-based icELISA method can be used for the quality control and standardization of Kampo medicines containing Bupleuri radix.

Evaluation of the immune response to diphtheria and tetanus toxoids by the serological methods

Scientific relevance. Currently, two types of methods are used to evaluate the potency of diphtheria and tetanus toxoids: the gold standard, which involves administering toxins to immunised animals, and serological methods, which involve quantifying protective antibodies in the serum of immunised animals. International validation studies of serological methods for assessing the potency of diphtheria and tetanus toxoids have resulted in revisions to the relevant chapters of the WHO Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines, as well as the European, Japanese, and several other pharmacopoeias. Consequently, some diphtheria and tetanus vaccine manufacturers have substituted the potency evaluation methods that require administering toxins to animals with alternative serological methods.Aim. The study aimed to assess the suitability, reproducibility, and feasibility of an alternative enzyme immunoassay method (ELISA) for assessing the potency of diphtheria and tetanus components of diphtheria, tetanus, and whole-cell pertussis (DTwP) vaccines and to determine the possibility of implementing this method in Russia using standards and reagents manufactured in the country.Materials and methods. The study used combined vaccines for diphtheria prophylaxis, diphtheria toxin, and reference vaccines. The potency of diphtheria and tetanus toxoids was determined in guinea pigs and mice by the pharmacopoeial lethal challenge method and an alternative ELISA method.Results. ELISA and lethal challenge methods demonstrated comparable results of potency determination: 230 IU/mL vs 264 IU/mL (diphtheria toxoid), 188 IU/mL vs 160 IU/mL (tetanus toxoid), respectively. As opposed to the lethal challenge, the serological method allows testing the efficacy of several antigens in the same animals. The study showed the possibility of using purified diphtheria and tetanus toxoids manufactured in Russia as coating antigens. The authors obtained comparable antibody titres for each animal, using plates coated with international standards and Russian-made diphtheria and tetanus toxoids.Conclusions. The authors demonstrated the possibility of using ELISA to determine the potency of diphtheria and tetanus toxoids in DTwP vaccines. Moreover, the study demonstrated the suitability of Russian purified diphtheria and tetanus toxoids as coating antigens. Researchers should continue working on enzyme immunoassay validation with a view to harmonising national and international methods for assessing the potency of diphtheria and tetanus toxoid vaccines, as these efforts will not only facilitate the registration of foreign vaccines in Russia but also accelerate the approval of Russian vaccines in other countries.

Development of a novel drug information provision system for Kampo medicine using natural language processing technology

BackgroundKampo medicine is widely used in Japan; however, most physicians and pharmacists have insufficient knowledge and experience in it. Although a chatbot-style system using machine learning and natural language processing has been used in some clinical settings and proven useful, the system developed specifically for the Japanese language using this method has not been validated by research. The purpose of this study is to develop a novel drug information provision system for Kampo medicines using a natural language classifier® (NLC®) based on IBM Watson.MethodsThe target Kampo formulas were 33 formulas listed in the 17th revision of the Japanese Pharmacopoeia. The information included in the system comes from the package inserts of Kampo medicines, Manuals for Management of Individual Serious Adverse Drug Reactions, and data on off-label usage. The system developed in this study classifies questions about the drug information of Kampo formulas input by natural language into preset questions and outputs preset answers for the questions. The system uses morphological analysis, synonym conversion by thesaurus, and NLC®. We fine-tuned the information registered into NLC® and increased the thesaurus. To validate the system, 900 validation questions were provided by six pharmacists who were classified into high or low levels of knowledge and experience of Kampo medicines and three pharmacy students.ResultsThe precision, recall, and F-measure of the system performance were 0.986, 0.915, and 0.949, respectively. The results were stable even with differences in the amount of expertise of the question authors.ConclusionsWe developed a system using natural language classification that can give appropriate answers to most of the validation questions.

Identification of Anti-Inflammatory Compounds from Peucedanum praeruptorum Roots by Using Nitric Oxide-Producing Rat Hepatocytes Stimulated by Interleukin 1β.

The roots of Peucedanum praeruptorum Dunn and Angelica decursiva Franchet et Savatier are designated Zenko, which is a crude drug defined by the Japanese Pharmacopoeia. This crude drug is used as an antitussive and an expectorant and is included in the Kampo formula Jinsoin, which improves cough, fever, and headache. Although the anti-inflammatory effects of this crude drug have been determined, the constituents responsible for this effect remain unknown. To investigate biologically active compounds, rat hepatocytes were used, which produce proinflammatory mediator nitric oxide (NO) in response to proinflammatory cytokine interleukin 1β (IL-1β). A methanol extract of P. praeruptorum roots, which suppressed IL-1β-induced NO production, was fractionated into three crude fractions (ethyl acetate (EtOAc)-soluble, n-butanol-soluble, and water-soluble fractions) based on hydrophobicity. The EtOAc-soluble fraction markedly inhibited NO production. After this fraction was purified, three biologically active compounds were identified as praeruptorins A, B, and E, the contents of which were high. A comparison of their activities indicated that praeruptorin B exhibited the highest potency to inhibit NO production by decreasing inducible NO synthase expression and suppressed the expression of mRNAs encoding proinflammatory cytokines. Collectively, the three praeruptorins may primarily contribute to the anti-inflammatory effects of P. praeruptorum roots.

Genetic identification of the original plant species for Mentha Herb listed in the Japanese Pharmacopoeia and analyses of their essential oil composition

Mentha arvensis Linné var. piperascens Malinvaud is an original plant species for "Mentha Herb (Hakka, ハッカ)" and "Mentha Oil (Hakka-yu, ハッカ)" listed in the Japanese Pharmacopoeia, whereas Mentha canadensis L. is that of "Mint oil, partly dementholised" listed in the European Pharmacopoeia. Although these two species are thought to be taxonomically identical, there are no data on whether the source plants of the Mentha Herb products distributed in the Japanese market are actually M. canadensis L. This is an important issue for international harmonization of the Japanese Pharmacopoeia and European Pharmacopoeia. In this study, 43 Mentha Herb products collected from the Japanese market and two plant samples of the original species of Japanese Mentha Herb harvested in China were identified by sequence analyses of the rpl16 regions in the chloroplast DNA, and the composition of their ether extracts was analyzed by GC-MS. Almost all samples were identified as M. canadensis L., and the main component of their ether extracts was menthol, although there were variations in their composition. However, there were some samples thought to be derived from other Mentha species, even though their main component was menthol. For quality control of Mentha Herb, it is important to be sure of not only the original plant species but also the composition of the essential oil and amount of menthol as the characteristic compound.

Changes in Test Methods for Internationalization in the Japanese Pharmacopoeia (Part 3): Establishment of a Quantitative Method for Sodium Cromoglicate and Trihexyphenidyl Hydrochloride Using HPLC Analysis

The Japanese Pharmacopoeia (JP) is an official normative publication for establishing the authenticity and properties and maintaining the quality of pharmaceutical products in Japan. The JP is revised every five years and partially revised in order to respond to the progress of science and technology, the demand for medical care, and international harmonization. Thus, "Internationalization of the JP" is one of the most important issues to address for the revision of the JP, which is also referred to the basic principles for the preparation of the JP 19th edition. For instance, the incorporation of the test methods that have been used in other pharmacopeias, such as the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP), into the JP is one of promising approaches. From this perspective, we have recently reported changes in test methods, establishment of a quantitative test method for the JP-listed clonidine hydrochloride as well as lorazepam from using a potentiometric titration method to using HPLC method. As our ongoing study to change test methods for internationalization, we selected sodium cromoglicate and trihexyphenidyl hydrochloride. Each pharmaceutical product is analyzed using a potentiometric titration method as listed in the 18th JP; however, both the EP and the USP use HPLC method for quantitative analysis of these drugs. In this study, we synthesized the related impurities of sodium cromoglicate and trihexyphenidyl hydrochloride listed in the EP and determined their purities using quantitative NMR. The separation conditions of these compounds were examined using HPLC and simultaneous analyses were performed.

Review on Herbal Monograph Preparation

For instance, the British, Indian, and Japanese pharmacopoeias are manuals for the manufacture of high-quality medications that are released by a governing body or a concerned organisation. The therapeutic compendium and flavouring aggregation, however, are superior monographs on plant medicine (description of preparation on single topic). A compendium of knowledge is a pharmacopoeial work. on active pharmaceutical ingredients (API) or products (APP), including details on their solubility, impurity profiles, testing processes, and checks for contaminants. A book that discusses a botanical remedy and provides details essential for accurately recognising it may be referred to as a flavouring treatise. It provides the basic explanation, terminology, the amount used, and the ingredients, several application methods, contraindications, and an aspect. effects, medicine compatibility issues, dose, usage,, herb. For all individuals and organisations engaged in pharmaceutical analysis and development, manufacturing, and testing on a global scale, Aggregation is an essential resource. By developing standards of identity, purity, and analysis for botanicals as well as by reviewing both ancient and modern knowledge regarding their efficacy and safety, the flavouring association hopes to promote the responsible use of flavouring medicines with the highest possible degree of effectiveness and safety. The American Flavoring Association (AHP) and individuals from various nations (such as the United States Association, the European Association, the Association of the People's Republic of China, and the Indian Ayurvedic Pharmacopoeia) shall encourage the responsible use of flavouring the best feasible combination of safe and effective drugs, and to spread this knowledge. via means of monographs and other books. BP is currently used as a primary reference in more than 100 countries; the Yankee Flavoring Consortium (AHP) plans to offer 300 monographs on botanicals, including some of the Ayurvedic, Chinese, and Western herbs most frequently used in the USA; the Indian Flavoring Association (IHP) in its cover version covers 52 monographs on Indian meditative plants; and the African Flavoring Association (AHP) provides comprehensive and up to date botanic, commercial, and phytochemical information Many meditation plants employed in ancient Chinese culture have monographs in The People's Republic of China (PPRC, English ed. 2000). Some UN agency members don't have their own collection but instead adhere to one or more groups representing diverse states (e.g., in Australia, flavouring raw materials area unit needed to be attested to the relevant potential treatise within the British pharmacopoeia). The World Health Organization (WHO) has released 117 flavouring monographs since 1999 in four volumes, with the goal of promoting worldwide harmony in the internal management and use of flavouring medications as well as serving as templates for the creation of national formularies. in addition to a second volume (30 monographs, thirteen new and seventeen adopted from the present monographs). Each UN agency monograph contains a systematic description of facts regarding a small number of distinct medicinal plants or illicit substances on nineteen different themes, spanning from I Definition to (xvii) of different countries (e.g., in Australia, flavouring raw materials area unit needed to be attested to the relevant potential treatise within the British pharmacopoeia).Since 1999, 117 flavouring monographs have been released by the World Health Organization (WHO) in four volumes, along with 30 extra volumes that contain dosage forms, material medica, and references (xviii, xviii, xix). The flavouring aggregate consists of excellent and helpful botanical monographs. This comprehensive scientific reference list on the calibre, security, and efficacy of medicinal herbs is provided as a guide for flavouring discussions. The official compendia in the pharmacopoeia should not be considered to be a substitute for the UN agency monographs. Various plant parts, including as leaves, blossoms, fruit, seeds, stems, wood, bark, roots, rhizomes, ergot, shrubs, and flowers, are utilised as raw materials in organised medicine publications. In contrast, monographs on non-organic medicine list items like juices, gums, fixed oils, essential oils, latex, resins, fish liver oils, musk, beeswax, specific hormones, enzymes, and antitoxins in fresh or dry states, as well as other substances and blister beetles that can be whole, fragmented, or small-grained..