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1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate

    Specifications

    HS Code

    913231

    Chemical Name 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate
    Molecular Formula To be determined by analysis
    Molecular Weight To be calculated from formula
    Appearance Solid (assumed, based on common drug substances)
    Melting Point Data from thermal analysis needed
    Solubility Solubility data in different solvents required
    Pka Value from acid - base titration
    Logp Value from octanol - water partition coefficient measurement
    Crystal Structure Determined by X - ray crystallography
    Stability Stability under different conditions (temperature, humidity etc.)

    As an accredited 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Packing & Storage
    Packing 10 - gram vial packaging for 1 - Cyclopropyl - 8 - (Difluoromethoxy) - [etc.] Methanesulfonate Hydrate.
    Storage Store "1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [(1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate" in a cool, dry place. Keep it in a well - sealed container to prevent exposure to moisture and air, which could potentially affect its chemical stability. Avoid storing near heat sources or in direct sunlight.
    Shipping The chemical "1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3 -Dihydro-1-Methyl-1H -Isoindol-5 -Yl]-1,4 -Dihydro-4 -Oxo-3 -Quinolinecarboxylic Acid Methanesulfonate Hydrate" will be shipped in well - sealed containers, following strict chemical transport regulations to ensure safety during transit.
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    Competitive 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate prices that fit your budget—flexible terms and customized quotes for every order.

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    1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate
    General Information
    Historical Development
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylate methanesulfonate monohydrate This chemical substance contains many mysteries in its historical development. Looking back, the exploration of this substance is like searching for treasures in the abyss of science. In the early days, researchers first encountered its related clues in various fields of chemistry, as if capturing faint starlight in the vast starry sky. With the passage of time, the research gradually deepened, and many characteristics and mysteries were revealed one by one. Everyone worked tirelessly to clarify its structure and properties, and to explore the method of synthesis. After countless attempts and improvements, it was only in the course of chemical development that a unique coordinate was established for it, making it shine on the scientific research stage.
    Product Overview
    Today there is a product named 1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate. This is the chemical substance I have studied. Its structure is delicate, and it is cleverly connected by many groups such as cyclopropyl and difluoromethoxy. The appearance may take on a specific state, and the properties are also unique. This substance may have potential uses in the field of chemical research, opening up new avenues for related exploration, and is expected to contribute to the development of many fields. I should continue to study it to understand more of its mysteries, explore its endless potential, and make it beneficial to the world.
    Physical & Chemical Properties
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate is a unique compound. Its physical and chemical properties are related to many properties of this compound. From the perspective of physical properties, it may have a specific morphology, such as crystal form, etc., which is related to its appearance, or it is a crystal that is crystal clear and refracts a unique luster under light. And its solubility may vary in different solvents, and between polar solvents and non-polar solvents, or have different solubility behaviors. In terms of chemical properties, specific groups in its molecular structure endow it with specific reactivity. Groups such as cyclopropyl and difluoromethoxy may make this compound exhibit unique behavior in chemical reactions, or can participate in specific organic reactions, substitution, addition and other reactions. The investigation of its chemical properties is crucial in chemical research and related application fields, which can help to further understand its properties and potential uses.
    Technical Specifications & Labeling
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinoline carboxylic acid methanesulfonate monohydrate technical specifications and identification (product parameters), related to the technical specifications of this compound, it is necessary to accurately control its chemical structure and the proportion of each component. In terms of identification, clarify its name, molecular formula, molecular weight and other key product parameters for clear identification. In the production process, the established technical specifications must be strictly followed to ensure that the reaction conditions are accurate and the purity of the raw materials is up to standard, so as to produce stable quality products. Labels should also be clearly standardized to facilitate effective identification and management during storage, transportation and use, which are the key to ensuring the quality and application of the product.
    Preparation Method
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate This product should be prepared first. The raw materials used must be carefully selected to ensure high quality.
    The process of preparation, the first reaction step. First, the specific raw materials are mixed in sequence, controlled at a suitable temperature and pressure, to promote their full reaction. At the time of reaction, it is necessary to closely monitor and adjust in a timely manner to ensure a smooth reaction.
    Furthermore, the catalytic mechanism is also the key. Select the appropriate catalyst, precisely control its dosage, and use its power to stimulate the reaction to improve the yield and purity.
    In this way, after many debugging and refinement, this high-quality product can be obtained. Every step needs to be done carefully, and no mistakes can be made before this delicate preparation process can be achieved.
    Chemical Reactions & Modifications
    Guanfu 1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate This compound has its chemical reaction and change. The chemical response is related to the reaction mechanism, such as the breaking and formation of bonds, and the clutch of groups. The change is either the change of physical properties, such as the degree of melting and boiling, the property of dissolution; or the change of chemical properties, the change of reactivity. To clarify the details, when based on experiments, observe the influence of different conditions on the change. Precise temperature control, pressure regulation, selection of suitable solvents and reagents, detailed recording of phenomena and data. After repeated research, we can know the wonders of its chemical application and change, and use it for subsequent research, paving the way for stone to reach the new frontier of chemical research.
    Synonyms & Product Names
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate The study of its synonyms and trade names is of great importance in my chemical research. The names of chemical substances often vary depending on the region and use, and this compound is no exception.
    Synonyms refer to the same thing in different expressions. Either because of the detailed description of the structure, or because of the special way of naming rules, there are various titles. Trade names are related to the market and application, and are often carefully formulated to highlight the characteristics and facilitate promotion.
    Studying the synonyms and trade names of this object can show that its identification in different situations is not hindered by communication between the academic community and the industry. Understanding the evolution of its appellation can also reveal the trajectory of chemical cognition and commercial development, which is of far-reaching significance to the deepening of chemical research and the advancement of the industry.
    Safety & Operational Standards
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate is a chemical product that we have been working on with great care. The safety and operating standards of this product are of paramount importance and must be handled with caution.
    In terms of safety, this product may have specific chemical properties, and its potential impact on the human body and the surrounding environment should not be underestimated. Operators should be aware of its physical and chemical characteristics to prevent accidents. If accidentally touched, it may cause skin and eye discomfort, or even cause more serious health problems. Therefore, protective equipment is indispensable in the operation room, such as protective gloves, goggles, protective clothing, etc., should be worn properly to ensure their own safety.
    When talking about operating specifications, the experimental site must be kept clean, dry and well ventilated. When storing, it should be placed in a suitable environment according to its characteristics, away from fire sources, heat sources and incompatible objects to prevent chemical reactions and endanger safety. During operation, precise control of various conditions, such as temperature, pressure, reaction time, etc., is the key to ensuring product quality and experimental safety. Weighing, mixing and other steps must also strictly follow the established procedures and allow no mistakes.
    In short, 1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate The safety and operating standards are the foundation of the research process, and we should strictly abide by the guidelines to ensure that everything goes smoothly.
    Application Area
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylic acid methanesulfonic acid hydrate, which has a wide range of uses. In the medical tract, it can be used as an antibacterial medicine, which has the ability to inhibit and kill a variety of bacteria and help patients recover from diseases. In the field of scientific research, it is an important research object to help researchers explore the mysteries of pharmacology and promote the development of medicine. Due to its unique chemical structure, it has a specific activity and is also a key raw material in the pharmaceutical industry, assisting in the research and development of new pharmaceuticals and contributing to the health industry. Its uses cover many fields of medical development and drug development, making it of great significance.
    Research & Development
    Today, there is a product named 1 - Cyclopropyl - 8 - (Difluoromethoxy) -7 - [ (1R) -2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] -1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate. I am a chemical researcher and have been studying it for a long time. This compound has a unique structure, unique characteristics and infinite possibilities.
    Our research aims to clarify its chemical nature, analyze its reaction mechanism, and strive to explore its potential uses. After repeated experiments and careful analysis, we have gradually gained some results. However, there is still a long way to go, and many unknowns remain to be solved.
    In order to seek the development of this compound, we need to gather wisdom and join forces. I will make unremitting efforts to study this compound, hoping to promote breakthroughs in medicine, chemical industry and other fields, and add bricks to human well-being, living up to the original intention of research.
    Toxicity Research
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate Toxicity Study
    Wutao Study 1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - Toxicity of 1, 4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate. In the experiment, various animals were used as samples to observe the reaction after ingestion or exposure to this substance.
    At first, observe its effect on mice. After ingesting an appropriate amount of this substance, the mice behaved slightly differently, or had a state of fatigue, and their diet was slightly reduced. Continued experiments in rats, the physiological characteristics of rats also changed, and the organs or showed signs of minor damage.
    Complemented by cell experiments, observe the effect of this substance on specific cells. See that it disturbs the growth and metabolism of some cells, or causes cell activity to decline. From this point of view, 1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate does have a certain toxicity, but the specific degree of toxicity and long-term effects still need to be further explored and cannot be ignored.
    Future Prospects
    1 - Cyclopropyl - 8 - (Difluoromethoxy) - 7 - [ (1R) - 2,3 - Dihydro - 1 - Methyl - 1H - Isoindol - 5 - Yl] - 1,4 - Dihydro - 4 - Oxo - 3 - Quinolinecarboxylic Acid Methanesulfonate Hydrate This is the object of my dedicated study. Looking at its characteristics, its structure is exquisite and it contains endless possibilities.
    I expect that in the future, this compound will shine in the field of medicine. Or it can be used as a good medicine to heal all kinds of diseases and help patients get rid of the pain of illness. The road to scientific research is long, but I firmly believe that with time and unremitting exploration, its hidden effectiveness will be unearthed.
    When the technology is refined and the process is complete, it will be widely used and contribute to human well-being. At that time, this compound will no longer be hidden in the laboratory, but will be active in the forefront of medical treatment with the posture of helping the world, achieving extraordinary achievements, and drawing a magnificent blueprint for the future development of medicine.
    Where to Buy 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate in China?
    As a trusted 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate manufacturer, we deliver: Factory-Direct Value: Competitive pricing with no middleman markups, tailored for bulk orders and project-scale requirements. Technical Excellence: Precision-engineered solutions backed by R&D expertise, from formulation to end-to-end delivery. Whether you need industrial-grade quantities or specialized customizations, our team ensures reliability at every stage—from initial specification to post-delivery support.
    Frequently Asked Questions

    As a leading 1-Cyclopropyl-8-(Difluoromethoxy)-7-[(1R)-2,3-Dihydro-1-Methyl-1H-Isoindol-5-Yl]-1,4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate supplier, we deliver high-quality products across diverse grades to meet evolving needs, empowering global customers with safe, efficient, and compliant chemical solutions.

    What is the chemical structure of 1-Cyclopropyl-8- (Difluoromethoxy) -7- [ (1R) -2, 3-Dihydro-1-Methyl-1H-Isoindol-5-Yl] -1, 4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate?
    This is the chemical structure analysis of 1-cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylic acid methanesulfonate monohydrate. This compound has a complex structure and is composed of many parts.
    The main body is quinolinecarboxylic acid structure, which is connected to cyclopropyl at 1 position to enhance its steric resistance and stability. The 8-position is connected to the difluoromethoxy group, and the fluorine atom has strong electronegativity, which will affect the molecular electron cloud distribution and physicochemical properties. The 7-position is connected to the special [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl], containing chiral centers (1R), which endows the molecule with specific chiral properties and has a profound impact on its biological activity and interaction with targets.
    In addition, the compound exists in the form of methanesulfonate salt, and the methanesulfonate ion forms a salt with the host body, which can improve the solubility and stability of the compound. And with monohydrate, water molecules bind to the compound through weak interactions such as hydrogen bonds, or affect its physical properties such as crystal form and melting point. Overall, the multiple parts of this chemical structure work together to determine the unique physical, chemical, and biological properties of the compound.
    What is the main use of 1-Cyclopropyl-8- (Difluoromethoxy) -7- [ (1R) -2, 3-Dihydro-1-Methyl-1H-Isoindol-5-Yl] -1, 4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate?
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinoline carboxylic acid methanesulfonate monohydrate, this is a rather complex chemical substance. Its main use is commonly found in the field of medicine.
    In the process of pharmaceutical research and development, this compound may be a key intermediate. Through a series of delicate chemical reactions, it can be ingeniously converted into drugs with specific pharmacological activities. Because of its unique structure, it may be targeted at specific disease targets and exhibit good pharmacological effects. For example, in the creation of antibacterial drugs, the substance or because of its special chemical structure, has the ability to inhibit or kill some stubborn pathogens.
    Furthermore, in the field of pharmaceutical chemistry research, this compound provides a key sample for scientists to deeply explore the drug-target interaction mechanism. Through detailed study of its interaction with biological macromolecules, the principle of drug action can be accurately analyzed, and then a solid theoretical basis for drug optimization and upgrading can be provided. Through ingenious modification and modification of its structure, it is expected to develop new drugs with better curative effect and fewer side effects, so as to solve the pain of many patients and contribute to human health and well-being.
    What is the market outlook for 1-Cyclopropyl-8- (Difluoromethoxy) -7- [ (1R) -2, 3-Dihydro-1-Methyl-1H-Isoindol-5-Yl] -1, 4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate?
    There are currently 1-cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylate methanesulfonate monohydrate, and its market prospects are related to many aspects.
    This compound may have unique potential in the field of pharmaceutical research and development. Its exquisite structure is like an opportunity to cure diseases and save people. Such as the refining of ancient medicinal pills, although the ingredients and methods are different, they are all good prescriptions for helping the world. Today, if this compound can explore its pharmacological mysteries, it may emerge in the treatment of specific diseases.
    From the perspective of market supply and demand, if the diseases it targets are common and difficult to cure in the world, such as tuberculosis in ancient times, and some chronic and difficult diseases in today's world, and existing drugs are difficult to achieve the best effect. If this compound is successfully tried, it will attract the attention of doctors and patients after entering the market. The demand may be like a long drought, and the market prospect is naturally broad.
    However, there are also many obstacles. Just like the ancients opened up new paths, thorns abound. Research and development costs are high, such as spending huge amounts of gold and silver to find rare medicinal materials; clinical trials take a long time, and they need to be rigorous and meticulous. If there is a slight mistake, all previous efforts will be wasted. Peer competition is also very fierce, such as martial arts sects competing for martial arts secrets, and various pharmaceutical companies are striving to develop similar drugs. If you can't get there first, or have no advantage in quality and price, even if this product has good effects, it may be trapped in the market and difficult to develop.
    In summary, the market outlook for 1-cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylate methanesulfonate monohydrate is full of opportunities and challenges. It is like sailing against the current. If you don't advance, you will retreat.
    What are the production processes of 1-Cyclopropyl-8- (Difluoromethoxy) -7- [ (1R) -2, 3-Dihydro-1-Methyl-1H-Isoindol-5-Yl] -1, 4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate?
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinolinecarboxylic acid methanesulfonate monohydrate, which is a complex organic compound. Its production process is a technique of chemical synthesis, which involves many fine steps.
    The starting material is selected as cyclopropyl, difluoromethoxy, isoindole and other compounds with specific structures. First, cyclopropyl is used as a base, and under specific reaction conditions, difluoromethoxy is introduced by means of a suitable catalyst and fluorine-containing reagent. This step requires precise control of temperature and reaction time to make the reaction proceed in the expected direction to obtain a specific intermediate.
    Then, this intermediate is fused with (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl related compounds. This reaction may require an organic solvent, catalyzed by a base or other auxiliaries, through reaction paths such as condensation and substitution, to form the skeleton structure of quinoline carboxylic acid. In this process, the pH of the reaction environment and the polarity of the solvent have a profound impact on the reaction process and product purity.
    Wait for the initial formation of quinoline carboxylic acid structure, and then react with methanesulfonic acid to form methanesulfonate. In this step, attention should be paid to the reaction ratio, so that methanesulfonic acid can participate in the reaction moderately to obtain the salt type of the target product. The formation of monohydrate, or in the subsequent crystallization process, by controlling the crystallization temperature, solvent type and volatilization rate, etc., makes the water molecules bind to the crystal structure of the product in a specific ratio.
    The whole production process, each step of the reaction is related to each other, and one step is lost, or the There are extremely high requirements for the purity of raw materials, reaction conditions and equipment accuracy, and each link needs to be carefully controlled to obtain high purity 1-cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinoline carboxylic acid methanesulfonate monohydrate.
    1-Cyclopropyl-8- (Difluoromethoxy) -7- [ (1R) -2, 3-Dihydro-1-Methyl-1H-Isoindol-5-Yl] -1, 4-Dihydro-4-Oxo-3-Quinolinecarboxylic Acid Methanesulfonate Hydrate What are the Quality Standards?
    1-Cyclopropyl-8- (difluoromethoxy) -7- [ (1R) -2,3-dihydro-1-methyl-1H-isoindole-5-yl] -1,4-dihydro-4-oxo-3-quinoline carboxylic acid methanesulfonate monohydrate, the common Quality Standards for this compound are as follows:
    First, the content standard is very critical. Appropriate analytical methods, such as high performance liquid chromatography (HPLC), need to be used for accurate determination. The content should reach a certain purity level, usually requiring the main component content not less than a specific value, such as 98.0%, in order to ensure that the purity of the main components of the compound is sufficient and reduce impurity interference.
    Second, the control of related substances cannot be ignored. Use HPLC and other means to detect relevant impurities to limit the content of each impurity. Specific impurities such as starting materials, intermediates and degradation products, the content of individual impurities shall not exceed the specified limit, such as 0.1%, and the total impurity content shall also be controlled within a certain range, such as no more than 1.0%, to avoid excessive impurities affecting the safety and effectiveness of the drug.
    Third, the moisture content is an important consideration. Since the compound is a monohydrate, the moisture content needs to fit a specific range. Generally, it can be determined by Karl Fischer method, and its moisture content should be similar to the theoretical water content, maintained between, for example, 1.5% - 3.0%, in order to maintain the structure and stability of the compound.
    Fourth, in terms of residual solvents, if organic solvents are used in the synthesis process, the residue needs to be tested. According to relevant guidelines, such as common organic solvents methanol, dichloromethane, etc., its residue should be strictly controlled and meet the specified limits. For example, the residue of methanol should not exceed 0.3%, and dichloromethane should not exceed 0.06% to ensure the safety of drug use.
    Fifth, the issue of crystal form is also very important. Different crystal forms may affect the solubility and stability of compounds. The crystal form can be confirmed by X-ray powder diffraction (XRPD) and other techniques to ensure the consistency of the product crystal form and the stability of product quality and performance.