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Sodium Bicarbonate Excipients Bicart Hemodialysis for Russia and Central Aisa¹

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Product Description Sodium Bicarbonate BP USP GradeProduct Description Sodium Bicarbonate or a mixture of Sodium bicarbonate and lactate is currently a relatively ideal buffer. It is more in line with human physiology, has better biocompatibility, can avoid the adverse reactions caused by lactate as a buffer, and causes less infusion pain.In the past, due to the precipitation problems of calcium carbonate or magnesium carbonate, bicarbonate failed to be used as a buffer for peritoneal dialysis fluid. However, by using the double-chamber bag system and rapidly mixing the Sodium bicarbonate in the buffer chamber with the divalent cations in the glucose chamber at the time of use, this problem has been solved. Sodium bicarbonate is also used as antacid for the treatment of metabolic acidosis and alkalization of urine. It can also be used as antacid to treat symptoms caused by excessive gastric acid. The Advantages of Product Excellent qualityStrict quality standard and low impurity limit. The particles are full and smooth, and the particle size distribution is uniform.Advanced equipmentWith the adoption of new patented equipment, fully automated production and operation are realized, with high efficiency, stable output and distinct product particles.Complete categoriesOvercoming the technical barrier of large granular sodium bicarbonate, A P I, reagents and excipients can be supplied at three levels, which are suitable for oral administration, injection, hemodialysis and other fields. Detailed Photos Product Parameters CharacteristicUnitEPEnterprise Quality StandardDescription/ Appearance This product is white or white-like crystalline powder. It is white crystalline powder; Odorless. It gradually becomes sodium bicarbonate when left standing in damp air, and the alkalinity of the aqueous solution increases when left dry or heated in solution for a little longer, either by shaking or by heating.Solubility Soluble in water, practically insoluble in ethanol(96%)Soluble in water, insoluble in ethanolSodium salt Comply with the regulationComply with the regulationBicarbonate Positive reactionPositive reactionBasicity pH≤8.6pH≤8.6Clarity of solution Should be clear and colorlessShould be clear (for injection, hemodialysis) or no thicker than No.2 turbidity standard solution (for oral use)Chloridate Not thicker(0.015%)Not thicker[(0.002%(for injection, hemodialysis) or 0.015% (for oral use)]Sulphate Not thicker(0.015%)Not thicker[(0.005%(for injection, hemodialysis) or 0.015% (for oral use)]Ammonium salt No deeper(0.002%)No deeper(0.002%)Loss on drying ≤0.25%≤0.23%Elemental impurity -Al≤0.0002%;Cu≤0.0001%;Mg≤0.0002%Calcium salt ≤0.01%Not thicker[(0.01%(for injection, hemodialysis)]Molysite ≤0.002%Not thicker[(0.0005%(for injection, hemodialysis) or 0.0015%(for oral use)]Heavy metal PPM-≤5Arsenic salt -Comply with the regulation Bacterial endotoxin -<20EU/gMicrobial limit Total aerobic microbial count≤800cfu/g, Total yeasts and molds≤80cfu/g, Escherichia coli should not be detected (for oral use) Total aerobic microbial count≤80cfu/g, Total yeasts and molds≤10cfu/g, Escherichia coli should not be detected (for injection)Content NaHCO3 content should be 99.5 - 100.5% NaHCO3 content should be 99.0% - 101.0% (for injection, hemodialysis) or no more than 99.0% (for oral use) Packaging & ShippingPacked in PP bags as 25kg or depend on customer requirementStrictly Deliver the goods in accodance with the contract.Stored in a cool, ventilated warehouse. Keep away from fire and heat. Should be stored with acids, etc., Mixed storage is forbidden. The reservoir shall be provided with suitable materials for the leakage. Loading should be safe. During transportation;During transportation, it can not be exposed to insolation, rain, high temperature. Company ProfileWeifang Xinchang Chemical Co., Ltd, a limited liability company which is engaged in production and trade in accordance with modern enterprise management system.Main BusinessThe products mainly operated by the company include bulk chemicals such as sodium bicarbonate, cyclodextrin series (such as sodium sulfobutyl ether beta-cyclodextrin, hydroxypropyl beta-cyclodextrin, etc.), excipients and intermediates.Among them, the sodium bicarbonate product is produced by using the new patented equipment independently developed by the company, which has successfully overcome the technical barriers for large-particle sodium bicarbonate. The product is divided into two grades, namely bulk chemical grade and excipient grade, and is widely applicable to various medical fields such as oral administration, injection, and hemodialysis.Competitive ProductsSodium bicarbonate: Produced by using new patented equipment, it is of excellent quality and is divided into bulk chemical grade and excipient grade. It can be used for oral administration, injection and hemodialysis, meeting various medical needs.Sodium sulfobutyl ether beta-cyclodextrin: It is the first product registered as a excipient in China, filling the gap in the domestic market. Its registration number for excipients on the CDE (Center for Drug Evaluation) platform is F20180000620, and its registration number for filing with the US FDA (Food and Drug Administration) is DMF 29394, reaching an international leading level.Hydroxypropyl beta-cyclodextrin: The product has multiple specifications and uses and has been widely used and recognized in both domestic and foreign markets. Its registration numbers for excipients on the CDE platform include F20209990335 (for oral administration, Status A, Approval Number of Shandong Products: F2012004), F20180000146 (for oral administration), F20180000895 (for injection), and its registration number for filing with the US FDA is DMF 033403.Customized R&D and Sales SupportThe company has a professional R&D team that can undertake customized R&D projects for intermediates to meet the individualized needs of customers. Meanwhile, the company also has an experienced sales team and a technical support department that can provide customers with all-round and high-efficiency services. FAQ Q: Are you a trade company or factory? A: We are a chemical factory with our own trading company.Q: How long time you can make the shipping? A: We can make the shipping within 15 days after confirming the order. Q: Where is your factory located? How can I visit the factory? A: Our factory located in WEIFANG, China. It is only two hours from QINGDAO.

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