Sodium bicarbonate injection usp is a sterile nonpyrogenic, hypertonic solution of sodium bicarbonate in water for injection usp. All grades meet purity standards and particle size distribution requirements and are approved for the stated applications. Sodium bicarbonate, citric acid, sodium citrate and calcium. Close the carbon dioxide inlet and the system vent, and stir the saturated sodium bicarbonate solution until no further carbon dioxide absorption is noted from successive buret readings. Sodium bicarbonate 23jul2009 fwc76 processing nonagricultural ingredients and processing aids 01sep2019 not applicable. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single dose injection. Sodium bicarbonate, also known as baking soda, is a white or offwhite crystalline powder that functions as a buffer, an acid neutralizer, a source of carbon dioxide, and a mild. Sodium bicarbonate t ablets quantity of water, and heat in a water bath for 15 minutes. The sodium carbonate and the sodium bicarbonate each contained one half percent. Sodium bicarbonate injection usp is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate in water for injection. It has a slightly salty, alkaline taste resembling that of.
A 1 in 10 solution gives positive tests for sodium and for bicarbonate. Sodium bicarbonate for the treatment of lactic acidosis. Firstaid measures eyes in case of eye contact, rinse with plenty of water and seek medical attention if necessary. Protective effect of sodium bicarbonate on radiological contrast. Sodium bicarbonate elemental impurity statement genesis alkali is compliant with the usp elemental impurities chapter, which replaced the heavy metals test. Search results for sodium bicarbonate usp at sigmaaldrich. Procedure add 25 ml of saturated sodium bicarbonate solution to the 50ml flask, and flush the system by allowing humidified carbon dioxide to enter through the side arm. The influence of the buffering capacity on the production of organic. Sodium bicarbonate commonly known as baking soda or bicarbonate of soda, is a chemical compound with the formula nahco3. In cardiac arrest, a rapid intravenous dose of 200 to 300 mmol meq of bicarbonate, given as a 7. Sodium bicarbonate may be used as a buffering agent, combined with table salt, when creating a solution for nasal irrigation. It is a salt composed of a sodium cation and a bicarbonate anion. Labeling where sodium bicarbonate is intended for use in hemodialysis, it is so labeled. Heavy metals no usp requirement 5 ppm max as pb carbonate meets usp requirement no fcc requirement chloride as cl 150 ppm max no fcc requirement sulfur compounds 150 ppm max no fcc requirement identification responds to usp tests positive in fcc tests for for sodium and bicarbonate sodium and bicarbonate.
When smaller doses are required, the unused portion should be discarded. The purpose for the revision is to modify the test for limit of ammonia as follows. Sodium bicarbonate functions as a buffer, an acid neutralizer, a source of carbon dioxide, and a mild abrasive. Accidental release measures sweep up into clean, dry containers for salvage or disposal. Sodium bicarbonate usp about fagron fagrons strategy is focused on the optimization and innovation of pharmaceutical compounding. Sodium bicarbonate fda prescribing information, side. Sodium bicarbonate 144558 42 84 mgml carbon dioxide, nf 124389 as needed to adjust ph water for injection 7732185 q. Wear appropriate protective eyeglasses or chemical safety goggles as described by whmis or oshas eye and face protection regulations in 29 cfr 1910. North america download documentation for bicar usp grade 1. Monographssmall molecules 3 in accordance with the rules and procedures of the council of experts, the monographssmall molecules 3 expert committee intends to revise the sodium bicarbonate monograph. Chemical category chemical family chemical product. Dissolve the residue in 10 ml of 3 n hydrochloric acid, evaporate to dryness, and cool. Monensin, sodium bicarbonate and limestone sources in rations with high. First aid measures eye contact immediately flush eyes with plenty of cool water for at least 15 minutes.
It is a parenteral solution containing sodium chloride in water for injection intended for intravenous administration. Baking soda, bicarbonate of soda, sodium bicarbonate. Sodium bicarbonate eng presc info nonannotated osip 2020. A kit formulated under good manufacturing practices for labeling. Sodium bicarbonate is also used as an ingredient in some mouthwashes. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a singledose injection. Sodium bicarbonate injection, usp is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate nahco 3 in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer solutions are. This draft guidance, when finalized, will represent the. Page citations refer to the pages of volumes 7, 2, 3, and 4 of usp 37nf 32. Specification sodium bicarbonate grade 1 usp united. Sodium bicarbonate injection, usp is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.
Firstaid measures eye contact rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Sodium bicarbonate usp grade 5 is a white coarse granule that is stable in dry air but decomposes slowly in moist air. Sodium bicarbonate united states pharmacopeia usp reference standard. Sodium bicarbonate injection, usp is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydratin, extracorporeal circulation of blood, cardiac arrest and in the treatment of certain drug intoxications, including barbiturates where dissociation of the barbiturateprotein complex is desired, in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring. Sodium bicarbonate eng presc info nonannotated osip. Usp class 1 and class 2a elemental impurities in genesis sodium bicarbonate. Sodium bicarbonate injection, usp is administered by the intravenous route. Sodium bicarbonate feeding increased milk fat concentration 0. Sodium bicarbonate is also an essential ingredient in pharmaceuticals, health and beauty aids, water treatment and industrial applications.
Inhalation move casualty to fresh air and keep at rest. Sodium bicarbonate, powder, usp sds preparation date 10172016. Dissolve the residue in 5 ml of 3 n hydrochloric acid, evaporate to dryness, and cool. When the ventricle beats with normal frequency, the contractions. Sodium bicarbonate in combination with other ingredients can be used to make a dry or wet deodorant. Sodium bicarbonate, or baking soda, is an alkaline compound that produces carbon dioxide gas when combined with acid and causes batter to rise. Standards in usp 37 nf 32 are official and fdaenforceable for drugs.
Baking soda, a sodium bicarbonate, is a naturally occurring substance that is present in all living thingsit helps living things maintain the ph balance necessary for life. Bicarbonate not involved in that reaction is absorbed and in the absence of a deficit of bicarbonate in the plasma, bicarbonate ions are excreted in the urine, which is rendered alkaline, and there is an accompanying diuresis. The changes in testing are reported on certificates of analysis coa. Sodium bicarbonate, commonly known as baking soda or bicarbonate of soda, is a chemical compound with the formula nahco3. See table in how supplied section for contents and characteristics. Hemodynamic and metabolic effects in diabetic ketoacidosis in rats of treatment with sodium bicarbonate or a mixture of sodium bicarbonate and sodium carbonate. Packaging and storage preserve in wellclosed containers. Prescribing information sodium bicarbonate injection. Sodium bicarbonate united states pharmacopeia usp reference. In accordance with the rules and procedures of the council of experts, the monographssmall molecules 3 expert committee intends to revise the sodium bicarbonate monograph. Sodium bicarbonate injection, usp is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate nahco 3 in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Sodium bicarbonate injection, usp is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate nahco3 in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Sigmaaldrich offers a number of sodium bicarbonate products.
Sodium bicarbonate 23jul2009 fwc75 processing nonagricultural ingredients and processing aids 01sep2018 not applicable. Sodium bicarbonate safety data sheet page 1 of 3 section 1. These useful functions make sodium bicarbonate an essential ingredient in pharmaceuticals, overthecounter preparations, health and beauty aids, foods, water. Sodium bicarbonate injection usp is administered by the intravenous route and may be diluted in 0. Sodium bicarbonate 23jul2009 fwc73 processing nonagricultural ingredients and processing aids 01sep2018 not applicable. Sodium bicarbonate 23jul2009 fwc75 processing nonagricultural ingredients and processing aids 01sep2019 not applicable. Sodium bicarbonate for the treatment of lactic acidosis sean. After the sodium bicarbonate has dissolved, add 6 n sulfuric acid until the solution turns pink. C u concentration of sodium bicarbonate in the these standard solutions contain 2.
Sodium bicarbonate usp ingredient supplier bell chem. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated. Use this solution to fill the reservoir of the apparatus. Sodium bicarbonate twa 10 mgm3 solvay acceptable exposure limit particles not otherwise specified pnos national institute for occupational safety and health includes all inert or nuisance dusts, whether mineral, inorganic, not listed specifically in 1910.
By geometric addition, combine and mix, using a manual tumbler mixer do not. It is an excellent odor absorber and it provides carbonate alkalinity. It is a component of the mineral natron and is found dissolved in many mineral springs. It has a slightly alkaline taste and is insoluble in alcohol. D isplacement solution dissolve 100 g of sodium chloride in 350 ml of water, add about 1 g of sodium bicarbonate and 1 ml of methyl orange ts. Labeling where sodium bicarbonate is intended for use in hem dialysis, it is so labeled. Pyridoxine hydrochloride 37 mg, sodium chloride 61 mg oral. Combined index to usp 42 and nf 37, volumes 15, including. Sodium bicarbonate is used for the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. I4 ammonartic combined index to usp 41 and nf 36 ammonium continued analytical procedures for recombinant citrate phosphate dextrose adenine reineckate ts, 5751 therapeutic monoclonal antibodies. Formulated tablet was transferred to 150 ml of simulated gastric fluid sgf ph 1. Usp certificates and valid use dates for previous lots view harmonized system hs code.
Section 1 identification of the substancemixture and of the companyundertaking product identifier. Prescribing information sodium bicarbonate injection, usp. Natural sodas sodium bicarbonate is a pure, naturallyproduced product. In cardiac arrest, a rapid intravenous dose of one to two 50 ml vials 44. Skin flush with plenty of water and wash using soap.
Sodium bicarbonate should be used with extreme caution in patients with congestive heart failure or other edematous or sodium retaining conditions. Baking soda is made from soda ash, also known as sodium carbonate. Natural soda llc 3200 county road 31 rifle, colorado 81650 usa phone number. F 008 258 calcium citrate 285 magnesium citrate 6180 potassium. Insoluble substances usp dissolve 1 g in 20 ml of water. Prescribing information sodium bicarbonate injection usp. It has a slightly salty, alkaline taste resembling that of washing soda. To evaluate the renoprotective effect of sodium bicarbonate bic on renal function creatinine clearance clcr, jaffe. Personal precautions, protective equipment and emergency procedures. Sodium bicarbonate usp grade is a highly versatile ingredient, having applications across numerous industries. Sodium bicarbonate is a white solid that is crystalline, but often appears as a fine powder. In cardiac arrest, a rapid intravenous dose of one to two 50 ml syringes 44. Page citations refer to the pages of volumes 1, 2, 3, 4 and 5 of usp 42nf 37 and its.
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