- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Sodium Bicarbonate Oral Solution |
note: Sodium Bicarbonate Oral Solution is not currently licensed in the United Kingdom.
Antacid; treatment of uraemic acidosis and renal tubular acidosis.
Sodium Bicarbonate Oral Solution is a solution containing Sodium Bicarbonate in Purified Water. It is supplied as a ready-to-use solution or it is prepared by dissolving Sodium Bicarbonate Powder for Oral Solution in the requisite volume of Purified Water just before issue for use.
The oral solution complies with the requirements stated under Oral Liquids, and with the requirements stated under Unlicensed Medicines.
The oral solution should be stored at the temperature and used within the period stated on the label.
When supplied as a ready-to-use solution, the oral solution complies with the following requirements.
95.0 to 105.0% of the stated amount.
A. The residue on evaporation, when moistened with hydrochloric acid and introduced on a platinum wire into a flame, imparts a yellow colour to the flame.
B. Yields reaction A characteristic of sodium salts and the reactions characteristic of bicarbonates, Appendix VI.
pH, 7.0 to 8.5, Appendix V L.
Titrate a volume containing 1 g of Sodium Bicarbonate with 0.5m hydrochloric acid VS using methyl orange solution as indicator. Each mL of 0.5m hydrochloric acid VS is equivalent to 42.00 mg of NaHCO3.
Sodium Bicarbonate Powder for Oral Solution is a dry powder consisting of Sodium Bicarbonate with or without excipients. It is supplied in a sealed container.
The dry ingredients comply with the requirements for Powders and Granules for Oral Solutions and Oral Suspensions stated under Oral Liquids and with the following requirements.
95.0 to 105.0% of the stated amount.
A. When moistened with hydrochloric acid and introduced on a platinum wire into a flame, imparts a yellow colour to the flame.
B. Yield reaction A characteristic of sodium salts and the reactions characteristic of bicarbonates, Appendix VI.
pH of a solution containing 5% w/v of Sodium Bicarbonate, 7.0 to 8.5, Appendix V L.
Dissolve a quantity of the contents of the sealed container containing 1 g of Sodium Bicarbonate in 50 mL of carbon-dioxide free water and titrate with 0.5m hydrochloric acid VS using methyl orange solution as indicator. Each mL of 0.5m hydrochloric acid VS is equivalent to 42.00 mg of NaHCO3.
When Sodium Bicarbonate Oral Solution for paediatric or neonatal use is prescribed or demanded, a solution containing 1 mmol/mL shall be dispensed or supplied.