Edition: BP 2025 (Ph. Eur. 11.6 update)
DEFINITION
| Sodium Bicarbonate | 5 g |
| Glycerol | 30 mL |
| Purified Water, freshly boiled and cooled | Sufficient to produce 100 mL |
Extemporaneous preparation
The following directions apply.
Dissolve the Sodium Bicarbonate in about 60 mL of Purified Water, add the Glycerol and sufficient Purified Water to produce 100 mL and mix.
Sodium Bicarbonate Ear Drops should be recently prepared.
The ear drops comply with the requirements stated under Ear Preparations and with the following requirements.
Content of sodium bicarbonate, NaHCO3
4.75 to 5.25% w/v.
Weight per mL
1.10 to 1.12 g, Appendix V G.
ASSAY
To 5 mL add 20 mL of water and titrate with 0.1M hydrochloric acid VS using methyl orange-xylene cyanol FF solution as indicator. Each mL of 0.1M hydrochloric acid VS is equivalent to 8.401 mg of NaHCO3.
