Edition: BP 2025 (Ph. Eur. 11.6 update)
Diazepam Injection
General Notices
Action and use
Benzodiazepine.
DEFINITION
Diazepam Injection is a sterile solution of Diazepam in Water for Injections or other suitable solvent. The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of diazepam, C16H13ClN2O
90.0 to 110.0% of the stated amount.
IDENTIFICATION
A. The light absorption, Appendix II B, of the solution obtained in the Assay exhibits a maximum at 368 nm. B. Complies with test B for Identification described under Diazepam Tablets applying separately to the plate 10 µL of each of the following solutions. For solution (1) dilute a suitable volume of the injection with sufficient methanol to produce a solution containing 0.10% w/v of Diazepam. Solution (2) contains 0.10% w/v of diazepam BPCRS in methanol.
TESTS
Acidity or alkalinity
pH, 6.2 to 7.0, Appendix V L.
ASSAY
To a volume containing 10 mg of Diazepam add 20 mL of mixed phosphate buffer pH 7.0 and extract with four 20 mL quantities of chloroform, passing each extract through the same 5 g of anhydrous sodium sulfate. Combine the chloroform extracts, dilute to 100 mL with chloroform and mix. Evaporate 10 mL to dryness in a current of nitrogen, dissolve the residue in 25 mL of 0.05M methanolic sulfuric acid, mix and measure the absorbance of the resulting solution at the maximum at 368 nm, Appendix II B. Calculate the content of C16H13ClN2O taking 151 as the value of A(1%, 1 cm) at the maximum at 368 nm.
STORAGE
Diazepam Injection should be protected from light.
