» Vinorelbine Injection is a sterile solution of Vinorelbine Tartrate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of vinorelbine (C45H54N4O8).
[CautionHandle Vinorelbine Injection with great care because it is a potent cytotoxic agent. ]
Packaging and storage Preserve in single-dose Containers for Injections as described under Injections 1, preferably of Type I glass, protected from light. Store in a refrigerator.
USP Reference standards 11
USP Endotoxin RS
Clarity and color of solution The solution of Injection (10 mg per mL) is clear. The absorbance of a solution of Injection, determined in a 1-cm cell at 420 nm, with a suitable spectrophotometer, using water as the blank, is not greater than 0.060.
Identification The retention time and the UV spectrum of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85 It contains not more than 3.0 USP Endotoxin units per mg of vinorelbine.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 3.3 and 3.8.
Particulate matter 788: meets the requirements for small-volume injections.
Mobile phase and System suitability solution Proceed as directed in the Assay under Vinorelbine Tartrate.
Standard solution and Diluted standard solution Proceed as directed in the test for Related compounds under Vinorelbine Tartrate.
Chromatographic system Proceed as directed in the Assay.
Test solution Dilute a portion of Injection with Mobile phase to obtain a solution containing 1.0 mg of vinorelbine per mL.
Procedure Proceed as directed for Procedure in the test for Related compounds under Vinorelbine Tartrate. Not more than 1.0% of the photodegradation product is found; not more than 0.3% of vinorelbine related compound A is found; not more than 0.2% of any other individual impurity is found; and the sum of all impurities, excluding any peaks that are below the limit of quantitation (0.02%), is not more than 2.0%.
Other requirements It meets the requirements under Injections 1.
Phosphate buffer, Mobile phase, and System suitability solution Proceed as directed in the Assay under Vinorelbine Tartrate.
Standard preparation Dissolve an accurately weighed quantity of USP Vinorelbine Tartrate RS in water to obtain a solution having a known concentration of about 0.14 mg per mL.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 10 mg of vinorelbine, to a 100-mL volumetric flask, dilute with water to volume, and mix.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a diode-array detector and a 3.9-mm × 15-cm column that contains packing L1. The column temperature is maintained at 40. The flow rate is about 1.0 mL per minute. Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention, r, between vinorelbine tartrate and vinorelbine related compound A is not less than 1.1. [noteFor peak identification purposes, the relative retention times are about 0.8 for the photodegradation product, 1.0 for vinorelbine, and 1.2 for vinorelbine related compound A. ]
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the vinorelbine peaks, using a diode-array detector. Calculate the quantity, in mg, of vinorelbine (C45H54N4O8) in each mL of the Injection taken by the formula:
(778.93/1079.11)C(L/D)(rU / rS)in which 778.93 and 1079.11 are the molecular weights of vinorelbine and vinorelbine tartrate, respectively; C is the concentration, in mg per mL, of USP Vinorelbine Tartrate RS in the Standard preparation; L is the labeled quantity, in mg, of vinorelbine in each mL of Injection taken; D is the concentration, in mg per mL, of vinorelbine in the Assay preparation; and rU and rS are the peak responses at 267 nm obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 5028Pharmacopeial Forum: Volume No. 32(5) Page 1471