Vinorelbine Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Vinorelbine Injection is a sterile solution of Vinorelbine Tartrate in Water for Injection. It contains NLT 90.0% and NMT 110.0% of the labeled amount of vinorelbine (C₄₅H₅₄N₄O₈).

[CAUTION-Handle Vinorelbine Injection with great care because it is a potent cytotoxic agent.]

2 IDENTIFICATION

A. The retention time and UV spectrum of the major peak of the Sample solution correspond to those of the Standard solution, as obtained in the Assay.

3 ASSAY

Change to read:

PROCEDURE

Buffer: Dissolve 6.9 g of monobasic sodium phosphate in 900 mL of water. Adjust with phosphoric acid to a pH of 4.2, and dilute with water to 1000 mL.

Mobile phase: Dissolve 1.22 g of sodium 1-decanesulfonate in 620 mL of methanol, and add 380 mL of Buffer.

System suitability solution: Prepare a solution containing 1.4 mg/mL of USP Vinorelbine Tartrate RS and 0.01 mg/mL of USP Vinorelbine Related Compound A RS in water. Expose a portion of this solution in a suitable xenon lamp apparatus capable of supplying a dose of 1600 KJ/m² between 310 and 800 nm at a power of 500 W/m² for 1 h to generate an additional photodegradation product, 3,6-epoxy vinorelbine.

Standard solution: 0.14 mg/mL of USP Vinorelbine Tartrate RS in water

Sample solution: Nominally equivalent to 0.1 mg/mL of vinorelbine in water, from Injection

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: Diode array

Column: 3.9-mm x 15-cm; packing L1

Column temperature: 40°

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-The relative retention times for 3,6-epoxy vinorelbine, vinorelbine, and vinorelbine related compound A are 0.8, 1.0, and 1.2, respectively.]

Suitability requirements

Resolution: NLT 1.5 between vinorelbine and vinorelbine related compound A, System suitability solution

Relative standard deviation: ^▲NMT_{▲(ERR 1-Nov-2018)} 2.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of vinorelbine (C₄₅H₅₄N₄O₈) in the portion of Injection taken:

                         Result = (r_U/r_S) × (C_S/C_U) × (M_r1/M_r2) × 100

r_U = peak response from the Sample solution at 267 nm

r_S = peak response from the Standard solution at 267 nm

C_S = concentration of USP Vinorelbine Tartrate RS in the Standard solution (mg/mL)

C_U = nominal concentration of vinorelbine in the Sample solution (mg/mL)

M_r1 = molecular weight of vinorelbine, 778.93

M_r2 = molecular weight of vinorelbine tartrate, 1079.11 

Acceptance criteria: 90.0%-110.0%

4 IMPURITIES

ORGANIC IMPURITIES

Mobile phase and System suitability solution: Proceed as directed in the Assay.

Sample solution: Nominally equivalent to 1.0 mg/mL of vinorelbine in Mobile phase, from Injection

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 267 nm

Column: 3.9-mm x 15-cm; packing L1

Column temperature: 40°

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: System suitability solution

Suitability requirements

Resolution: NLT 1.5 between vinorelbine and vinorelbine related compound A

Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Injection taken:

                         Result = (r_U/r_T) x 100

r_U = peak response of each impurity from the Sample solution

r_T = sum of all the peak responses from the Sample solution

Acceptance criteria: See Table 1. Disregard any peaks less than 0.1%.

Table 1
 

^a 3',4',7,8-Tetradehydro-3,4'-dideoxy-3,6-epoxy-6,7-dihydro-8'-norvincaleukoblastine.

^b 4-0-Deacetylvinorelbine.

5 SPECIFIC TESTS

5.1 CLARITY OF SOLUTION

Sample solution: 10 mg/mL

Acceptance criteria: The solution is clear.

5.2 COLOR OF SOLUTION

Sample solution: 10 mg/mL

Analysis: Determine the absorbance of the Sample solution in a 1-cm cell at 420 nm in a suitable spectrophotometer, using water as the blank.

Acceptance criteria: NMT 0.060

5.3 BACTERIAL ENDOTOXINS TEST (85)

It contains NMT 3.0 USP Endotoxin Units/mg of vinorelbine.

5.4 STERILITY TESTS (71)

Meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined. Membrane Filtration

5.5 pH (791)

3.3-3.8

5.6 PARTICULATE MATTER IN INJECTIONS (788)

Meets the requirements for small-volume injections

5.7 OTHER REQUIREMENTS

It meets the requirements in Injections and Implanted Drug Products (1),

6 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in single dose containers as described in Packaging and Storage Requirements (659), preferably of Type I glass, protected from light. Store in a refrigerator.

USP REFERENCE STANDARDS (11)

USP Vinorelbine Related Compound A.RS

4-0-Deacetylvinorelbine tartrate.

C₄₃H₅₂N₄O₇ · 2C₄H₆O₆               1037.07

USP Vinorelbine Tartrate RS