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Alimta ® (pemetrexed for injection)
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Alimta (pemetrexed): Density, pH and other physical and chemical properties
Relevant physical and chemical characteristics of Alimta are provided, including osmolality, density, pH, and sensitivity to oxygen, moisture or light.
Product Characteristics
Alimta is a powder for concentrate for solution for infusion.1
Alimta is a white to either light yellow or green-yellow lyophilised powder.1
For precautions to be taken before handling or administering Alimta and for instructions on reconstitution and dilution of Alimta before administration, see summary of product characteristics section 6.6.1
Further relevant characteristics of Alimta is provided in Alimta Characteristics.
|
Details |
Osmolality |
The osmolality of Alimta 500 mg solution reconstituted with 20 mL 0.9 % sodium chloride at 25°C is 514 mOsm/kg of water |
Density |
The density of Alimta is approximately 1.02 g/mL at 25°C if Alimta is reconstituted with 0.9 % Sodium Chloride aqueous solution as directed |
pH |
The pH of Alimta is between 6.6 & 7.8 when reconstituted in 0.9 % Sodium Chloride Injection |
Oxygen |
Alimta (pemetrexed disodium) degrades by oxidation. Alimta is oxygen sensitive and exposure to air will affect the stability. The manufacturing process was developed to minimize oxidative degradation by reducing exposure of pemetrexed solution to oxygen and upon completion of lyophilization cycle the vacuum is neutralized with sterile filtered nitrogen thus controlling the oxygen level in the drug product vial headspace. |
Moisture |
Moisture does not impact the stability of intact vials of Alimta. (The lyophilized powder in the intact vials of Alimta contains residual moisture). |
Light sensitivity |
Alimta is not sensitive to light exposure. |
References
1Alimta [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 20 May 2021