Method for the quantitative determination of poloxamers
A poloxamer, quantitative determination technology, applied in the field of liquid protein samples, can solve quantitative detection and other problems
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Embodiment 1
[0208] Embodiment 1 (with reference to accompanying drawing 1)
[0209] The purpose of this example is to analyze the commercially available liquid hCG preparation Ovitrelle TM The concentration of Poloxamer 188 in its samples after 18 months storage at room temperature, and thus the stability of the liquid formulation was evaluated with respect to Poloxamer 188. Poloxamer 188 was prepared at a concentration of approximately 100 mcg / ml. Ovitrelle TM The quantitative detection scheme of poloxamer 188 is as follows:
[0210] Liquid Injectable Ovitrelle TM Contains the following ingredients: Chorionic Gonadotropin Alpha, Mannitol, L-Methionine, Poloxamer 188, Phosphoric Acid, NaOH and Water.
[0211] 1. Equipment and materials
[0212] supplier
[0213] HPLC ALLIANCE Model 269 Waters (Waters)
[0214] RI Detector Model 2414 Waters
[0215] Software Empower Waters
[0216] Personal computer IBM (or equivalent
[0217] ...
Embodiment 2
[0281] The purpose of this example is to analyze the commercially available liquid hFSH preparation Gonal-F RFF Pen TM Poloxamer 188 concentrations in their samples after 18 months storage at room temperature, and thus the stability of the liquid formulations was assessed with respect to Poloxamer 188. Poloxamer 188 was prepared at a concentration of approximately 100 mcg / ml. In addition to the column flow rate of 0.75ml / min, Gonal-F RFF Pen TM The quantification protocol for poloxamer 188 was the same as shown in Example 1 for Ovitrelle.
[0282] Poloxamers can be separated from hFSH and quantified separately.
Embodiment 3
[0284] The purpose of this example is to analyze the commercially available liquid hGH preparation Serostim TM Poloxamer 188 concentration in samples. Scheme is identical with embodiment 2.
[0285] Poloxamers can be separated from hGH and quantified separately.
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