Assay methods for memantine

A technology of memantine and memantine hydrochloride, applied in chemical instruments and methods, measuring devices, preparation of organic compounds, etc., can solve problems such as obstacles and difficulties in derivatization

Inactive Publication Date: 2010-08-11
GENERICS UK LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Memantine also contains very few functional groups, which means that, in addition to the general disadvantages of the methods described above, derivatization to form compounds containing suitable chromophores or fluorophores will be di

Method used

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  • Assay methods for memantine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Embodiment 1: content uniformity test

[0080] GC system: Agilent 6890 or equivalent

[0081] Inlet sleeve: Agilent split / no split sleeve p / n 5183-4711

[0082] Column: ZB-1, 30m length, 0.32mm inner diameter, 1.0μm thin

[0083] film thickness

[0084] Precolumn: Deactivated fused silica tubing, 5m length, 0.32mm inner diameter

[0085] Carrier gas flow: Helium, 2.5mL / min (constant flow)

[0086] Inlet: Temperature: 340°C

[0087] Split injection: split ratio: 20:1

[0088] Gas Saver: On Time: 2.0 minutes

[0089] Flow: 20.0

[0090] Oven temperature: initial temperature 140°C

[0091] Start time 1 minute

[0092] Rate 1 10°C / min

[0093] Temperature 1 200°C

[0094] time 1 0 minutes

[0095] Rate 2 40°C / min

[0096] Temperature 2 340°C

[0097] time 2 1 minute

[0098] Detector: Flame Ionization Detector (FID) at 340°C

[009...

Embodiment 2

[0116] Embodiment 2: dissolution test

[0117] GC system: Agilent 6890 or equivalent

[0118] Inlet sleeve: Agilent split / no split sleeve p / n 5183-4711

[0119]Column: ZB-1, 30m length, 0.32mm inner diameter, 1.0μm thin

[0120] film thickness

[0121] Carrier gas flow: Helium, 2.5mL / min (constant flow)

[0122] Inlet: Temperature: 250°C

[0123] Split injection: split ratio: 10:1

[0124] Gas Saver: Off

[0125] Oven temperature: initial temperature 140°C

[0126] Start time 1 minute

[0127] Rate 1 10°C / min

[0128] Temperature 1 200°C

[0129] time 1 0 minutes

[0130] Rate 2 40°C / min

[0131] Temperature 2 300°C

[0132] time 2 2 minutes

[0133] Detector: Flame Ionization Detector (FID) at 300°C

[0134] Hydrogen 40mL / min

[0135] Air 400mL / min

[0136] Helium (refill) 22.5mL / min

[0137] Inject...

Embodiment 3

[0186] Embodiment 3: related substance test

[0187] GC system: Agilent 6890 or equivalent

[0188] Inlet sleeve: Agilent split / no split sleeve p / n 5183-4711

[0189] Column: ZB-1, 60m length, 0.32mm inner diameter, 1.0μm thin

[0190] film thickness

[0191] Carrier gas flow: Helium, 2.5mL / min (constant flow)

[0192] Inlet: Temperature: 250°C

[0193] Split injection: split ratio: 20:1

[0194] Gas Saver: On Time: 2.0 minutes

[0195] Flow: 20.0

[0196] Oven temperature: initial temperature 140°C

[0197] Start time 1 minute

[0198] Rate 1 2°C / min

[0199] Temperature 1 200°C

[0200] time 1 0 minutes

[0201] Rate 2 30°C / min

[0202] Temperature 2 300°C

[0203] time 2 5 minutes

[0204] Detector: Flame Ionization Detector (FID) at 250°C

[0205] Hydrogen 40mL / min

[0206] Air 400mL / min

...

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PUM

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Abstract

The present invention relates to a novel assay for the analysis of memantine and related compounds.

Description

technical field [0001] The present invention relates to a novel assay method for the analysis of memantine and related compounds. Background technique [0002] In order to guarantee marketing authorization of a medicinal product, the manufacturer must submit detailed evidence to the appropriate regulatory agency that the product is suitable for placing on the market. Regulatory agencies must be satisfied, inter alia, that the product is suitable for use in humans and that the particular pharmaceutical composition to be placed on the market is free from impurities and that it has acceptable storage stability (shelf life). [0003] Submissions to regulatory agencies must therefore include analytical data demonstrating that the active pharmaceutical ingredient (API) is free of impurities, or only negligible levels of impurities are present at the time of manufacture, and that the shelf life of the pharmaceutical composition is acceptable. [0004] Potential impurities in APIs ...

Claims

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Application Information

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IPC IPC(8): C07C209/84C07C211/38G01N30/88
CPCG01N30/06C07C2103/74G01N30/14C07C209/84G01N2030/025C07C2603/74C07C211/38
Inventor 林恩塞·约翰斯顿尼克·李卡塔里兹纳·沃伊塔赫尼奥-扎瓦达戴维·邓肯约翰·坎贝尔特蕾西·多伊尔
Owner GENERICS UK LTD
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