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Methylpyrrolidone

Specializing in the production of pharmaceutical excipients

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Methylpyrrolidone

Name: Methylpyrrolidone

Other name: N-Methylpyrrolidone; NMP

NMPA CDE NO.: F20240000489

M.F.: C5H9NO

M.W.: 99.1

CAS No.: 872-50-4

Packaging: 0.5kg/bottle/carton; 1kg/bottle/carton; 5kg/bottle/carton

Appearance: Clear, colourless liquid, soluble in water and ethanol, miscible with alcohol, ether, ester, ketone, halogenated hydrocarbons and aromatic hydrocarbons

Quality Standard: USP, EP, BP

Application:

PreparationApplicationDosage
Ketoprofen gel patchAPI oil phase solvent0.5-2%
Precipitation type, lyotropic liquid crystal type in situ gelSolvent/Gel Inhibitor30%-70%
Oil injectionCo-solvent5-10%
Freeze-dried microsphere preparationOil phase solvent (process solvent)PLA:PEG-PLA:ethyl acetate:Methylpyrrolidone=3:1:20:25
Preparation of APIs and intermediatesReaction solvent

① Gel patch: about 1%, total solvent accounts for about 50%, most of which is water;

② In situ gel (sustained release injection): 30% NMP + 30% soybean phosphatidylcholine + 40% dioleylglycerol (lyotropic liquid crystal type); 55~70% NMP + 30~45% PLA/PLGA (precipitation type/solvent exchange type);

③ General injection grade: non-aqueous solvent miscible with water, used as a cosolvent. Intravenous injection is highly toxic and generally not applicable;

④ Process solvent: As a non-protonic cosolvent with low viscosity, good chemical and thermal stability, high polarity, low volatility, and infinite miscibility with a variety of solvents, it can be used as a reaction solvent for the synthesis of a variety of drugs and a process solvent for the preparation of a few poorly soluble API preparations.

Incompatibility: N-Methylpyrrolidone is non-reactive except in the presence of strong acids or bases. It can form complexes with metals, metal basic salts, and some active pharmaceutical ingredients, including benzocaine, phenol, and iodine. It is non-corrosive and biodegradable.

Storage: Protected from light(EP11.0); It is hygroscopic and sensitive to light. It is somewhat corrosive to copper, but not to other metals such as carbon steel and aluminum.