STARTING MATERIAL FOR BULK DRUG OR ADDITIVES FOR DRUG, AND BULK DRUG OR DRUG USING SAME

摘要

The present invention provides a raw material for bulk drugs and a pharmaceutical additive which provide excellent formulation stability and excellent over-time stability of drug efficacy when used to modify a bulk drug, a polypeptide, a bioactive protein, an enzyme, and the like. The present invention relates to a raw material for bulk drugs or a pharmaceutical additive, containing: a polyether composition (A) represented by formula (1), wherein the polyether composition (A) has a unimodal molecular weight distribution, the polyether composition (A) has a ratio (Mw/Mn) of the weight average molecular weight (Mw) to the number average molecular weight (Mn) of 1.20 or less, and the polyether composition (A) contains a compound in which m is 1 in formula (1) in an amount of 90 wt% or more based on the weight of the polyether composition (A), in formula (1), OR1, R2O, R3O, and R4O are each independently a C2-C8 oxyalkylene group; when each of these moieties exists in the plural number, each OR1, each R2O, each R3O, and each R4O may be the same as or different from each other; these moieties may be bonded randomly or in block; a, b, c, and d are each independently an integer of 50 to 1200; X1to X4are each independently a hydrogen atom, a substituent represented by formula (2), or a substituent represented by formula (3); and m is an integer of 1 to 10.