應(yīng)用
磺丁基倍他環(huán)糊精鈉是一種新型陰離子高水溶性環(huán)糊精衍生物,能很好地與藥物分子包合形成非共價(jià)復(fù)合物,從而提高藥物的穩(wěn)定性、水溶性、安全性,降低腎毒性、緩和藥物溶血性,控制藥物釋放速率,掩蓋不良?xì)馕兜取?/p>
目前已適用于注射藥、口服藥、鼻部用藥、眼部用藥,對(duì)于含氮類藥物具有特殊的親和力和包和性
技術(shù)指標(biāo)
磺丁基倍他環(huán)糊精鈉檢驗(yàn)標(biāo)準(zhǔn)
標(biāo)準(zhǔn)依據(jù):企業(yè)標(biāo)準(zhǔn)和USP-NF2024Enterprise Standard and USp-NF2024
項(xiàng)目
Item
指標(biāo)
Specification
外觀
Appearance
白色無(wú)定形粉末(CDE登記標(biāo)準(zhǔn))
白色或幾乎白色無(wú)定形粉末(USP)
White or almost white, amorphous or crystalline powder
溶解度
Solubility
易溶于水
Freely soluble in water
鑒別
IDENTIFICATION
紅外光譜
IR
樣品的紅外吸收?qǐng)D譜應(yīng)與對(duì)照品的紅外圖譜一致The infrared absorption spectrum is consistent with that of the Standard
HPLC
樣品液主峰的保留時(shí)間應(yīng)與標(biāo)準(zhǔn)液的保留時(shí)間一致
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution
平均取代度
Average Degree of Substitution
應(yīng)符合平均取代度的規(guī)定
Meets the requirements of the test for Average Degree of Substitution
鈉
Sodium
呈鈉鹽反應(yīng)
Gives the reactions of Sodium
澄清度
Clarity
應(yīng)澄清
The solution is clear, and essentially free from particles of foreign matter
含量
ASSAY (%)
95.0-105.0
重金屬
Heavy Metals (ppm)
≤5
倍他環(huán)糊精
Limit of Beta Cyclodextrin (Betadex) (%)
≤0.1
1,4-丁烷磺內(nèi)酯
Limit of 1,4-Butane Sultone(ppm)
≤0.5
氯化鈉
Limit of Sodium Chloride (%)
≤0.2
4-羥基丁烷-1-磺酸
Limit of 4-Hydroxybutane-1-sulfonic Acid (%)
≤0.09
雙(4-磺丁基)醚二鈉
Limit of and Bis(4-sulfobutyl) Ether Disodium (%)
≤0.05
細(xì)菌內(nèi)毒素
Bacterial Endotoxins (EU/mg)
<0.02
需氧菌總數(shù)
The total aerobic microbial (CFU/g)
≤100
霉菌和酵母菌
The total combined molds and yeasts (CFU/g)
≤50
取代度
6.2–6.9
大腸埃希菌
Escherichia coli
不得檢出
Absent
峰Peaks Ⅰ-Ⅹ
(%峰面積Peak Area)
Ⅰ
0.0-0.3
Ⅱ
0.0-0.9
Ⅲ
0.5-5.0
Ⅳ
2.0-10.0
Ⅴ
10.0-20.0
Ⅵ
15.0-25.0
Ⅶ
20.0-30.0
Ⅷ
10.0-25.0
Ⅸ
2.0-12.0
Ⅹ
0.0-4.0
pH
4.0-6.8
水分
Water Determination(%)
≤10
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