 |
 |
 |
 |
 |
 |
||
 |
 |
 |
 |
 |
小木蟲論壇-學術科研互動平臺 » 生物醫(yī)藥區(qū) » 新藥研發(fā) » 立項調研 » 質量標準求助
| 5 | 1/1 | 返回列表 |
| 查看: 865 | 回復: 5 | ||
| 當前只顯示滿足指定條件的回帖，點擊這里查看本話題的所有回帖 | ||
[求助]
質量標準求助 已有2人參與
|
||
| 碘海醇注射液的質量標準 Iohexol Injection, BP 、EP |
回復此樓» 猜你喜歡
【招聘】清華大學藥學院錢鋒教授課題組誠聘博士后
已經有1人回復
-
新版scifinder
已經有1人回復
-
藥物學論文潤色/翻譯怎么收費?
已經有82人回復
-
安捷倫液相色譜柱與方法開發(fā)指南
已經有4人回復
-
2026申請考核博士自薦-蛋白質組學/AI/藥物設計/AIDD/化學生物學
已經有1人回復
-
中國醫(yī)藥行業(yè)發(fā)展現(xiàn)狀：標準品推動藥品檢測水平提升
已經有1人回復
» 本主題相關價值貼推薦，對您同樣有幫助:
- 質量標準的建立
已經有3人回復
- 質量標準建立設計方案
已經有3人回復
- 原研產品相關質量標準信息怎么查詢啊？
已經有6人回復
- 阿立哌唑國外質量標準
已經有11人回復
- 求助凝膠劑質量檢測標準
已經有3人回復
- 求助原研藥品說明書及質量標準
已經有4人回復
- 求助各位一個關于質量標準中有關物質的問題
已經有19人回復
- 卵磷脂質量的國際標準
已經有7人回復
- 化工原料的質量標準
已經有5人回復
- 藥典質量標準翻譯
已經有4人回復
- 塞來昔布原料質量標準
已經有123人回復
- 求助關于質量標準有關物質問題
已經有15人回復
- 【求助】關于質量標準研究中液相色譜峰對稱性問題
已經有16人回復
- 【求助】卵磷脂的質量標準
已經有3人回復
- 【交流】國家藥典中的質量標準是怎么建立起來的？
已經有18人回復
- 【求助】US EPA 制定的土壤重金屬的環(huán)境質量標準
已經有10人回復
mxx7456
新蟲 (小有名氣)
- 應助: 22 (小學生)
- 金幣: 836.9
- 帖子: 113
- 在線: 37.5小時
- 蟲號: 671698
- 注冊: 2008-12-10
- 性別: MM
- 專業(yè): 中藥質量評價
4樓2015-05-18 17:18:02
xdx1984
木蟲 (正式寫手)
- 應助: 22 (小學生)
- 金幣: 3721.7
- 紅花: 12
- 帖子: 471
- 在線: 195.2小時
- 蟲號: 847461
- 注冊: 2009-09-14
- 性別: GG
- 專業(yè): 藥物分析
2樓2015-05-18 13:54:22
【答案】應助回帖
★ ★
感謝參與，應助指數(shù) +1
mm1988: 金幣+2, ★★★很有幫助, USP38這是在哪里找的，美國藥典論壇嗎？如果是能不能教教我怎么查，注冊了賬號不會查，好慚愧 2015-05-19 09:41:22
感謝參與，應助指數(shù) +1
mm1988: 金幣+2, ★★★很有幫助, USP38這是在哪里找的，美國藥典論壇嗎？如果是能不能教教我怎么查，注冊了賬號不會查，好慚愧 2015-05-19 09:41:22
|
USP38 Iohexol Injection DEFINITION Iohexol Injection is a sterile solution of Iohexol in Water for Injection. It contains NLT 95.0% and NMT 105.0% of the labeled amount of iohexol (C19H26I3N3O9) as organically bound iodine. It may contain small amounts of suitable buffers and Edetate Calcium Disodium as a stabilizer. Iohexol Injection intended for intravascular or intrathecal use contains no antimicrobial agents. IDENTIFICATION • A. The retention times of the major peaks of the Sample solution correspond to those of the System suitability solution, as obtained in the test for Organic Impurities. ASSAY • Procedure Sample: A volume of Injection equivalent to 300 mg of iodine Analysis: Transfer the Sample to a glass-stoppered, 250-mL conical flask. Add 25 mL of 1.25 N sodium hydroxide and 500 mg of powdered zinc, connect the flask to a reflux condenser, and reflux the solution for 1 h. Cool the flask to room temperature, rinse the condenser with 20 mL of water, disconnect the flask from the condenser, and filter the mixture. Rinse the flask and the filter thoroughly with small portions of water, adding the rinsings to the filtrate. Add 5 mL of glacial acetic acid, and titrate with 0.1 N silver nitrate VS. Each mL of 0.1 N silver nitrate is equivalent to 27.37 mg of C19H26I3N3O9. Acceptance criteria: 95.0%–105.0% IMPURITIES • Organic Impurities Solution A: Acetonitrile Solution B: Water Mobile phase: The percentage of Solution A increases from 1% to 13% at a rate of 0.2%/min. System suitability solution: 1.5 mg/mL, 0.0075 mg/mL, and 0.0069 mg/mL each of USP Iohexol RS, USP Iohexol Related Compound A RS, and USP Iohexol Related Compound C RS in water Sample solution: 1.5 mg/mL of Iohexol Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 254 nm Column: 4.6-mm × 25-cm stainless steel column; packing L1 Flow rate: 1.0 mL/min Injection volume: 10 µL System suitability Sample: System suitability solution [Note—The relative retention times for the exo-isomer of iohexol and the O-alkylated compounds are 1.0 and between 1.1 and 1.4, respectively. ] [Note—The peak area of iohexol related compound C is 0.5% ± 0.1% compared to the total area of all the peaks in the chromatogram. ] Suitability requirements Resolution: NLT 20.0 between iohexol related compound A and iohexol related compound C Analysis Sample: Sample solution Excluding peaks with retention times between 0.84 (relative to the endo-isomer of iohexol, which is the first main peak) and 1.0, calculate the percentage of O-alkylated compounds and any other individual impurity peak, in the portion of Iohexol taken: Result = (rU/rT) × 100 rU = = peak response of each impurity rT = = sum of all the peak responses Acceptance criteria Individual impurity: NMT 0.6% of O-alkylated compounds; NMT 0.1% of any other individual impurity Total impurities: NMT 0.3%, excluding O-alkylated compounds SPECIFIC TESTS • Bacterial Endotoxins Test 85: NMT 0.2 USP Endotoxin Unit per 50 mg of iodine • pH 791: 6.8–7.7 • Particulate Matter in Injections 788: The Injection labeled for intrathecal use meets the requirements for small-volume injections. • Free Iodide: Transfer 5.0 mL of Injection to a suitable container, add 20 mL of water, and titrate with 0.001 N silver nitrate VS using a silver electrode in combination with an appropriate reference electrode. Each mL of 0.001 N silver nitrate is equivalent to 0.1269 mg of iodine. Acceptance criteria: NMT 0.02%, based on the content of iohexol • Injections 1: Meets the requirements ADDITIONAL REQUIREMENTS • Packaging and Storage: Preserve Injection intended for intravascular or intrathecal use in single-dose or multiple-dose plastic or Type I glass containers. Store at controlled room temperature, protected from light. Do not freeze. • Labeling: Label containers of Injection to direct the user to discard any unused portion. The labeling states also that it is not to be used if it is discolored or contains a precipitate. Label it also to state its routes of administration. When the specific dose strength is not intended for intrathecal use, label it to indicate “serious injury can occur if given by intrathecal route”. • USP Reference Standards 11 USP Endotoxin RS USP Iohexol RS USP Iohexol Related Compound A RS 5-(Acetylamino)-N,N¢-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-1,3-benzenedicarboxamide. USP Iohexol Related Compound C RS N,N¢-Bis(2,3-dihydroxypropyl)-5-nitro-1,3-benzenedicarboxamide. |
3樓2015-05-18 16:43:55
5樓2015-05-19 09:15:37
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考研] 材料學碩301分求調劑 +7 | Liyouyumairs 2026-03-21 | 7/350 |
|
|---|---|---|---|---|
|
|
[考研] 326求調劑 +5 | 諾貝爾化學獎覬?/a> 2026-03-15 | 8/400 |
|
|
[考研] 297求調劑 +3 | 喜歡還是不甘心 2026-03-20 | 3/150 |
|
|
|
[考研] 311求調劑 +3 | 勇敢的小吳 2026-03-20 | 3/150 |
|
|
|
[考研] 生物學一志愿985，分數(shù)349求調劑 +3 | zxts12 2026-03-21 | 3/150 |
|
|
|
[考研] 070300化學319求調劑 +7 | 錦鯉0909 2026-03-17 | 7/350 |
|
|
|
[考研] 08工科 320總分 求調劑 +6 | 梨花珞晚風 2026-03-17 | 6/300 |
|
|
|
[考研] 265求調劑 +3 | Jack?k?y 2026-03-17 | 3/150 |
|
|
|
[考研] 265求調劑 +9 | 梁梁校校 2026-03-17 | 9/450 |
|
|
|
[考研] 南京大學化學376求調劑 +3 | hisfailed 2026-03-19 | 6/300 |
|
|
|
[考研] 308求調劑 +3 | 阿姐阿姐家啊 2026-03-18 | 3/150 |
|
|
|
[考研] 321求調劑 +9 | 何潤采123 2026-03-18 | 11/550 |
|
|
|
[考研] 323求調劑 +3 | 洼小桶 2026-03-18 | 3/150 |
|
|
|
[考研] 350求調劑 +5 | weudhdk 2026-03-19 | 5/250 |
|
|
|
[考研] 085410人工智能專碩317求調劑（0854都可以） +4 | xbxudjdn 2026-03-18 | 4/200 |
|
|
|
[考博] 申博26年 +3 | 八6八68 2026-03-19 | 3/150 |
|
|
|
[考研] 本科鄭州大學物理學院，一志愿華科070200學碩，346求調劑 +4 | 我不是一根蔥 2026-03-18 | 4/200 |
|
|
|
[考研] 收復試調劑生 +4 | 雨后秋荷 2026-03-18 | 4/200 |
|
|
|
[考研] 085601求調劑 +4 | Du.11 2026-03-16 | 4/200 |
|
|
|
[考研] 考研調劑 +3 | 淇ya_~ 2026-03-17 | 5/250 |
|