多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.396652366429665606639066283664370.17
210.506818468423683040.25
单位质量响应值RSD%判断
6394.326505.141.22数据可信
供试品溶液-2025072321批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17033-70339.78413.5317.869.7813.5317.87
210013-1001313.93013.93
312385-1238517.23017.23
49056-905612.59912.60
510210-1021014.20414.20
69677-967713.46213.46
10min114407-1440720.04323.568.3720.0623.588.37
217553-1755324.41924.44
318636-1863625.92625.95
416653-1665323.16723.19
517479-1747924.31624.34
616894-1689423.50323.53
15min119664-1966427.35631.108.5327.4131.168.51
221888-2188830.45030.51
322958-2295831.93932.01
425457-2545735.41535.47
522628-2262831.48031.54
621553-2155329.98430.05
20min123645-2364532.89535.153.9432.9935.273.95
225181-2518135.03135.15
326637-2663737.05737.18
425223-2522335.09035.21
525876-2587635.99836.11
625056-2505634.85734.97
30min128717-2871739.95141.802.3940.1041.972.41
229921-2992141.62641.80
330838-3083842.90143.09
430290-3029042.13942.32
530296-3029642.14742.32
630218-3021842.03942.21
45min133636-3363646.79448.042.0647.0148.282.07
234249-3424947.64747.89
335076-3507648.79749.06
435262-3526249.05649.30
535115-3511548.85149.10
633851-3385147.09347.33
60min137290-3729051.87753.202.6452.1753.522.65
237604-3760452.31452.64
340053-4005355.72156.06
438269-3826953.23953.57
538581-3858153.67354.00
637630-3763052.35052.67
90min141329-4132957.49658.621.3557.8859.031.36
241792-4179258.14058.55
342156-4215658.64759.08
442604-4260459.27059.69
542914-4291459.70160.12
642033-4203358.47658.88
120min145439-4543963.21462.451.5663.6962.961.55
243899-4389961.07261.58
344706-4470662.19462.72
445640-4564063.49464.01
545356-4535663.09963.62
644298-4429861.62762.13
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限145343-4534363.08064.091.8163.6664.701.82
245108-4510862.75463.36
346998-4699865.38366.02
446904-4690465.25265.87
546508-4650864.70165.32
645564-4556463.38863.99
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.396794567966682676746167884679050.43
210.506991669709698120.21
单位质量响应值RSD%判断
6535.616648.761.22数据可信
供试品溶液-2025072321批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min19109-910912.39811.3113.7312.4011.3113.74
28418-841811.45811.46
36735-67359.1679.17
49967-996713.56613.57
58050-805010.95710.96
67563-756310.29410.29
10min117051-1705123.20821.578.1923.2321.598.19
215610-1561021.24721.27
314163-1416319.27819.29
417542-1754223.87723.90
515970-1597021.73721.76
614762-1476220.09320.11
15min121575-2157529.36628.124.7329.4328.184.74
220543-2054327.96228.02
319435-1943526.45326.50
421914-2191429.82829.89
520757-2075728.25328.31
619750-1975026.88226.93
20min125052-2505234.09933.073.1834.2133.173.19
224121-2412132.83232.93
323063-2306331.39231.48
425116-2511634.18634.30
524492-2449233.33733.44
623930-2393032.57232.67
30min129412-2941240.03339.702.2740.2039.862.28
228972-2897239.43439.59
328575-2857538.89439.04
430186-3018641.08741.26
529473-2947340.11640.27
628393-2839338.64638.80
45min134382-3438246.79846.481.8247.0346.701.83
233351-3335145.39545.62
333586-3358645.71545.92
435095-3509547.76948.01
534257-3425746.62846.85
634196-3419646.54546.76
60min137355-3735550.84550.961.5251.1551.261.53
236613-3661349.83550.13
337123-3712350.52950.81
437838-3783851.50251.82
538253-3825352.06752.37
637452-3745250.97751.27
90min141414-4141456.36956.641.1256.7657.021.12
240938-4093855.72256.10
341817-4181756.91857.29
441946-4194657.09457.50
542210-4221057.45357.84
641344-4134456.27456.65
120min144439-4443960.48760.670.8460.9861.150.85
244402-4440260.43660.91
344188-4418860.14560.61
445180-4518061.49561.99
544864-4486461.06561.55
644369-4436960.39260.86
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限145474-4547461.89662.130.9962.4862.710.99
244880-4488061.08761.66
345979-4597962.58363.15
446160-4616062.82963.43
545757-4575762.28162.87
645638-4563862.11962.69
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