托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.549862298517987089861598771986470.10
216.579939699332993640.05
单位质量响应值RSD%判断
5964.155996.620.39数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111005-1100511.04110.972.3911.0410.972.39
210689-1068910.72410.72
310583-1058310.61810.62
411230-1123011.26711.27
511188-1118811.22511.22
610909-1090910.94510.94
10min121457-2145721.52821.902.8821.5921.962.87
222048-2204822.12022.18
320791-2079120.85920.92
422229-2222922.30222.36
521878-2187821.95022.01
622563-2256322.63722.70
15min130951-3095131.05330.632.0131.2330.812.01
231025-3102531.12731.31
329342-2934229.43829.61
430729-3072930.83031.02
530570-3057030.67030.85
630540-3054030.64030.83
20min137230-3723037.35237.621.7437.7137.971.74
237892-3789238.01738.37
336311-3631136.43036.77
437624-3762437.74838.11
537774-3777437.89838.25
638125-3812538.25038.61
30min146709-4670946.86346.961.8447.4247.521.84
246995-4699547.14947.72
345185-4518545.33445.87
446947-4694747.10147.67
547550-4755047.70648.27
647475-4747547.63148.20
45min158372-5837258.56458.361.3959.3959.181.38
259403-5940359.59860.43
357450-5745057.63958.43
458166-5816658.35759.19
557139-5713957.32758.16
658472-5847258.66459.50
60min163736-6373663.94664.622.0265.0965.762.00
265096-6509665.31066.47
362081-6208162.28563.40
465318-6531865.53366.69
565470-6547065.68566.83
664730-6473064.94366.10
90min175623-7562375.87274.231.6777.3775.741.65
274998-7499875.24576.77
372486-7248672.72474.18
474395-7439574.64076.16
573555-7355573.79775.31
672864-7286473.10474.62
120min176901-7690177.15478.051.5679.0879.971.54
277861-7786178.11780.06
376392-7639276.64378.51
479922-7992280.18582.12
577920-7792078.17680.10
677772-7777278.02879.95
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181631-8163181.89981.221.0984.2583.571.08
281786-8178682.05584.43
380208-8020880.47282.76
481809-8180982.07884.46
580313-8031380.57782.93
679967-7996780.23082.59
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.549857998465983859859798553985160.10
216.579848098647985640.12
单位质量响应值RSD%判断
5956.235948.340.10数据可信
供试品溶液-1批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17601-76017.6627.434.497.667.434.50
27786-77867.8487.85
37533-75337.5937.59
46886-68866.9416.94
57305-73057.3647.36
67132-71327.1897.19
10min114752-1475214.87015.262.4514.9115.302.45
215476-1547615.60015.64
315469-1546915.59315.64
415475-1547515.59915.64
514761-1476114.87914.92
614897-1489715.01615.06
15min121739-2173921.91322.141.0322.0422.271.03
221870-2187022.04522.18
322285-2228522.46422.59
422210-2221022.38822.51
521881-2188122.05622.18
621805-2180521.98022.10
20min127530-2753027.75128.191.8028.0028.441.80
228588-2858828.81729.07
328518-2851828.74729.00
428032-2803228.25728.51
527744-2774427.96628.21
627399-2739927.61927.86
30min135494-3549435.77936.761.4236.1837.161.41
236901-3690137.19737.61
336489-3648936.78237.19
436406-3640636.69837.10
536612-3661236.90637.31
636881-3688137.17737.58
45min145973-4597346.34247.010.9946.9447.621.00
247099-4709947.47748.10
346863-4686347.23947.86
447068-4706847.44548.06
546245-4624546.61647.22
646539-4653946.91247.52
60min153154-5315453.58054.381.0354.4455.251.03
254393-5439354.82955.71
354031-5403154.46455.34
454409-5440954.84555.72
554330-5433054.76655.63
653360-5336053.78854.65
90min164910-6491065.43065.660.7766.5966.840.76
265654-6565466.18067.37
365353-6535365.87767.06
464314-6431464.83066.01
565576-6557666.10267.27
665027-6502765.54866.71
120min168928-6892869.48171.171.2371.0072.711.21
270548-7054871.11472.67
371175-7117571.74673.29
471265-7126571.83673.38
570826-7082671.39472.93
670906-7090671.47473.00
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174078-7407874.67274.851.2876.5876.781.24
273639-7363974.22976.18
373324-7332473.91275.86
475988-7598876.59778.54
574535-7453575.13377.07
673959-7395974.55276.48
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.549871099008988459885798921988680.12
216.579896998956989620.01
单位质量响应值RSD%判断
5977.515972.360.07数据可信
供试品溶液-2批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17531-75317.5637.739.027.567.739.02
27513-75137.5457.54
37261-72617.2917.29
47417-74177.4487.45
57376-73767.4077.41
69103-91039.1419.14
10min114394-1439414.45414.480.8414.5014.520.82
214581-1458114.64214.68
314432-1443214.49314.53
414340-1434014.40014.44
514510-1451014.57114.61
614244-1424414.30414.35
15min121100-2110021.18920.901.4221.3121.021.40
220878-2087820.96621.09
321045-2104521.13321.25
420383-2038320.46920.59
520958-2095821.04621.17
620522-2052220.60820.74
20min126829-2682926.94227.050.8327.1827.290.83
226686-2668626.79827.04
326795-2679526.90727.15
426912-2691227.02527.26
527140-2714027.25427.49
627274-2727427.38827.63
30min135720-3572035.87035.396.2536.2635.786.18
230835-3083530.96431.35
335968-3596836.11936.51
436908-3690837.06337.45
535838-3583835.98836.38
636179-3617936.33136.73
45min145857-4585746.04946.081.2246.6446.671.18
246503-4650346.69847.26
346258-4625846.45247.04
445874-4587446.06646.66
545974-4597446.16746.76
644875-4487545.06345.66
60min153677-5367753.90253.631.0054.7554.470.98
253457-5345753.68154.50
353555-5355553.78054.63
454011-5401154.23855.08
553300-5330053.52454.37
652442-5244252.66253.51
90min162336-6233662.59863.130.7663.7464.260.76
262394-6239462.65663.77
363211-6321163.47664.62
462661-6266162.92464.07
563523-6352363.78964.93
663055-6305563.32064.46
120min169917-6991770.21070.391.4171.7071.881.39
269275-6927569.56671.03
370932-7093271.23072.73
470302-7030270.59772.09
571383-7138371.68273.18
668780-6878069.06970.56
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173177-7317773.48473.681.6675.3775.571.63
273484-7348473.79275.65
373440-7344073.74875.64
473159-7315973.46675.36
575396-7539675.71277.61
671591-7159171.89173.77
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.549963199721995959933999208994990.22
216.579909798738989180.26
单位质量响应值RSD%判断
6015.665969.700.55数据可信
供试品溶液-24101601批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116807-1680716.82818.7312.8316.8318.7312.83
215512-1551215.53115.53
317924-1792417.94617.95
420178-2017820.20320.20
519765-1976519.78919.79
622034-2203422.06122.06
10min129102-2910229.13830.956.8329.2331.066.84
228162-2816228.19728.28
330792-3079230.83030.93
432578-3257832.61832.73
533851-3385133.89334.00
630997-3099731.03531.16
15min138172-3817238.21939.495.1538.4739.765.16
236964-3696437.01037.25
338444-3844438.49238.76
440198-4019840.24840.54
542722-4272242.77543.07
640128-4012840.17840.47
20min144786-4478644.84145.963.9645.3146.463.98
243138-4313843.19143.64
346007-4600746.06446.55
446986-4698647.04447.56
548425-4842548.48549.02
646082-4608246.13946.66
30min152472-5247252.53754.412.8453.2555.162.88
252277-5227752.34253.03
355217-5521755.28556.03
454990-5499055.05855.84
555395-5539555.46356.27
655694-5569455.76356.54
45min161028-6102861.10362.282.4062.1163.332.43
261007-6100761.08262.06
360527-6052760.60261.65
463719-6371963.79864.88
563549-6354963.62864.74
663367-6336763.44564.53
60min168363-6836368.44767.892.3469.8069.292.34
266686-6668666.76868.09
365722-6572265.80367.19
467074-6707467.15768.60
569986-6998670.07271.54
668981-6898169.06670.50
90min171426-7142671.51473.102.4173.2474.882.43
271700-7170071.78973.48
371235-7123571.32373.07
475139-7513975.23277.04
574660-7466074.75276.61
673929-7392974.02075.84
120min177756-7775677.85277.541.4679.9879.721.49
276307-7630776.40178.49
376187-7618776.28178.43
478491-7849178.58880.82
578888-7888878.98681.26
677018-7701877.11379.34
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178017-7801778.11378.831.6180.6781.441.65
276852-7685276.94779.46
378379-7837978.47681.05
479502-7950279.60082.27
580484-8048480.58383.29
679159-7915979.25781.92
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