玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959761597466974829755597448975130.08
211.009736197319973400.04
单位质量响应值RSD%判断
8905.308849.090.45数据可信
供试品溶液-2025051221批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113566-1356613.72214.4623.2413.7214.4623.25
215913-1591316.09616.10
310755-1075510.87910.88
410375-1037510.49410.49
518686-1868618.90118.90
616506-1650616.69616.70
10min129178-2917829.51429.556.8729.6729.726.95
229506-2950629.84630.02
327204-2720427.51727.64
426687-2668726.99427.11
530954-3095431.31031.52
631778-3177832.14432.33
15min136025-3602536.44037.264.7936.9237.744.87
236953-3695337.37837.89
335460-3546035.86836.29
434759-3475935.15935.58
538627-3862739.07239.63
639171-3917139.62240.16
20min140060-4006040.52140.922.4541.4141.822.59
240793-4079341.26342.19
339632-3963240.08840.91
439191-3919139.64240.45
541348-4134841.82442.82
641704-4170442.18443.17
30min145084-4508445.60345.800.6546.9447.160.81
245374-4537445.89647.28
345123-4512345.64246.91
444912-4491245.42946.68
545437-4543745.96047.42
645719-4571946.24547.70
45min147159-4715947.70248.490.8549.5450.360.83
248147-4814748.70150.60
348015-4801548.56850.35
448306-4830648.86250.61
548120-4812048.67450.64
647870-4787048.42150.39
60min148907-4890749.47049.910.5451.8452.320.57
249315-4931549.88352.32
349551-4955150.12152.44
449366-4936649.93452.23
549257-4925749.82452.33
649676-4967650.24852.75
90min150251-5025150.83051.191.2053.7554.151.14
249844-4984450.41853.41
350277-5027750.85653.73
451488-5148852.08154.93
551091-5109151.67954.74
650695-5069551.27954.34
120min149178-4917849.74451.651.8553.2355.181.75
251550-5155052.14355.69
351734-5173452.33055.77
451449-5144952.04155.47
551291-5129151.88155.52
651156-5115651.74555.38
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149602-4960250.17351.341.1854.2155.441.15
250612-5061251.19555.32
351126-5112651.71555.74
451098-5109851.68655.69
551063-5106351.65155.86
651023-5102351.61055.82
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959810898161981709820298066981410.06
211.009784097791978160.04
单位质量响应值RSD%判断
8962.658892.360.56数据可信
供试品溶液-2025051321批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115447-1544715.53716.3028.8315.5416.3028.82
211332-1133211.39811.40
313322-1332213.39913.40
413147-1314713.22313.22
522183-2218322.31222.31
621807-2180721.93421.93
10min131359-3135931.54130.808.6531.7130.988.77
227864-2786428.02628.15
328844-2884429.01229.16
428412-2841228.57728.72
534234-3423434.43334.68
633030-3303033.22233.47
15min137709-3770937.92837.664.5738.4538.194.72
235560-3556035.76736.20
336623-3662336.83637.31
435914-3591436.12336.59
539585-3958539.81540.45
639281-3928139.51040.12
20min141546-4154641.78841.612.5542.7342.552.71
240835-4083541.07341.91
340749-4074940.98641.87
439962-3996240.19441.06
542696-4269642.94444.02
642414-4241442.66143.71
30min145954-4595446.22146.041.4447.6347.441.62
245378-4537845.64246.93
345074-4507445.33646.67
445194-4519445.45746.77
546681-4668146.95348.50
646331-4633146.60148.13
45min146909-4690947.18248.231.3949.1050.141.36
248086-4808648.36650.16
348233-4823348.51450.35
448208-4820848.48850.31
548798-4879849.08251.15
647463-4746347.73949.78
60min149139-4913949.42549.840.6551.8752.290.68
249223-4922349.50951.85
349990-4999050.28152.66
449699-4969949.98852.34
549620-4962049.90952.53
649644-4964449.93352.51
90min149905-4990550.19550.880.7653.1953.880.76
250469-5046950.76353.65
350954-5095451.25054.19
450746-5074651.04153.95
550530-5053050.82454.00
650890-5089051.18654.31
120min150830-5083051.12651.670.8154.6855.240.77
251138-5113851.43554.89
351381-5138151.68055.19
452080-5208052.38355.86
551416-5141651.71555.45
651375-5137551.67455.37
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151586-5158651.88651.531.1156.0155.681.09
250800-5080051.09655.12
351630-5163051.93056.01
450702-5070250.99755.06
550700-5070050.99555.31
651979-5197952.28156.55
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109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(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.959792797976980139773897772978850.13
211.009741897690975540.20
单位质量响应值RSD%判断
8939.278868.550.57数据可信
供试品溶液-2025051421批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121241-2124121.42118.9119.1321.4218.9119.13
224624-2462424.83324.83
316617-1661716.75816.76
415102-1510215.23015.23
518544-1854418.70118.70
616365-1636516.50416.50
10min134026-3402634.31532.136.2234.5532.346.29
234396-3439634.68834.96
331605-3160531.87332.06
429729-2972929.98130.15
531507-3150731.77431.98
629923-2992330.17730.36
15min138241-3824138.56537.722.6139.1838.292.71
238733-3873339.06239.72
337650-3765037.96938.51
436275-3627536.58337.09
537047-3704737.36137.92
636497-3649736.80737.33
20min141051-4105141.39941.261.6542.4542.251.76
241990-4199042.34643.44
341275-4127541.62542.59
440115-4011540.45541.36
540397-4039740.74041.72
640662-4066241.00741.93
30min144230-4423044.60544.871.2446.1146.321.30
245468-4546845.85447.42
344290-4429044.66646.09
444834-4483445.21446.57
544057-4405744.43145.86
644105-4410544.47945.86
45min146257-4625746.64947.901.4148.6549.841.38
248257-4825748.66650.74
347737-4773748.14250.06
447484-4748447.88749.75
547728-4772848.13350.06
647502-4750247.90549.78
60min147619-4761948.02349.091.5250.5451.571.47
249443-4944349.86252.48
348131-4813148.53951.00
448495-4849548.90651.30
548929-4892949.34451.80
649473-4947349.89352.30
90min148714-4871449.12750.441.4852.1853.461.36
250018-5001850.44253.61
350309-5030950.73653.73
449859-4985950.28253.22
550268-5026850.69453.70
650949-5094951.38154.35
120min151452-5145251.88851.321.3555.4954.901.25
250427-5042750.85554.59
349914-4991450.33753.90
450842-5084251.27354.77
551820-5182052.26055.83
650887-5088751.31954.85
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150337-5033750.76451.150.7354.9455.300.74
251166-5116651.60055.90
351105-5110551.53955.66
450709-5070951.13955.20
550297-5029750.72454.87
650702-5070251.13255.24
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