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%
1 11.089927199801997569958899612996060.21
2 11.161000181002051001120.14
单位质量响应值RSD%判断
8989.718970.610.16数据可信
供试品溶液-2025032021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%
5min114795-1479514.79412.1422.0014.7912.1421.98
29980-99809.9799.98
313293-1329313.29213.29
411527-1152711.52611.53
58329-83298.3288.33
614913-1491314.91214.91
10min129349-2934929.34628.967.2329.5129.097.29
226859-2685926.85626.97
329437-2943729.43429.58
429683-2968329.68029.81
526353-2635326.35126.44
632083-3208332.08032.25
15min136544-3654436.54136.904.0037.0337.364.08
235664-3566435.66136.07
337005-3700537.00137.48
437667-3766737.66338.12
535233-3523335.23035.61
639320-3932039.31639.84
20min141804-4180441.80041.441.8142.7042.311.93
240807-4080740.80341.61
342005-4200542.00142.89
441377-4137741.37342.25
540361-4036140.35741.13
642329-4232942.32543.28
30min145696-4569645.69245.871.2547.0547.201.32
245676-4567645.67246.93
346512-4651246.50847.86
446432-4643246.42847.76
544963-4496344.95946.18
645967-4596745.96347.39
45min147529-4752947.52548.601.3249.3950.441.26
248949-4894948.94450.71
348516-4851648.51150.38
448282-4828248.27750.13
549051-4905149.04650.77
649290-4929049.28551.23
60min148626-4862648.62149.591.6651.0251.961.69
249290-4929049.28551.60
350262-5026250.25752.67
450291-5029150.28652.67
548696-4869648.69150.96
650376-5037650.37152.86
90min150208-5020850.20351.111.1853.1454.041.11
251887-5188751.88254.74
350949-5094950.94453.91
451644-5164451.63954.59
550850-5085050.84553.66
651162-5116251.15754.20
120min149904-4990449.89952.022.2753.3955.512.11
253417-5341753.41256.85
352207-5220752.20255.73
452695-5269552.69056.21
552040-5204052.03555.41
651879-5187951.87455.49
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149768-4976849.76351.531.8853.8155.601.77
251652-5165251.64755.67
352015-5201552.01056.12
451187-5118751.18255.29
552237-5223752.23256.19
652349-5234952.34456.54
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%
1 11.089983999817998409958599733997630.11
2 11.169979999655997270.11
单位质量响应值RSD%判断
9003.888936.110.54数据可信
供试品溶液-2025032021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%
5min18984-89848.99312.4240.998.9912.4241.01
28179-81798.1888.19
311418-1141811.43011.43
412849-1284912.86312.86
510803-1080310.81410.81
622202-2220222.22522.23
10min128313-2831328.34329.7013.4128.4429.8413.53
225135-2513525.16125.25
329031-2903129.06229.19
431318-3131831.35131.49
527561-2756127.59027.71
636675-3667536.71436.96
15min136482-3648236.52036.716.0136.9437.186.19
233563-3356333.59833.97
336520-3652036.55837.01
437445-3744537.48437.98
535741-3574135.77936.21
640282-4028240.32440.98
20min140264-4026440.30640.774.4541.1341.654.63
238448-3844838.48839.23
341297-4129741.34042.20
441353-4135341.39642.30
539392-3939239.43340.26
643636-4363643.68244.78
30min144640-4464044.68745.132.1045.9646.462.33
244488-4448844.53545.71
345353-4535345.40146.72
444960-4496045.00746.37
544232-4423244.27945.54
646840-4684046.88948.48
45min147376-4737647.42647.940.9349.1949.781.05
247964-4796448.01449.68
348415-4841548.46650.29
448228-4822848.27950.15
547339-4733947.38949.14
648042-4804248.09350.20
60min148025-4802548.07549.331.4050.3751.691.42
249822-4982249.87452.07
349738-4973849.79052.15
448997-4899749.04951.45
549364-4936449.41651.70
649721-4972149.77352.42
90min149936-4993649.98950.720.9552.8153.630.91
251153-5115351.20753.96
351120-5112051.17454.09
450291-5029150.34453.29
550862-5086250.91553.75
650634-5063450.68753.88
120min151202-5120251.25650.780.6354.6454.260.42
250754-5075450.80754.13
350782-5078250.83554.32
450779-5077950.83254.34
550650-5065050.70354.10
650209-5020950.26254.02
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150269-5026950.32250.890.9654.2754.930.98
250674-5067450.72754.61
351714-5171451.76855.81
450617-5061750.67054.74
550926-5092650.98054.94
650839-5083950.89255.21
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%
1 11.0899953100144100145998871001871000630.14
2 11.169928399433993580.11
单位质量响应值RSD%判断
9030.968903.051.01数据可信
供试品溶液-2025032021批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120806-2080620.83617.0130.8220.8417.0130.82
222810-2281022.84222.84
313421-1342113.44013.44
412926-1292612.94412.94
521312-2131221.34221.34
610623-1062310.63810.64
10min135331-3533135.38132.808.5735.6132.998.68
234604-3460434.65334.91
330334-3033430.37730.53
432300-3230032.34632.49
535284-3528435.33435.57
628650-2865028.69128.81
15min139814-3981439.87138.654.2240.5039.204.36
239929-3992939.98640.62
337229-3722937.28237.77
439284-3928439.34039.84
539350-3935039.40640.04
635945-3594535.99636.43
20min142632-4263242.69342.241.9043.7643.222.01
242511-4251142.57143.65
341885-4188541.94542.85
443075-4307543.13644.08
542214-4221442.27443.34
640773-4077340.83141.67
30min145570-4557045.63545.110.6347.1846.560.76
244925-4492544.98946.55
345083-4508345.14746.51
445018-4501845.08246.50
544957-4495745.02146.56
644731-4473144.79546.09
45min147744-4774447.81247.850.6849.8649.800.61
247569-4756947.63749.69
347475-4747547.54349.41
448335-4833548.40450.32
547571-4757147.63949.68
647968-4796848.03649.82
60min147014-4701447.08146.890.8049.6649.380.70
246258-4625846.32448.91
347355-4735547.42249.82
446598-4659846.66449.12
546883-4688346.95049.52
646858-4685846.92549.25
90min147015-4701547.08247.951.5350.1950.951.28
247382-4738247.44950.55
349046-4904649.11652.04
447670-4767047.73850.71
547775-4777547.84350.93
648379-4837948.44851.29
120min146134-4613446.20046.961.0349.8350.500.94
247531-4753147.59951.23
347266-4726647.33350.80
446783-4678346.85050.36
546724-4672446.79050.41
646912-4691246.97950.36
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146593-4659346.65946.801.3350.8050.861.26
247117-4711747.18451.34
347657-4765747.72551.72
446859-4685946.92650.95
546153-4615346.21950.36
645993-4599346.05849.96
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