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%
111.049542595393949989560795672954190.28
211.049579895743957700.05
单位质量响应值RSD%判断
8643.038674.820.26数据可信
供试品溶液-2025051521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%
5min126835-2683527.82831.8017.4127.8331.8017.41
221492-2149222.28722.29
333854-3385435.10735.11
434873-3487336.16336.16
533668-3366834.91434.91
633260-3326034.49134.49
10min146120-4612047.82750.705.2548.1451.055.33
245152-4515246.82347.07
350542-5054252.41252.80
451102-5110252.99353.39
550510-5051052.37952.77
649913-4991351.76052.14
15min153674-5367455.66058.383.6456.5059.293.69
254736-5473656.76157.53
356887-5688758.99259.96
457030-5703059.14060.13
555882-5588257.95058.92
659544-5954461.74762.71
20min159418-5941861.61762.521.6963.0864.091.81
258776-5877660.95162.35
361378-6137863.64965.28
460576-6057662.81864.47
560385-6038562.61964.23
661208-6120863.47365.12
30min164343-6434366.72468.351.5468.8770.611.63
265131-6513167.54169.62
367135-6713569.61971.95
466433-6643368.89171.24
566416-6641668.87471.18
665984-6598468.42670.78
45min169330-6933071.89571.701.1974.7874.721.23
267997-6799770.51373.34
369167-6916771.72674.84
468402-6840270.93374.04
570130-7013072.72575.80
669830-6983072.41475.52
60min170078-7007872.67174.121.2876.3677.941.29
271649-7164974.30077.91
370733-7073373.35077.26
472476-7247675.15879.06
571742-7174274.39778.28
672192-7219274.86378.78
90min174424-7442477.17877.250.4181.6781.880.51
274136-7413676.87981.31
374176-7417676.92181.64
474877-7487777.64882.38
574765-7476577.53282.24
674568-7456877.32782.07
120min171102-7110273.73374.401.0479.0879.890.97
272344-7234475.02180.31
370920-7092073.54479.12
472104-7210474.77280.37
572707-7270775.39780.97
671267-7126773.90479.51
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172957-7295775.65775.590.7281.8281.910.73
272503-7250375.18681.31
372761-7276175.45381.85
473465-7346576.18382.61
573484-7348476.20382.61
672182-7218274.85381.28
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%
111.049551495686954999562595367955380.13
211.049603195936959840.07
单位质量响应值RSD%判断
8653.808694.200.33数据可信
供试品溶液-2025051621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%
5min132809-3280933.96429.6718.7533.9629.6718.75
227622-2762228.59428.59
328743-2874329.75529.75
418624-1862419.28019.28
533039-3303934.20234.20
631134-3113432.23032.23
10min149966-4996651.72550.046.6052.1050.376.68
247811-4781149.49449.81
348074-4807449.76650.10
442433-4243343.92744.14
551042-5104252.83953.22
650715-5071552.50052.86
15min157611-5761159.63958.183.0260.5959.073.12
256491-5649158.48059.35
354483-5448356.40157.28
453774-5377455.66756.37
557876-5787659.91360.88
656987-5698758.99359.93
20min161494-6149463.65962.861.8265.2764.391.94
259942-5994262.05263.57
360586-6058662.71964.23
459026-5902661.10462.42
561287-6128763.44465.08
662001-6200164.18465.78
30min166729-6672969.07868.720.8671.4070.960.95
266903-6690369.25871.47
365619-6561967.92970.14
465771-6577168.08670.09
566403-6640368.74171.08
666888-6688869.24371.55
45min169610-6961072.06072.510.6675.1575.500.71
270061-7006172.52775.50
369791-6979172.24875.21
469815-6981572.27375.03
570057-7005772.52375.62
670913-7091373.40976.49
60min171865-7186574.39574.641.1578.2978.441.04
272630-7263075.18778.97
370893-7089373.38977.15
473006-7300675.57679.14
571470-7147073.98677.89
672728-7272875.28879.18
90min175517-7551778.17577.940.7682.8982.570.61
274742-7474277.37381.99
375225-7522577.87382.45
476299-7629978.98583.38
574824-7482477.45882.19
675139-7513977.78482.52
120min176345-7634579.03379.071.1284.6284.560.99
275404-7540478.05883.54
375625-7562578.28783.73
477778-7777880.51685.79
576732-7673279.43385.02
676392-7639279.08184.68
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178697-7869781.46780.621.2487.9387.001.13
278096-7809680.84587.19
376359-7635979.04785.36
479017-7901781.79987.97
577337-7733780.05986.53
677787-7778780.52587.00
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%
111.049678396611970469666196640967480.19
211.049672996685967070.04
单位质量响应值RSD%判断
8763.418759.690.04数据可信
供试品溶液-2025051622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%
5min127096-2709627.76930.0311.9327.7730.0311.93
231156-3115631.93031.93
333364-3336434.19334.19
431565-3156532.34932.35
523742-2374224.33224.33
628889-2888929.60729.61
10min147437-4743748.61649.725.1148.9250.065.15
249515-4951550.74651.10
351273-5127352.54752.93
449708-4970850.94351.30
544138-4413845.23545.51
649038-4903850.25750.59
15min154683-5468356.04257.372.9856.8958.263.03
257298-5729858.72259.64
358719-5871960.17861.14
455550-5555056.93157.86
554573-5457355.92956.70
655075-5507556.44457.33
20min158782-5878260.24361.652.0861.7163.182.15
261199-6119962.72064.29
361393-6139362.91964.55
461003-6100362.51964.08
558570-5857060.02661.42
660011-6001161.50263.02
30min166004-6600467.64467.321.2869.7969.531.36
266055-6605567.69769.96
366388-6638868.03870.37
466324-6632467.97270.23
564257-6425765.85467.92
665101-6510166.71968.92
45min168999-6899970.71471.511.4173.6174.471.48
269348-6934871.07274.09
371297-7129773.06976.16
470167-7016771.91174.92
568611-6861170.31673.11
670239-7023971.98574.92
60min172488-7248874.29074.050.4377.9777.800.44
271906-7190673.69377.50
372708-7270874.51578.41
472045-7204573.83677.64
572319-7231974.11677.69
672057-7205773.84877.59
90min176148-7614878.04177.330.8582.5481.900.77
275505-7550577.38282.01
374458-7445876.30981.04
476099-7609977.99082.62
575098-7509876.96481.36
675418-7541877.29281.85
120min175648-7564877.52876.712.3282.9082.142.28
275281-7528177.15282.64
375917-7591777.80483.38
476666-7666678.57184.07
572006-7200673.79679.05
673553-7355375.38180.80
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172418-7241874.21875.481.6080.4581.761.53
273961-7396175.79982.14
372729-7272974.53780.98
475711-7571177.59383.96
573221-7322175.04181.11
673840-7384075.67581.93
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