他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382567332562982558662565222558982562630.15
212.442555332557282556300.06
单位质量响应值RSD%判断
20699.7620549.040.52数据可信
供试品溶液-2025091622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%
5min128423-2842311.01710.7417.5211.0210.7417.51
228371-2837110.99711.00
318385-183857.1267.13
429704-2970411.51411.51
532710-3271012.67912.68
628671-2867111.11411.11
10min150899-5089919.73019.147.9419.7319.147.94
250282-5028219.49019.49
342958-4295816.65216.65
454786-5478621.23621.24
549627-4962719.23719.24
647638-4763818.46618.47
15min160636-6063623.50422.815.3123.5022.815.30
259655-5965523.12423.12
354579-5457921.15621.16
463391-6339124.57224.57
558380-5838022.62922.63
656453-5645321.88321.88
20min166074-6607425.61225.123.7425.6125.123.74
265334-6533425.32525.33
362027-6202724.04324.04
468726-6872626.64026.64
563608-6360824.65624.66
663090-6309024.45524.46
30min173152-7315228.35528.032.6928.3628.032.70
273084-7308428.32928.33
370569-7056927.35427.35
475398-7539829.22629.23
571293-7129327.63527.63
670322-7032227.25827.26
45min178445-7844530.40730.101.7630.4130.101.76
277575-7757530.07030.07
377001-7700129.84729.85
479949-7994930.99030.99
576540-7654029.66929.67
676342-7634229.59229.59
极限182522-8252231.98731.920.9131.9931.920.90
282203-8220331.86431.86
382140-8214031.83931.84
483753-8375332.46532.46
581755-8175531.69031.69
681742-8174231.68531.69
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382557592558552559332565652554932559210.16
212.442600632604372602500.11
单位质量响应值RSD%判断
20672.1320920.420.85数据可信
供试品溶液-2025091721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%
5min133327-3332712.81212.458.1612.8112.458.16
232748-3274812.58912.59
334480-3448013.25513.26
435005-3500513.45713.46
530874-3087411.86911.87
627880-2788010.71810.72
10min151854-5185419.93420.214.6319.9320.214.63
251132-5113219.65719.66
355847-5584721.46921.47
454826-5482621.07721.08
552536-5253620.19620.20
649233-4923318.92718.93
15min159825-5982522.99823.213.2223.0023.213.22
259068-5906822.70722.71
363550-6355024.43024.43
461084-6108423.48223.48
560822-6082223.38223.38
657905-5790522.26022.26
20min164229-6422924.69125.233.3624.6925.233.37
264286-6428624.71324.71
369448-6944826.69826.70
466207-6620725.45225.45
566245-6624525.46625.47
663349-6334924.35324.35
30min170706-7070627.18127.802.3627.1827.802.35
270909-7090927.25927.26
374875-7487528.78428.78
472838-7283828.00128.00
573516-7351628.26228.26
671044-7104427.31127.31
45min175919-7591929.18529.792.0229.1929.782.02
276538-7653829.42329.42
380093-8009330.79030.79
477834-7783429.92229.92
578200-7820030.06230.06
676306-7630629.33429.33
极限181009-8100931.14231.601.3231.1431.601.32
281320-8132031.26231.26
383707-8370732.17932.18
482824-8282431.84031.84
582887-8288731.86431.86
681509-8150931.33431.33
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382581482575472575462578662577332577680.10
212.442583112581092582100.06
单位质量响应值RSD%判断
20821.3220756.430.23数据可信
供试品溶液-2025091722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%
5min132824-3282412.6239.7232.1612.629.7232.15
232288-3228812.41612.42
331057-3105711.94311.94
417074-170746.5666.57
514225-142255.4705.47
624169-241699.2949.29
10min152005-5200519.99917.3114.8820.0017.3114.89
250935-5093519.58719.59
349688-4968819.10819.11
438092-3809214.64814.65
537041-3704114.24414.24
642367-4236716.29216.29
15min160169-6016923.13820.899.9823.1420.899.99
259703-5970322.95922.96
357561-5756122.13522.14
448796-4879618.76518.76
548704-4870418.72918.73
650987-5098719.60719.61
20min165861-6586125.32723.227.8925.3323.227.89
265202-6520225.07425.07
362716-6271624.11824.12
455596-5559621.38021.38
555728-5572821.43021.43
657199-5719921.99622.00
30min171305-7130527.42125.835.8727.4225.835.87
271189-7118927.37627.38
369664-6966426.78926.79
463865-6386524.55924.56
563270-6327024.33124.33
663708-6370824.49924.50
45min177324-7732429.73528.454.0029.7428.444.01
276942-7694229.58829.59
375548-7554829.05229.05
471598-7159827.53327.53
571569-7156927.52227.52
670840-7084027.24227.24
极限181162-8116231.21130.791.8031.2130.791.80
281690-8169031.41431.41
380841-8084131.08831.09
479304-7930430.49730.50
579669-7966930.63730.64
677790-7779029.91429.91
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.385191725187145181865178845197155187340.15
212.445223565217805220680.08
单位质量响应值RSD%判断
41900.9741966.880.12数据可信
供试品溶液-2025091821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%
5min136382-363826.9366.842.516.946.842.56
236645-366456.9866.99
335578-355786.7836.78
434897-348976.6536.65
534823-348236.6396.64
636904-369047.0357.04
10min159703-5970311.38211.092.5411.3811.092.55
259878-5987811.41511.42
358757-5875711.20211.20
457117-5711710.88910.89
557401-5740110.94310.94
656281-5628110.73010.73
15min169390-6939013.22913.101.7313.2313.101.72
269158-6915813.18413.18
370497-7049713.44013.44
467699-6769912.90612.91
568362-6836213.03313.03
667295-6729512.82912.83
20min175504-7550414.39414.251.2714.3914.251.28
274778-7477814.25614.26
375594-7559414.41114.41
475002-7500214.29914.30
574593-7459314.22114.22
672978-7297813.91313.91
30min179948-7994815.24215.291.4715.2415.291.47
280020-8002015.25515.26
381355-8135515.51015.51
481568-8156815.55015.55
579922-7992215.23715.24
678328-7832814.93314.93
45min183786-8378615.97315.961.1815.9715.961.17
283229-8322915.86715.87
384423-8442316.09516.09
484909-8490916.18716.19
583764-8376415.96915.97
682073-8207315.64715.65
极限185922-8592216.38016.591.0916.3816.591.11
286936-8693616.57416.57
387846-8784616.74716.75
488066-8806616.78916.79
587495-8749516.68016.68
685893-8589316.37516.37
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