多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.143308432933333813318133042331240.51
210.143292932653327910.60
单位质量响应值RSD%判断
3266.673233.830.72数据可信
供试品溶液-2025072522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%
5min17744-774421.37719.8813.6121.3819.8813.61
25524-552415.24915.25
38092-809222.33822.34
47696-769621.24521.24
57628-762821.05721.06
66517-651717.99017.99
10min113704-1370437.83036.069.5937.8736.109.60
210858-1085829.97430.00
314365-1436539.65539.69
413644-1364437.66437.70
513398-1339836.98537.02
612410-1241034.25834.29
15min117098-1709847.19946.685.6347.3046.775.65
215145-1514541.80841.88
317920-1792049.46849.57
417294-1729447.74047.84
517311-1731147.78747.88
616685-1668546.05946.15
20min120250-2025055.90053.903.8156.0854.073.82
218211-1821150.27250.42
319963-1996355.10855.29
419923-1992354.99855.18
519653-1965354.25254.43
619151-1915152.86653.03
30min122685-2268562.62262.532.0862.8962.792.10
221778-2177860.11860.35
323092-2309263.74664.02
423026-2302663.56363.83
522731-2273162.74963.02
622595-2259562.37462.63
45min126355-2635572.75371.081.7273.1371.441.73
225170-2517069.48269.81
326070-2607071.96672.35
425926-2592671.56971.94
525485-2548570.35270.72
625490-2549070.36570.72
60min127260-2726075.25175.381.3775.7575.871.38
226779-2677973.92474.37
327551-2755176.05576.56
427873-2787376.94477.44
527145-2714574.93475.42
627241-2724175.19975.67
90min128943-2894379.89780.511.1680.5281.121.16
228821-2882179.56180.13
329285-2928580.84181.47
429769-2976982.17882.80
529049-2904980.19080.80
629119-2911980.38380.98
120min130107-3010783.11183.521.3983.8784.261.40
229935-2993582.63683.34
330449-3044984.05584.82
431022-3102285.63686.40
529956-2995682.69483.44
630052-3005282.95983.69
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130378-3037883.85984.561.0384.7585.441.04
230322-3032283.70484.54
330844-3084485.14586.05
431136-3113685.95186.85
530443-3044384.03884.92
630668-3066884.65985.53
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.143255232919329083285433170328810.68
210.143307633261331680.40
单位质量响应值RSD%判断
3242.703271.010.62数据可信
供试品溶液-2025072522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%
5min18154-815422.46322.157.8122.4622.157.80
29042-904224.91024.91
37302-730220.11620.12
47527-752720.73620.74
58371-837123.06123.06
67852-785221.63121.63
10min115387-1538742.38939.015.1042.4339.055.10
214486-1448639.90739.95
313857-1385738.17438.21
413712-1371237.77537.81
513325-1332536.70936.75
614194-1419439.10339.14
15min117650-1765048.62448.302.3148.7348.402.31
218227-1822750.21350.32
317384-1738447.89147.99
417521-1752148.26848.37
517004-1700446.84446.94
617405-1740547.94948.05
20min119948-1994854.95555.052.0355.1455.232.04
220507-2050756.49456.69
319554-1955453.86954.05
420053-2005355.24455.42
519497-1949753.71253.89
620331-2033156.01056.19
30min122775-2277562.74363.192.4263.0263.462.42
223631-2363165.10165.39
322935-2293563.18363.45
423093-2309363.61963.89
521973-2197360.53360.80
623215-2321563.95564.23
45min126139-2613972.01070.792.4672.4071.182.46
226186-2618672.14072.53
325344-2534469.82070.19
426037-2603771.72972.11
524570-2457067.68868.06
625909-2590971.37671.76
60min127655-2765576.18675.371.6676.6975.871.67
227572-2757275.95876.47
327132-2713274.74675.23
427518-2751875.80976.30
526539-2653973.11273.59
627743-2774376.42976.93
90min129240-2924080.55380.631.7981.1981.251.79
229372-2937280.91781.56
329290-2929080.69181.30
429670-2967081.73882.36
528284-2828477.91978.52
629744-2974481.94182.57
120min130791-3079184.82683.852.0385.5984.612.03
230531-3053184.10984.89
330963-3096385.30086.05
430708-3070884.59785.36
529246-2924680.56981.30
630378-3037883.68884.45
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131218-3121886.00284.741.2586.9185.641.26
231121-3112185.73586.65
330653-3065384.44685.34
430728-3072884.65285.55
530145-3014583.04683.91
630701-3070184.57885.48
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.146598866159658416580065712659000.27
210.146710167039670700.07
单位质量响应值RSD%判断
6499.016614.401.25数据可信
供试品溶液-2025072321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%
5min114343-1434319.62817.5812.4819.6317.5912.48
210580-1058014.47914.48
312062-1206216.50716.51
414985-1498520.50720.51
512312-1231216.84916.85
612817-1281717.54017.54
10min124491-2449133.51631.706.3833.5531.736.39
220881-2088128.57528.60
322932-2293231.38231.41
425059-2505934.29334.33
522647-2264730.99231.02
622983-2298331.45231.48
15min131650-3165043.31341.224.1543.4041.314.16
228341-2834138.78438.86
329712-2971240.66140.74
431479-3147943.07943.17
529624-2962440.54040.62
629937-2993740.96941.05
20min135475-3547548.54747.612.6748.7147.772.68
233538-3353845.89646.03
334275-3427546.90547.05
436175-3617549.50549.67
534542-3454247.27047.42
634758-3475847.56647.72
30min141438-4143856.70856.481.4756.9556.711.48
241211-4121156.39756.61
340927-4092756.00856.23
442272-4227257.84958.09
541351-4135156.58856.81
640449-4044955.35455.58
45min147000-4700064.31964.351.0464.6664.681.04
246945-4694564.24464.55
346757-4675763.98764.31
447881-4788165.52565.87
547128-4712864.49464.81
646431-4643163.54063.86
60min150547-5054769.17369.801.0369.6270.231.03
250989-5098969.77870.19
350670-5067069.34169.77
451759-5175970.83271.28
551528-5152870.51670.94
650548-5054869.17469.60
90min154837-5483775.04475.770.9475.6076.320.93
255754-5575476.29976.83
355190-5519075.52776.07
455961-5596176.58277.15
555712-5571276.24176.79
654738-5473874.90875.45
120min157175-5717578.24379.481.4078.9380.161.39
258650-5865080.26280.92
358067-5806779.46480.13
459000-5900080.74181.44
558543-5854380.11680.79
657046-5704678.06778.73
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157940-5794079.29080.541.1280.1081.341.12
259124-5912480.91181.70
358889-5888980.58981.39
459784-5978481.81482.65
559077-5907780.84681.65
658285-5828579.76380.56
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数10000
标示量(mg)1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%
110.146679866270665326625765997663710.46
210.146512764928650280.22
单位质量响应值RSD%判断
6545.466413.021.45数据可信
供试品溶液-2025072321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%
5min114166-1416619.61818.0312.4519.6218.0312.44
212828-1282817.76517.77
314134-1413419.57419.57
413455-1345518.63418.63
513655-1365518.91118.91
69868-986813.66613.67
10min124199-2419933.51332.176.5933.5532.206.60
222905-2290531.72131.75
324466-2446633.88333.92
423903-2390333.10333.13
523601-2360132.68532.72
620310-2031028.12728.15
15min130979-3097942.90341.543.9142.9941.623.92
229442-2944240.77440.86
330891-3089142.78142.87
430438-3043842.15342.24
530326-3032641.99842.08
627880-2788038.61138.68
20min135752-3575249.51348.343.5849.6748.493.59
234770-3477048.15348.30
335893-3589349.70849.87
435302-3530248.88949.05
535203-3520348.75248.91
632493-3249344.99945.13
30min141629-4162957.65257.181.6257.8957.411.64
241178-4117857.02757.26
341675-4167557.71557.96
441727-4172757.78758.03
541532-4153257.51757.75
639985-3998555.37555.58
45min147854-4785466.27365.641.3166.6165.971.32
247159-4715965.31065.64
347581-4758165.89466.23
447884-4788466.31466.65
547661-4766166.00566.34
646254-4625464.05764.36
60min151527-5152771.35970.981.2071.8171.421.21
251001-5100170.63171.07
351316-5131671.06771.52
451382-5138271.15871.60
552052-5205272.08672.53
650220-5022069.54969.96
90min155917-5591777.43977.220.8678.0177.780.87
255387-5538776.70577.26
355854-5585477.35277.92
456071-5607177.65278.22
556326-5632678.00578.57
655020-5502076.19776.72
120min158840-5884081.48781.100.7482.1881.780.76
258174-5817480.56581.24
358723-5872381.32582.02
458778-5877881.40182.09
558977-5897781.67782.37
657880-5788080.15780.81
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159528-5952882.44082.020.8383.2782.840.84
258739-5873981.34782.16
359282-5928282.09982.93
459049-5904981.77682.60
560001-6000183.09583.92
658745-5874581.35582.14
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