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5000
标示量(mg)2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%
110.096558965592654496575465352655470.24
210.126702667195671100.18
单位质量响应值RSD%判断
6496.236631.421.46数据可信
供试品溶液-2025072121批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122547-2254730.82334.327.8330.8234.327.83
225168-2516834.40634.41
325652-2565235.06735.07
423036-2303631.49131.49
527387-2738737.43937.44
626826-2682636.67236.67
10min139438-3943853.91455.023.1253.9655.083.12
239685-3968554.25154.31
340592-4059255.49155.55
438556-3855652.70852.76
541878-4187857.24957.31
641357-4135756.53756.60
15min148270-4827065.98765.431.7866.1365.581.78
246677-4667763.81063.96
347853-4785365.41765.57
447028-4702864.28964.43
548772-4877266.67466.83
648570-4857066.39766.55
20min153121-5312172.61971.431.8372.8771.691.83
250670-5067069.26869.52
352141-5214171.27971.54
451724-5172470.70970.96
553143-5314372.64972.92
652715-5271572.06472.33
30min158319-5831979.72577.542.1780.1077.922.17
254723-5472374.80975.18
356767-5676777.60377.98
456036-5603676.60476.97
557121-5712178.08778.48
657343-5734378.39078.78
45min161420-6142083.96482.241.6584.4782.751.65
258408-5840879.84680.34
360278-6027882.40382.91
460349-6034982.50082.99
559945-5994581.94882.47
660570-6057082.80283.32
60min163006-6300686.13284.371.2486.7885.021.24
260671-6067182.94083.57
361407-6140783.94684.59
461746-6174684.41085.04
561578-6157884.18084.84
661898-6189884.61785.27
90min164854-6485488.65886.501.3389.4587.281.33
262434-6243485.35086.12
363065-6306586.21387.00
462813-6281385.86886.64
563072-6307286.22287.02
663396-6339686.66587.46
120min164920-6492088.74987.270.9289.6888.200.91
263483-6348386.78487.69
363293-6329386.52487.45
463934-6393487.40188.31
563547-6354786.87287.81
663870-6387087.31388.25
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165127-6512789.03287.760.8990.1288.840.88
263753-6375387.15388.21
364269-6426987.85988.93
464186-6418687.74588.81
563483-6348386.78487.87
664368-6436887.99489.08
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5000
标示量(mg)2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%
110.096648266765663826618365981663590.45
210.126809267734679130.38
单位质量响应值RSD%判断
6576.716710.771.43数据可信
供试品溶液-2025072221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128453-2845338.42936.9312.9438.4336.9312.93
229338-2933839.62439.62
329161-2916139.38539.38
427503-2750337.14537.15
520269-2026927.37527.38
629335-2933539.62039.62
10min142787-4278757.78856.217.0057.8556.277.00
242300-4230057.13057.20
342955-4295558.01558.08
442366-4236657.21957.28
535749-3574948.28248.33
643547-4354758.81458.88
15min149713-4971367.14265.894.2067.3066.044.21
249071-4907166.27566.44
349630-4963067.03067.19
449061-4906166.26266.42
544746-4474660.43460.56
650474-5047468.17068.33
20min153611-5361172.40771.072.8272.6871.342.84
252619-5261971.06771.34
353034-5303471.62871.90
453137-5313771.76772.03
549698-4969867.12267.35
653639-5363972.44572.72
30min157270-5727077.34976.571.4077.7476.951.41
256350-5635076.10676.50
356464-5646476.26076.65
456935-5693576.89677.28
555444-5544474.88275.22
657690-5769077.91678.31
45min160061-6006181.11880.360.7681.6480.870.77
259078-5907879.79180.31
359050-5905079.75380.27
459564-5956480.44780.96
559238-5923880.00780.47
659991-5999181.02481.55
60min161406-6140682.93582.451.4183.5983.101.41
261220-6122082.68483.33
359952-5995280.97181.62
460638-6063881.89782.55
560630-6063081.88782.48
662448-6244884.34285.01
90min163735-6373586.08084.662.0986.8885.442.07
263793-6379386.15986.95
360246-6024681.36882.16
462965-6296585.04085.83
562397-6239784.27385.01
662951-6295185.02185.83
120min165544-6554488.52485.642.5589.4686.562.53
264181-6418186.68387.61
360638-6063881.89782.82
463447-6344785.69186.62
562996-6299685.08285.96
663633-6363385.94386.89
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165698-6569888.73286.871.7589.8287.941.75
265511-6551188.47989.55
362715-6271584.70385.76
464094-6409486.56587.64
563729-6372986.07287.09
664166-6416686.66287.75
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5000
标示量(mg)2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%
110.096784468174683816806067846680610.34
210.126842468267683460.17
单位质量响应值RSD%判断
6745.396753.560.09数据可信
供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128691-2869138.13934.686.4238.1434.686.43
226176-2617634.79634.80
326274-2627434.92634.93
426863-2686335.70935.71
524272-2427232.26532.26
624271-2427132.26432.26
10min142996-4299657.15553.264.2257.2253.314.22
239414-3941452.39352.45
339884-3988453.01853.08
440874-4087454.33454.39
538976-3897651.81151.86
638238-3823850.83050.88
15min150393-5039366.98862.643.7967.1562.793.79
246354-4635461.61961.76
346757-4675762.15462.30
447618-4761863.29963.45
546453-4645361.75061.89
645180-4518060.05860.20
20min153731-5373171.42568.192.5871.7068.442.59
250662-5066267.34567.59
350471-5047167.09167.34
451699-5169968.72468.98
551180-5118068.03468.28
650050-5005066.53266.77
30min158099-5809977.23174.322.2377.6274.682.24
255567-5556773.86574.23
355535-5553573.82374.18
456186-5618674.68875.06
555754-5575474.11474.47
654296-5429672.17672.53
45min161051-6105181.15578.851.5681.6779.341.57
259082-5908278.53879.02
359137-5913778.61179.10
459264-5926478.78079.27
559120-5912078.58879.07
658263-5826377.44977.92
60min161471-6147181.71480.890.9282.3781.510.93
261022-6102281.11781.73
360443-6044380.34780.96
461291-6129181.47482.10
560926-6092680.98981.60
659969-5996979.71780.32
90min162951-6295183.68182.950.9384.4783.700.93
262363-6236382.89983.65
361941-6194182.33883.09
462307-6230782.82583.59
563164-6316483.96484.71
661660-6166081.96582.70
120min165641-6564187.25785.571.4488.1986.471.44
264416-6441685.62886.52
364130-6413085.24886.14
465148-6514886.60187.50
563069-6306983.83884.72
663848-6384884.87385.74
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165122-6512286.56785.941.1387.6486.971.14
264944-6494486.33087.36
364475-6447585.70786.74
465611-6561187.21788.26
563569-6356984.50385.53
664164-6416485.29386.30
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