缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.98 1212971212931212801212491211761212590.05
215.951207151207961207560.05
单位质量响应值RSD%判断
7588.177570.910.17数据可信
供试品溶液-24080402批-缬沙坦-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%
5min118951-1895115.78617.4619.3615.7917.4619.35
220294-2029416.90516.91
314102-1410211.74711.75
423623-2362319.67819.68
524411-2441120.33520.33
624390-2439020.31720.32
10min144405-4440536.99038.8115.0237.0238.8415.02
247436-4743639.51439.54
333613-3361328.00028.02
450181-5018141.80141.83
552320-5232043.58343.62
651600-5160042.98343.02
15min155489-5548946.22348.1212.3146.3148.2212.32
257968-5796848.28848.38
344845-4484537.35637.42
460998-6099850.81250.91
564147-6414753.43553.54
663180-6318052.62952.73
20min161864-6186451.53353.8511.8851.7054.0311.89
265439-6543954.51154.69
350642-5064242.18542.31
468573-6857357.12257.31
571640-7164059.67759.87
669745-6974558.09858.29
30min172205-7220560.14762.3910.9560.4062.6610.97
275623-7562362.99463.26
359801-5980149.81550.01
479208-7920865.98166.26
580914-8091467.40267.70
681664-8166468.02768.32
45min181735-8173568.08671.189.8068.4471.549.81
288029-8802973.32973.70
370197-7019758.47558.76
489569-8956974.61275.00
593213-9321377.64778.05
689923-8992374.90675.31
60min186982-8698272.45777.407.9772.9277.897.99
295465-9546579.52380.02
380936-8093667.42067.80
496732-9673280.57881.10
5100533-10053383.74584.28
696884-9688480.70581.23
90min195082-9508279.20482.935.1779.7983.545.19
296170-9617080.11080.74
395327-9532779.40879.90
499401-9940182.80283.45
5107672-10767289.69190.37
6103669-10366986.35787.02
120min199591-9959182.96087.423.2183.6888.183.23
2107233-10723389.32690.08
3104004-10400486.63687.26
4105087-10508787.53888.33
5109558-10955891.26392.09
6104232-10423286.82687.63
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1102804-10280485.63690.002.8886.4990.902.86
2107415-10741589.47790.38
3110864-11086492.35093.12
4107875-10787589.86190.80
5111543-11154392.91693.89
6107742-10774289.75090.70
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.98 1215741216261216751216291215471216100.05
215.951207601208161207880.04
单位质量响应值RSD%判断
7610.147572.920.35数据可信
供试品溶液-24080403批-缬沙坦-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%
5min126752-2675222.25023.7815.5822.2523.7815.58
233513-3351327.87327.87
323658-2365819.67619.68
434660-3466028.82728.83
525615-2561521.30421.30
627351-2735122.74822.75
10min144176-4417636.74142.0311.3436.7842.0711.34
255945-5594546.52946.58
344835-4483537.28937.32
458210-5821048.41348.46
551103-5110342.50242.54
648925-4892540.69140.73
15min155309-5530946.00049.9510.4046.1050.0610.41
266025-6602554.91355.04
354851-5485145.61945.71
469450-6945057.76157.89
559173-5917349.21449.32
655506-5550646.16446.27
20min160432-6043250.26155.219.0850.4455.409.08
271777-7177759.69759.91
361008-6100850.74050.91
475022-7502262.39562.62
567203-6720355.89256.08
662837-6283752.26152.44
30min162633-6263352.09259.9710.2852.3560.2510.28
278305-7830565.12665.44
366412-6641255.23555.49
482441-8244168.56668.89
573138-7313860.82961.11
669674-6967457.94858.22
45min173724-7372461.31666.188.0361.6666.568.05
284440-8444070.22870.65
372887-7288760.62060.97
489221-8922174.20574.65
580332-8033266.81267.19
676796-7679663.87164.24
60min180573-8057367.01270.446.6867.4670.946.70
288346-8834673.47774.02
378314-7831465.13365.58
493165-9316577.48578.05
586693-8669372.10272.60
681072-8107267.42767.90
90min190317-9031775.11676.745.9975.6877.356.01
295344-9534479.29779.96
384407-8440770.20170.76
4100429-10042983.52684.22
593789-9378978.00478.62
689327-8932774.29374.88
120min195914-9591479.77182.264.2980.4683.004.33
2101615-10161584.51385.31
393266-9326677.56978.24
4104941-10494187.27988.11
5100517-10051783.59984.34
697222-9722280.85981.57
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198304-9830481.75991.455.6682.5892.335.66
2112286-11228693.38894.32
3109548-10954891.11191.91
4115413-11541395.98896.97
5114652-11465295.35596.24
6109565-10956591.12591.97
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.98 1204411203961205091203721204171204270.05
215.951214921214051214480.06
单位质量响应值RSD%判断
7536.117614.290.73数据可信
供试品溶液-24080404批-缬沙坦-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%
5min152141-5214143.46040.544.7043.4640.544.70
245652-4565238.05138.05
348678-4867840.57340.57
449830-4983041.53441.53
548751-4875140.63440.63
646793-4679339.00239.00
10min169199-6919957.67855.652.6557.7555.722.65
264352-6435253.63853.70
366275-6627555.24155.31
467698-6769856.42756.50
567680-6768056.41256.48
665406-6540654.51654.58
15min179005-7900565.85162.743.7566.0262.903.74
272898-7289860.76160.91
374094-7409461.75861.92
475799-7579963.17963.34
577948-7794864.97065.13
671918-7191859.94460.10
20min184093-8409370.09267.883.5270.3768.153.52
280295-8029566.92667.18
380641-8064167.21567.48
483487-8348769.58769.86
583527-8352769.62069.89
676594-7659463.84164.10
30min192953-9295377.47775.543.4477.8775.913.44
289056-8905674.22974.59
388330-8833073.62374.00
492954-9295477.47877.86
594071-9407178.40978.79
686378-8637871.99672.36
45min1100635-10063583.88082.782.2884.4083.292.28
299237-9923782.71483.20
395861-9586179.90180.40
4101148-10114884.30784.82
5101579-10157984.66785.18
697469-9746981.24181.72
60min1104971-10497187.49486.692.4188.1687.332.40
2104284-10428486.92187.55
399521-9952182.95183.58
4104358-10435886.98387.64
5107155-10715589.31489.97
6103763-10376386.48787.10
90min1107463-10746389.57188.222.9190.3889.012.90
2106900-10690089.10289.87
3100358-10035883.64984.42
4105481-10548187.91988.72
5109479-10947991.25192.06
6105368-10536887.82588.59
120min1108021-10802190.03690.572.4791.0091.502.45
2109075-10907590.91591.84
3103730-10373086.45987.37
4109206-10920691.02491.97
5111090-11109092.59493.55
6110838-11083892.38493.29
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1111620-11162093.03691.542.3594.1592.622.34
2109182-10918291.00492.08
3104880-10488087.41888.47
4111344-11134492.80693.90
5111217-11121792.70093.81
6110710-11071092.27793.34
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.98 1208301209201209541209341207831208840.07
215.951229581231801230690.13
单位质量响应值RSD%判断
7564.717715.921.40数据可信
供试品溶液-24080405批-缬沙坦-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%
5min142416-4241635.05535.989.4535.0635.989.45
247592-4759239.33339.33
348085-4808539.74039.74
439366-3936632.53432.53
545257-4525737.40337.40
638461-3846131.78631.79
10min173794-7379460.98864.663.4661.0564.723.46
281226-8122667.13067.20
380447-8044766.48666.55
478964-7896465.26165.31
578282-7828264.69764.76
676703-7670363.39263.44
15min191310-9131075.46478.302.3475.6278.472.35
295386-9538678.83379.01
398119-9811981.09181.27
494771-9477178.32478.49
593835-9383577.55177.72
695019-9501978.52978.69
20min198184-9818481.14585.222.8281.4385.522.82
2105474-10547487.17087.48
3105972-10597287.58287.89
4103883-10388385.85586.15
5101378-10137883.78584.08
6103803-10380385.78986.08
30min1104411-10441186.29292.083.3286.7192.523.32
2112839-11283993.25793.71
3114734-11473494.82395.28
4112504-11250492.98093.42
5110559-11055991.37391.81
6113472-11347293.78094.21
45min1112424-11242492.91496.562.3493.4897.152.34
2117981-11798197.50798.12
3119639-11963998.87799.49
4118868-11886898.24098.83
5114789-11478994.86995.46
6117287-11728796.93397.52
60min1113194-11319493.55097.622.6194.2798.372.61
2121454-121454100.377101.15
3120340-12034099.456100.24
4116204-11620496.03896.79
5117609-11760997.19997.95
6119902-11990299.09499.84
90min1114242-11424294.41698.912.6695.2999.822.66
2121363-121363100.302101.24
3122531-122531101.267102.21
4121934-121934100.774101.69
5117612-11761297.20298.11
6120366-12036699.478100.39
120min1114222-11422294.40099.283.3795.43100.363.36
2122834-122834101.517102.62
3123341-123341101.936103.05
4123797-123797102.313103.40
5116168-11616896.00897.08
6120383-12038399.492100.57
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1116776-11677696.51199.992.3197.70101.242.32
2122393-122393101.153102.43
3123774-123774102.294103.58
4122969-122969101.629102.88
5118325-11832597.79199.02
6121681-121681100.564101.81
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