奥美沙坦酯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100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063857538444386193861038519385530.19
2 16.013853438670386020.25
单位质量响应值RSD%判断
2400.562411.120.32数据可信
供试品溶液-410453批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128613-2861377.10979.783.3177.1179.783.31
228692-2869277.32177.32
329185-2918578.65078.65
431139-3113983.91683.92
529761-2976180.20280.20
630243-3024381.50181.50
10min132091-3209186.48188.272.1686.6188.402.16
232121-3212186.56286.69
332589-3258987.82387.95
433751-3375190.95591.09
532477-3247787.52287.66
633491-3349190.25490.39
15min132869-3286988.57889.772.0588.8590.052.05
232743-3274388.23888.51
333050-3305089.06689.34
434581-3458193.19293.48
533060-3306089.09389.37
633566-3356690.45690.74
20min133273-3327389.66790.251.9990.0990.682.00
232834-3283488.48488.90
333199-3319989.46789.89
434726-3472693.58294.03
533203-3320389.47889.91
633704-3370490.82891.27
30min133347-3334789.86690.711.9490.4491.291.94
233041-3304189.04189.61
333395-3339589.99590.57
434817-3481793.82894.43
533339-3333989.84590.42
634013-3401391.66192.25
45min133513-3351390.31390.812.1791.0391.542.17
232952-3295288.80289.52
333432-3343290.09590.82
435047-3504794.44795.21
533340-3334089.84790.57
633908-3390891.37892.12
60min133535-3353590.37391.252.1491.2492.132.14
233159-3315989.35990.22
333612-3361290.58091.46
435209-3520994.88495.80
533563-3356390.44891.32
634078-3407891.83692.73
极限136700-3670098.90299.761.5099.92100.791.51
236583-3658398.58799.60
336631-3663198.71699.74
438045-38045102.527103.60
536955-3695599.589100.62
637193-37193100.231101.28
奥美沙坦酯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100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.044511244515134514684510174503314510910.11
2 11.084520434520944520680.01
单位质量响应值RSD%判断
40859.6940800.360.11数据可信
供试品溶液-410453批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128579-12857928.28529.374.6428.2929.374.63
2129129-12912928.40628.41
3134145-13414529.51029.51
4144302-14430231.74431.74
5128635-12863528.29828.30
6136280-13628029.98029.98
10min1223393-22339349.14350.002.4749.1950.052.46
2222099-22209948.85948.91
3229757-22975750.54350.59
4236427-23642752.01052.06
5222748-22274849.00149.05
6229295-22929550.44250.49
15min1275361-27536160.57561.062.1860.7061.192.18
2272623-27262359.97360.10
3279852-27985261.56361.70
4288520-28852063.47063.61
5272487-27248759.94360.07
6276450-27645060.81560.95
20min1308114-30811467.78167.741.9568.0167.981.95
2303187-30318766.69766.93
3309330-30933068.04868.28
4318809-31880970.13370.38
5302237-30223766.48866.72
6305941-30594167.30367.54
30min1342072-34207275.25175.071.8175.5975.411.82
2336182-33618273.95574.29
3342534-34253475.35275.70
4352464-35246477.53777.90
5336170-33617073.95274.29
6337965-33796574.34774.69
45min1364842-36484280.26080.311.7380.7380.781.73
2358512-35851278.86779.33
3366600-36660080.64781.12
4376576-37657682.84183.33
5361457-36145779.51579.98
6362338-36233879.70980.18
60min1376099-37609982.73682.891.7383.3483.491.74
2368479-36847981.06081.65
3378493-37849383.26383.87
4388188-38818885.39686.03
5374465-37446582.37782.97
6374968-37496882.48783.09
极限1429610-42961094.50895.180.8995.2595.920.90
2428485-42848594.26094.99
3433449-43344995.35296.10
4439381-43938196.65797.43
5433325-43332595.32596.06
6431743-43174394.97795.72
奥美沙坦酯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100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.067733177417773537727577347773450.07
2 16.017759177742776660.14
单位质量响应值RSD%判断
4816.004851.090.52数据可信
供试品溶液-410314批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158031-5803177.84079.713.9377.8479.713.93
257960-5796077.74577.74
359591-5959179.93379.93
463600-6360085.31085.31
560196-6019680.74480.74
657174-5717476.69176.69
10min164389-6438986.36887.112.7986.5087.252.79
264182-6418286.09186.22
365710-6571088.14088.27
466613-6661389.35289.49
566788-6678889.58689.72
661990-6199083.15083.28
15min165575-6557587.95988.322.5988.2388.602.59
265585-6558587.97388.25
366373-6637389.03089.31
466963-6696389.82190.11
567756-6775690.88591.17
662816-6281684.25884.52
20min166473-6647389.16489.022.4689.5889.442.46
266503-6650389.20489.62
366459-6645989.14589.57
467059-6705989.95090.39
568327-6832791.65192.09
663377-6337785.01185.42
30min167883-6788391.05589.932.4291.6290.502.42
266844-6684489.66190.23
366901-6690189.73890.31
467299-6729990.27290.86
569116-6911692.70993.30
664214-6421486.13486.68
45min169664-6966493.44490.772.4894.1691.492.48
267184-6718490.11790.84
367499-6749990.54091.27
467647-6764790.73991.48
569122-6912292.71793.46
664890-6489087.04087.73
60min170831-7083195.00991.412.5595.8992.292.54
267424-6742490.43991.31
368490-6849091.86992.75
467519-6751990.56791.46
568955-6895592.49393.39
665664-6566488.07988.92
极限172157-7215796.78897.660.8797.8298.690.88
272946-7294697.84698.87
372239-7223996.89897.93
473512-7351298.60699.65
573575-7357598.69099.74
672428-7242897.15298.14
奥美沙坦酯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100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.044564314565484563294568924562344564870.06
2 11.084587314587734587520.01
单位质量响应值RSD%判断
41348.4641403.610.10数据可信
供试品溶液-410314批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126297-12629727.41729.715.8627.4229.715.86
2134900-13490029.28429.28
3142062-14206230.83930.84
4149323-14932332.41532.42
5136552-13655229.64329.64
6132055-13205528.66728.67
10min1222389-22238948.27750.013.8448.3250.063.84
2227166-22716649.31449.36
3239317-23931751.95152.00
4241442-24144252.41352.47
5232183-23218350.40350.45
6219873-21987347.73147.78
15min1273765-27376559.43060.683.1259.5660.813.12
2277271-27727160.19160.32
3287871-28787162.49262.63
4289117-28911762.76262.90
5282495-28249561.32561.46
6266498-26649857.85257.98
20min1305734-30573466.36967.432.7366.5967.662.73
2310150-31015067.32867.56
3317945-31794569.02069.26
4317921-31792169.01569.26
5315571-31557168.50568.74
6296387-29638764.34064.56
30min1345262-34526274.95075.192.0975.2975.542.09
2345456-34545674.99275.34
3351753-35175376.35976.72
4349888-34988875.95476.32
5352764-35276476.57976.93
6333095-33309572.30972.64
45min1377316-37731681.90980.901.8582.3781.371.85
2370416-37041680.41180.88
3377224-37722481.88982.37
4372429-37242980.84881.34
5378362-37836282.13682.61
6360124-36012478.17778.63
60min1396450-39645086.06283.822.1586.6684.432.14
2381500-38150082.81783.42
3392214-39221485.14385.76
4382033-38203382.93383.55
5390371-39037184.74385.36
6374220-37422081.23781.82
极限1422210-42221091.65492.240.5692.3992.980.57
2424007-42400792.04492.78
3425161-42516192.29593.06
4426260-42626092.53393.29
5428742-42874293.07293.83
6423060-42306091.83992.56
奥美沙坦酯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100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063891038998390293906438967389940.16
2 16.013896138969389650.02
单位质量响应值RSD%判断
2428.022433.790.17数据可信
供试品溶液-SD018YD批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132235-3223585.97378.089.9185.9778.089.91
226167-2616769.78969.79
325971-2597169.26769.27
431422-3142283.80583.80
528022-2802274.73774.74
631835-3183584.90684.91
10min135972-3597295.94093.355.5596.0893.485.55
233480-3348089.29489.41
331833-3183384.90185.02
436023-3602396.07696.22
537016-3701698.72598.85
635679-3567995.15995.30
15min136440-3644097.18895.464.9797.4995.744.97
234922-3492293.14093.40
332802-3280287.48687.74
436333-3633396.90397.20
538081-38081101.565101.85
636168-3616896.46396.76
20min136778-3677898.09096.164.7798.5696.604.77
235554-3555494.82595.25
333041-3304188.12388.53
436519-3651997.39997.86
538220-38220101.936102.39
636209-3620996.57297.03
30min137024-3702498.74696.614.7699.3797.224.75
235819-3581995.53296.11
333265-3326588.72089.27
436529-3652997.42698.05
538494-38494102.667103.29
636211-3621196.57897.20
45min137124-3712499.01396.984.2999.8197.754.29
236102-3610296.28797.02
333813-3381390.18290.88
436381-3638197.03197.82
538587-38587102.915103.71
636173-3617396.47697.26
60min137262-3726299.38197.164.39100.3498.084.40
236329-3632996.89297.79
333762-3376290.04690.89
436410-3641097.10898.06
538642-38642103.061104.03
636162-3616296.44797.39
极限137944-37944101.20099.663.05102.32100.753.05
237912-37912101.114102.17
336076-3607696.21897.22
436916-3691698.45899.57
539053-39053104.157105.30
636308-3630896.83697.94
奥美沙坦酯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100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.042279752277952279942276992276962278320.07
2 11.082282112282452282280.02
单位质量响应值RSD%判断
20636.9620598.190.14数据可信
供试品溶液-SD018YD批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1106867-10686746.55641.5713.7446.5641.5813.74
285643-8564337.31037.31
387699-8769938.20638.21
4107346-10734646.76546.77
578126-7812634.03534.04
6106887-10688746.56546.57
10min1159328-15932869.41166.805.7669.4966.885.76
2143850-14385062.66862.73
3144322-14432262.87462.94
4162953-16295370.99071.07
5148290-14829064.60264.66
6161327-16132770.28270.36
15min1178494-17849477.76175.994.0777.9576.174.08
2168177-16817773.26673.43
3163673-16367371.30471.47
4182029-18202979.30179.50
5175117-17511776.28976.45
6179102-17910278.02578.22
20min1186623-18662381.30280.033.6481.6280.333.64
2180022-18002278.42678.71
3171808-17180874.84875.14
4189998-18999882.77283.10
5187084-18708481.50381.79
6186628-18662881.30481.63
30min1196559-19655985.63184.303.3586.0984.743.35
2190909-19090983.16983.59
3181588-18158879.10879.52
4197997-19799786.25786.72
5198845-19884586.62687.05
6195176-19517685.02885.49
45min1204042-20404288.89187.633.2589.4988.213.24
2199595-19959586.95387.51
3189272-18927282.45683.00
4204553-20455389.11389.72
5208143-20814390.67791.25
6201298-20129887.69588.30
60min1208879-20887990.99889.653.3291.7590.383.31
2204824-20482489.23189.93
3193877-19387784.46285.14
4207488-20748890.39291.15
5214537-21453793.46394.19
6205142-20514289.37090.12
极限1228223-22822399.42597.522.38100.3398.402.36
2225612-22561298.28799.14
3217753-21775394.86495.69
4220970-22097096.26597.17
5231164-231164100.706101.58
6219401-21940195.58296.48
奥美沙坦酯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100374-202106对照品来源中检所对照品使用方法直接使用
对照品含量(%) 99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063904439186392783919039127391650.23
2 16.013944239425394340.04
单位质量响应值RSD%判断
2438.672463.090.71数据可信
供试品溶液-SD005YD批-氨氯地平-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130916-3091681.78582.979.1781.7982.979.17
234554-3455491.40991.41
332246-3224685.30485.30
428154-2815474.47974.48
534304-3430490.74890.75
628010-2801074.09874.10
10min134725-3472591.86293.713.8892.0093.853.88
237046-3704698.00298.15
334733-3473391.88392.03
434218-3421890.52190.64
537300-3730098.67498.83
634514-3451491.30491.43
15min135782-3578294.65895.663.0494.9595.953.05
237331-3733198.75699.07
335260-3526093.27793.57
435455-3545593.79394.07
537763-3776399.899100.21
635366-3536693.55893.83
20min136552-3655296.69596.762.6597.1497.222.66
237362-3736298.83899.32
335598-3559894.17194.62
435657-3565794.32794.76
538048-38048100.653101.13
636249-3624995.89396.33
30min137431-3743199.02097.492.6299.6398.102.62
237297-3729798.66699.31
335604-3560494.18794.79
435782-3578294.65895.25
538027-38027100.597101.25
636967-3696797.79398.38
45min137810-37810100.02398.232.87100.8099.012.87
237691-3769199.708100.52
335821-3582194.76195.53
435911-3591194.99995.75
538423-38423101.645102.46
637135-3713598.23798.99
60min137720-3772099.78598.013.07100.7298.953.07
237808-37808100.018100.99
335579-3557994.12195.04
435710-3571094.46895.37
538244-38244101.171102.16
637230-3723098.48999.41
极限137634-3763499.55799.133.12100.66100.243.12
238759-38759102.533103.68
337105-3710598.15899.24
435630-3563094.25695.32
538668-38668102.293103.45
637044-3704497.99799.08
奥美沙坦酯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100864-202205对照品来源原料药对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
1 11.042284602288012286262287922284282286210.08
2 11.082309832310432310130.02
单位质量响应值RSD%判断
20708.4220849.550.49数据可信
供试品溶液-SD005YD批-奥美沙坦酯-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105708-10570845.69446.4710.2745.6946.4710.27
2119344-11934451.58951.59
3115680-11568050.00550.00
498534-9853442.59342.59
5114609-11460949.54249.54
691153-9115339.40339.40
10min1160529-16052969.39271.092.8669.4771.172.87
2169182-16918273.13273.22
3164291-16429171.01871.10
4165542-16554271.55971.63
5169545-16954573.28973.37
6157700-15770068.16968.23
15min1180154-18015477.87579.092.1878.0779.282.18
2184095-18409579.57879.79
3181076-18107678.27378.48
4187375-18737580.99681.19
5187348-18734880.98581.19
6177702-17770276.81576.99
20min1191415-19141582.74382.901.8483.0683.221.84
2190610-19061082.39582.74
3188114-18811481.31681.65
4196586-19658684.97885.30
5195409-19540984.46984.81
6188483-18848381.47581.78
30min1204698-20469888.48587.182.0788.9487.652.05
2198215-19821585.68286.16
3195200-19520084.37984.85
4205684-20568488.91189.38
5204382-20438288.34888.83
6201915-20191587.28287.72
45min1214943-21494392.91390.462.5093.5291.072.48
2205620-20562088.88389.50
3200563-20056386.69787.31
4211034-21103491.22391.84
5211561-21156191.45192.08
6211846-21184691.57492.16
60min1219987-21998795.09392.162.8195.8692.922.79
2210505-21050590.99591.76
3203105-20310587.79688.55
4212353-21235391.79492.56
5216349-21634993.52194.30
6216852-21685293.73894.48
极限1224681-22468197.12396.362.1998.0497.272.17
2228694-22869498.85799.78
3221994-22199495.96196.86
4214833-21483392.86693.79
5226337-22633797.83898.77
6220904-22090495.49096.39
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