缬沙坦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对照品来源中检院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2000
标示量(mg)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%
113.872468162469452472022470832469602470010.06
213.942429962432432431200.08
单位质量响应值RSD%判断
17808.2917440.461.48数据可信
长期3月-供试品溶液-2023112521批-氨氯地平-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%
5min185756-8575631.54631.926.6431.5531.926.64
283301-8330130.64330.64
390515-9051533.29633.30
485901-8590131.59931.60
595831-9583135.25235.25
679298-7929829.17029.17
10min1135512-13551249.84950.392.6349.9050.442.62
2135102-13510249.69849.75
3142166-14216652.29652.35
4131910-13191048.52448.58
5139257-13925751.22651.29
6137965-13796550.75150.80
15min1164063-16406360.35161.523.5360.4961.653.53
2162259-16225959.68859.82
3172697-17269763.52763.67
4160091-16009158.89059.02
5174406-17440664.15664.30
6169869-16986962.48762.62
20min1182481-18248167.12768.534.1267.3668.784.12
2181034-18103466.59466.83
3190889-19088970.21970.47
4175792-17579264.66664.90
5195734-19573472.00272.25
6191918-19191870.59870.84
30min1205450-20545075.57677.003.6375.9277.353.63
2200310-20031073.68574.03
3213968-21396878.70979.07
4203808-20380874.97275.31
5220987-22098781.29181.66
6211384-21138477.75978.11
45min1215278-21527879.19183.903.6079.6784.393.59
2223539-22353982.23082.70
3230902-23090284.93885.44
4227354-22735483.63384.10
5239341-23934188.04388.55
6232098-23209885.37885.86
60min1231714-23171485.23786.702.1785.8487.322.16
2236488-23648886.99387.60
3228757-22875784.14984.79
4237165-23716587.24287.85
5243603-24360389.61190.26
6236464-23646486.98487.61
极限1250448-25044892.12992.831.4892.8893.601.47
2254716-25471693.69994.45
3248176-24817691.29392.07
4254514-25451493.62494.37
5257394-25739494.68495.49
6248852-24885291.54192.31
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014863867486457548551784851502485226748574780.13
216.004759858476313647614970.05
单位质量响应值RSD%判断
303402.75297593.561.37数据可信
长期3月-供试品溶液-2023112521批-缬沙坦-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%
5min13490156-349015664.75067.403.0364.7567.403.03
23648231-364823167.68367.68
33747763-374776369.52969.53
43541895-354189565.71065.71
53764724-376472469.84469.84
63604586-360458666.87366.87
10min14307506-430750679.91482.312.5080.0282.422.50
24382483-438248381.30581.42
34513705-451370583.73983.85
44326540-432654080.26780.38
54557072-455707284.54484.66
64531209-453120984.06484.18
15min14631811-463181185.93087.921.9086.1788.161.90
24691291-469129187.03487.28
34793457-479345788.92989.18
44660936-466093686.47186.71
54855790-485579090.08590.34
64800178-480017889.05489.31
20min14778518-477851888.65290.651.6089.0491.041.60
24844912-484491289.88490.28
34925192-492519291.37391.78
44843210-484321089.85290.24
54995671-499567192.68193.09
64928270-492827091.43091.83
30min14956149-495614991.94793.641.2692.4894.191.26
25107478-510747894.75595.30
35038145-503814593.46994.02
45015949-501594993.05793.59
55130962-513096295.19195.75
65036693-503669393.44293.99
45min15059436-505943693.86494.920.9494.5595.630.94
25108072-510807294.76695.47
35101722-510172294.64895.36
45150515-515051595.55396.25
55193050-519305096.34297.06
65086228-508622894.36195.07
60min15100977-510097794.63495.590.9995.4896.460.99
25161606-516160695.75996.62
35137510-513751095.31296.18
45205606-520560696.57597.43
55214590-521459096.74297.62
65095772-509577294.53895.40
极限15268445-526844597.74197.931.4498.7498.951.42
25373134-537313499.683100.70
35172007-517200795.95296.98
45310652-531065298.52499.54
55333057-533305798.94099.98
65213104-521310496.71497.74
缬沙坦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对照品来源中检院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2000
标示量(mg)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%
113.872435502410942452122454602453032441240.77
213.942433622431672432640.06
单位质量响应值RSD%判断
17600.8717450.790.61数据可信
长期3月-供试品溶液-2023112521批-氨氯地平-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%
5min189482-8948233.09931.409.2633.1031.409.26
270058-7005825.91425.91
383071-8307130.72730.73
487535-8753532.37832.38
592145-9214534.08434.08
687049-8704932.19932.20
10min1141939-14193952.50247.928.7652.5647.978.75
2108362-10836240.08240.13
3128920-12892047.68647.74
4131221-13122148.53748.59
5135295-13529550.04450.10
6131574-13157448.66848.72
15min1172818-17281863.92459.814.9564.0759.954.96
2151212-15121255.93256.04
3156072-15607257.72957.86
4158301-15830158.55458.69
5167905-16790562.10662.25
6163930-16393060.63660.77
20min1190023-19002370.28868.183.3870.5468.423.39
2174448-17444864.52764.73
3181868-18186867.27167.50
4181370-18137067.08767.32
5190177-19017770.34570.59
6188110-18811069.58069.82
30min1214649-21464979.39776.512.8079.7676.862.80
2205190-20519075.89876.21
3209113-20911377.34977.69
4203979-20397975.45075.79
5210220-21022077.75878.12
6197944-19794473.21873.57
45min1236031-23603187.30685.222.0687.8085.692.06
2229728-22972884.97485.41
3231150-23115085.50085.97
4221708-22170882.00882.48
5231876-23187685.76986.26
6231823-23182385.74986.22
60min1235516-23551687.11587.722.2987.7688.342.27
2235241-23524187.01387.59
3244636-24463690.48891.10
4228825-22882584.64085.25
5237779-23777987.95288.59
6240930-24093089.11889.73
极限1249895-24989592.43493.071.7793.2293.831.76
2252172-25217293.27694.00
3251386-25138692.98593.75
4245079-24507990.65291.40
5252298-25229893.32394.10
6258810-25881095.73196.50
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014840223482956148243004828333482498748294810.14
216.004809885480930148095930.01
单位质量响应值RSD%判断
301654.03300599.560.25数据可信
长期3月-供试品溶液-2023112521批-缬沙坦-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%
5min13783962-378396270.04863.948.9470.0563.948.94
22872286-287228653.17153.17
33422662-342266263.36063.36
43553808-355380865.78765.79
53571600-357160066.11766.12
63518969-351896965.14265.14
10min14497367-449736783.25477.716.3383.3777.826.33
23707225-370722568.62768.72
34155614-415561476.92877.03
44237404-423740478.44278.55
54284092-428409279.30679.42
64304879-430487979.69179.80
15min14826413-482641389.34585.003.4989.6085.243.50
24332854-433285480.20980.41
34560020-456002084.41484.65
44559519-455951984.40584.65
54621085-462108585.54485.79
64649209-464920986.06586.31
20min15009403-500940392.73388.912.3893.1489.292.40
24672388-467238886.49486.83
34756446-475644688.05088.42
44756043-475604388.04388.42
54788722-478872288.64889.03
64835000-483500089.50489.89
30min15184171-518417195.96893.001.7496.5393.531.74
25031456-503145693.14193.62
35006828-500682892.68593.21
44935859-493585991.37291.90
54960505-496050591.82892.36
65025293-502529393.02793.56
45min15220693-522069396.64494.641.6097.3695.321.59
25182535-518253595.93896.57
35109279-510927994.58295.26
45006544-500654492.68093.36
55038294-503829493.26893.95
65118058-511805894.74495.43
60min15252037-525203797.22595.311.2798.1096.151.27
25195664-519566496.18196.98
35138095-513809595.11595.95
45121510-512151094.80895.64
55066994-506699493.79994.64
65117834-511783494.74095.59
极限15251843-525184397.22196.561.0398.2697.561.03
25229290-522929096.80397.76
35129263-512926394.95295.94
45208505-520850596.41997.41
55192076-519207696.11597.11
65285411-528541197.84298.85
缬沙坦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对照品来源中检院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2000
标示量(mg)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%
113.872324792315812321722324422324602322270.17
213.942371042369832370440.04
单位质量响应值RSD%判断
16743.1117004.591.10数据可信
加速3月-供试品溶液-2023112521批-氨氯地平-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%
5min180379-8037930.88129.896.0830.8829.896.08
268437-6843726.29326.29
378428-7842830.13230.13
479956-7995630.71930.72
581235-8123531.21031.21
678426-7842630.13130.13
10min1123332-12333247.38448.183.3147.4448.233.31
2118522-11852245.53645.58
3126832-12683248.72948.78
4126407-12640748.56548.62
5130895-13089550.29050.34
6126363-12636348.54848.60
15min1152854-15285458.72659.613.9758.8659.743.97
2144043-14404355.34155.46
3158081-15808160.73460.87
4156162-15616259.99760.13
5161574-16157462.07662.21
6158237-15823760.79460.93
20min1170487-17048765.50167.273.9365.7367.503.92
2163909-16390962.97463.19
3174615-17461567.08767.32
4181292-18129269.65269.88
5180379-18037969.30169.54
6179912-17991269.12269.35
30min1190700-19070073.26775.014.1373.6075.354.12
2183325-18332570.43370.75
3193531-19353174.35474.70
4195888-19588875.26075.61
5202261-20226177.70878.06
6205661-20566179.01579.36
45min1195964-19596475.28981.794.7775.7582.264.75
2206777-20677779.44379.88
3216334-21633483.11583.58
4216514-21651483.18483.66
5216555-21655583.20083.68
6225198-22519886.52187.00
60min1208756-20875680.20485.164.1180.7985.764.10
2215242-21524282.69683.26
3222343-22234385.42486.03
4220279-22027984.63185.24
5230272-23027288.47089.09
6233054-23305489.53990.16
极限1233047-23304789.53693.162.5390.2593.902.52
2246439-24643994.68195.39
3239724-23972492.10192.85
4240485-24048592.39493.15
5244490-24449093.93394.70
6250669-25066996.30797.08
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014666688465283446632384665622466790946632580.14
216.004747559474172747446430.09
单位质量响应值RSD%判断
291271.58296540.191.27数据可信
加速3月-供试品溶液-2023112521批-缬沙坦-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%
5min13487377-348737766.14965.852.3566.1565.852.35
23381874-338187464.14864.15
33432242-343224265.10365.10
43601178-360117868.30768.31
53520250-352025066.77266.77
63407647-340764764.63664.64
10min14088970-408897077.56079.892.5977.6780.002.59
24076620-407662077.32677.43
34193589-419358979.54479.65
44307990-430799081.71481.83
54299705-429970581.55781.67
64303482-430348281.62981.74
15min14335177-433517782.23085.712.9282.4785.962.91
24387703-438770383.22683.46
34524663-452466385.82486.07
44583550-458355086.94187.19
54612604-461260487.49287.74
64669483-466948388.57188.81
20min14452629-445262984.45888.512.9284.8388.902.92
24568887-456888786.66387.04
34679466-467946688.76089.14
44707831-470783189.29889.69
54757856-475785690.24790.64
64831710-483171091.64892.04
30min14559723-455972386.48991.363.0787.0191.903.06
24787355-478735590.80791.33
34830051-483005191.61792.15
44825939-482593991.53992.08
54887243-488724392.70193.24
65009047-500904795.01295.56
45min14630890-463089087.83992.763.1488.5093.443.13
24849191-484919191.98092.65
34921265-492126593.34794.03
44882774-488277492.61793.31
54959398-495939894.07094.77
65097090-509709096.68297.38
60min14690025-469002588.96193.763.0389.7794.603.02
24914663-491466393.22294.05
34986364-498636494.58295.42
44916632-491663293.25994.11
55006353-500635394.96195.82
65144295-514429597.57798.44
极限15061296-506129696.00398.102.1996.9699.102.17
25311606-5311606100.751101.73
35148773-514877397.66298.66
45059085-505908595.96196.97
55143527-514352797.56398.58
65305965-5305965100.644101.67
缬沙坦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对照品来源中检院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2000
标示量(mg)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%
113.872363082361702365202365542364232363950.07
213.942360502359542360020.03
单位质量响应值RSD%判断
17043.6216929.840.48数据可信
加速3月-供试品溶液-2023112521批-氨氯地平-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%
5min176135-7613529.05530.532.8429.0630.532.84
281681-8168131.17231.17
381930-8193031.26731.27
479237-7923730.23930.24
581743-8174331.19531.20
679195-7919530.22330.22
10min1117696-11769644.91648.124.0044.9648.174.01
2128504-12850449.04149.09
3132105-13210550.41550.47
4125656-12565647.95448.00
5123642-12364247.18547.24
6129001-12900149.23049.28
15min1147213-14721356.18059.773.3756.3059.903.37
2158245-15824560.39060.52
3162621-16262162.06062.20
4155544-15554459.36059.49
5156248-15624859.62859.76
6159823-15982360.99361.13
20min1162426-16242661.98666.023.3862.2066.253.38
2178622-17862268.16768.40
3177908-17790867.89468.13
4171586-17158665.48265.71
5173394-17339466.17266.40
6174108-17410866.44466.68
30min1184651-18465170.46874.263.4370.7974.603.43
2194172-19417274.10174.45
3204250-20425077.94778.30
4190990-19099072.88773.23
5194793-19479374.33874.68
6198709-19870975.83376.18
45min1193075-19307573.68380.884.8174.1281.354.80
2220798-22079884.26284.73
3219822-21982283.89084.37
4210613-21061380.37580.84
5211092-21109280.55881.02
6216289-21628982.54283.01
60min1205018-20501878.24083.163.9478.8083.763.94
2226123-22612386.29486.91
3227229-22722986.71787.34
4214093-21409381.70482.30
5213451-21345181.45982.06
6221598-22159884.56885.18
极限1236473-23647390.24491.011.9590.9491.751.95
2237687-23768790.70891.46
3245658-24565893.75094.52
4231858-23185888.48389.21
5238165-23816590.89091.62
6241111-24111192.01492.76
缬沙坦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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014754045475719247560424756470475438647556270.03
216.004750607474769547491510.05
单位质量响应值RSD%判断
297041.04296821.940.06数据可信
加速3月-供试品溶液-2023112521批-缬沙坦-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%
5min13349598-334959862.88365.312.5062.8865.312.50
23554681-355468166.73366.73
33484630-348463065.41865.42
43406992-340699263.96063.96
53499040-349904065.68865.69
63577505-357750567.16167.16
10min14072363-407236376.45279.012.7676.5679.122.76
24343885-434388581.54981.66
34297311-429731180.67580.78
44098887-409888776.95077.06
54147813-414781377.86877.98
64291105-429110580.55880.67
15min14384611-438461182.31384.472.7882.5584.712.77
24631282-463128286.94487.19
34598436-459843686.32886.57
44357202-435720281.79982.03
54420697-442069782.99183.23
64603821-460382186.42986.67
20min14536700-453670085.16987.132.7485.5487.512.74
24777347-477734789.68690.08
34741468-474146889.01389.40
44496787-449678784.41984.79
54547741-454774185.37685.75
64747404-474740489.12489.51
30min14659830-465983087.48089.772.7787.9990.302.77
24904012-490401292.06492.61
34887009-488700991.74592.28
44627914-462791486.88187.39
54701904-470190488.27088.79
64909562-490956292.16992.71
45min14750688-475068889.18691.292.8389.8491.972.83
24968473-496847393.27493.97
35007887-500788794.01494.70
44721903-472190388.64689.30
54742176-474217689.02689.69
64986216-498621693.60894.30
60min14814251-481425190.37992.092.6091.1992.922.60
24997986-499798693.82994.68
35025461-502546194.34495.19
44764621-476462189.44890.25
54793182-479318289.98490.80
65037156-503715694.56495.41
极限15121137-512113796.14195.812.0897.1096.802.08
25071688-507168895.21296.22
35126285-512628596.23797.24
44984523-498452393.57694.53
55029594-502959494.42295.39
65289462-528946299.301100.31
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