缬沙坦片项目信息
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%
115.444506610450758345045254505016450365745054780.04
215.394497038449662144968300.01
单位质量响应值RSD%判断
291805.57292191.680.10数据可信
供试品溶液-1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%
5min11312576-131257625.05825.002.4425.0625.002.43
21280166-128016624.43924.44
31310864-131086425.02525.02
41267189-126718924.19124.19
51351629-135162925.80325.80
61334902-133490225.48425.48
10min12079012-207901239.68939.602.3439.7339.642.34
22030422-203042238.76238.80
32087769-208776939.85639.90
42005562-200556238.28738.33
52135688-213568840.77140.81
62107494-210749440.23340.28
15min12601340-260134049.66149.632.1049.7749.742.10
22551860-255186048.71648.82
32610043-261004349.82749.93
42523517-252351748.17548.28
52666980-266698050.91451.02
62645542-264554250.50550.61
20min12978683-297868356.86456.952.0957.0557.142.09
22917611-291761155.69855.88
32989753-298975357.07657.27
42910469-291046955.56255.75
53064631-306463158.50558.70
63038060-303806057.99858.19
30min13510312-351031267.01367.181.9767.3067.471.97
23438769-343876965.64865.93
33511826-351182667.04267.33
43456439-345643965.98566.26
53615343-361534369.01869.31
63583009-358300968.40168.69
45min14049244-404924477.30277.501.7677.7077.901.76
23979679-397967975.97476.36
34039433-403943377.11477.51
43999684-399968476.35676.74
54157159-415715979.36279.77
64133498-413349878.91079.31
60min14399344-439934483.98583.991.5684.5184.521.56
24331550-433155082.69183.21
34377658-437765883.57184.10
44328793-432879382.63883.15
54488448-448844885.68686.23
64472590-447259085.38485.92
90min14789153-478915391.42791.001.3692.0991.661.36
24703988-470398889.80190.45
34770295-477029591.06791.73
44676551-467655189.27789.93
54839822-483982292.39493.08
64820600-482060092.02792.71
120min14960693-496069394.70294.201.4195.5295.021.42
24885117-488511793.25994.06
34945928-494592894.42095.24
44820772-482077292.03192.83
55006336-500633695.57396.41
64987847-498784795.22096.05
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15013291-501329195.70695.261.2396.6896.231.23
24944788-494478894.39895.36
34999949-499994995.45196.43
44890934-489093493.37094.32
55049772-504977296.40297.40
65040349-504034996.22297.21
缬沙坦片项目信息
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%
115.444520241452148545219084519969452059545208400.02
215.394503960450662645052930.05
单位质量响应值RSD%判断
292800.52292741.590.02数据可信
供试品溶液-24073103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%
5min11252320-125232023.84422.863.6623.8422.863.65
21206785-120678522.97722.98
31179513-117951322.45822.46
41242955-124295523.66623.67
51188845-118884522.63622.64
61133373-113337321.57921.58
10min12022122-202212238.50137.801.9638.5437.841.96
21981687-198168737.73137.77
31968064-196806437.47237.51
42035869-203586938.76338.80
51976169-197616937.62637.66
61928276-192827636.71436.75
15min12576402-257640249.05548.431.5049.1648.541.50
22552352-255235248.59748.70
32528562-252856248.14448.24
42591334-259133449.33949.44
52528840-252884048.14948.25
62485408-248540847.32247.42
20min13004861-300486157.21356.491.1757.4056.671.18
22981737-298173756.77256.95
32949221-294922156.15356.33
43001507-300150757.14957.34
52945269-294526956.07856.26
62918144-291814455.56255.74
30min13623416-362341668.99067.971.3269.2768.251.32
23614231-361423168.81569.09
33550923-355092367.61067.88
43586077-358607768.27968.56
53547020-354702067.53567.81
63498659-349865966.61566.88
45min14209865-420986580.15679.241.2480.5579.631.24
24236856-423685680.67081.06
34138709-413870978.80179.19
44154114-415411479.09579.49
54129896-412989678.63379.02
64101775-410177578.09878.48
60min14558862-455886286.80185.971.1587.3386.501.15
24599756-459975687.58088.11
34487801-448780185.44885.97
44484137-448413785.37885.91
54491024-449102485.50986.03
64469872-446987285.10785.62
90min14850661-485066192.35792.241.0293.0392.911.02
24937481-493748194.01094.68
34818824-481882491.75192.41
44796563-479656391.32792.00
54841546-484154692.18392.84
64823250-482325091.83592.49
120min14940916-494091694.07594.550.9394.9095.360.93
25049808-504980896.14996.98
34969792-496979294.62595.44
44915069-491506993.58394.40
54968930-496893094.60995.42
64950047-495004794.24995.05
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14950954-495095494.26695.010.8995.2595.990.88
25062197-506219796.38497.37
35007132-500713295.33696.31
44940630-494063094.07095.05
55001028-500102895.22096.19
64978649-497864994.79495.76
缬沙坦片项目信息
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%
115.444495963449464244948824495025449196344944950.04
215.394500579450528345029310.08
单位质量响应值RSD%判断
291094.24292588.110.37数据可信
供试品溶液-1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%
5min1972995-97299518.58518.573.1518.5918.573.15
2993324-99332418.97318.97
3955907-95590718.25918.26
4919199-91919917.55717.56
5993770-99377018.98218.98
6998650-99865019.07519.08
10min11622240-162224030.98630.802.5631.0230.832.57
21619437-161943730.93330.96
31577818-157781830.13830.17
41556111-155611129.72329.75
51624579-162457931.03131.06
61674533-167453331.98532.02
15min12111899-211189940.33940.142.0340.4240.222.03
22134679-213467940.77440.86
32063065-206306539.40639.49
42036923-203692338.90738.99
52116919-211691940.43540.52
62145732-214573240.98541.07
20min12513136-251313648.00347.611.6048.1547.761.60
22531403-253140348.35248.50
32475574-247557447.28647.43
42421001-242100146.24346.39
52497301-249730147.70147.85
62515728-251572848.05348.21
30min13109628-310962859.39758.961.3859.6359.191.38
23150201-315020160.17160.40
33060430-306043058.45758.68
43026205-302620557.80358.02
53078794-307879458.80859.04
63095031-309503159.11859.35
45min13726097-372609771.17271.061.0171.5071.381.01
23789348-378934872.38072.71
33699834-369983470.67070.99
43682540-368254070.34070.66
53702596-370259670.72371.05
63720765-372076571.07071.40
60min14166441-416644179.58379.350.7580.0379.790.75
24201734-420173480.25780.71
34130912-413091278.90479.34
44135178-413517878.98579.42
54119615-411961578.68879.13
64170350-417035079.65780.11
90min14671385-467138589.22788.481.1689.8189.061.16
24652613-465261388.86989.46
34624162-462416288.32588.90
44531063-453106386.54787.11
54637129-463712988.57389.15
64676145-467614589.31889.90
120min14912122-491212293.82693.100.8594.5593.820.84
24819159-481915992.05092.78
34832981-483298192.31493.03
44869985-486998593.02193.73
54894873-489487393.49694.22
64916397-491639793.90794.64
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14717808-471780890.11493.281.8391.0094.161.82
24864445-486444592.91593.80
34898975-489897593.57594.45
44904828-490482893.68694.55
54945691-494569194.46795.35
64970361-497036194.93895.83
缬沙坦片项目信息
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%
115.444520450452041245228884517248452131745204630.05
215.394534942453251645337290.04
单位质量响应值RSD%判断
292776.10294589.280.44数据可信
供试品溶液-2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%
5min1965078-96507818.31818.683.0018.3218.683.01
21026686-102668619.48819.49
3961990-96199018.26018.26
4986339-98633918.72218.72
5953311-95331118.09518.09
61010876-101087619.18819.19
10min11619148-161914830.73331.113.9730.7631.143.97
21705706-170570632.37632.41
31522917-152291728.90728.94
41676875-167687531.82931.86
51633737-163373731.01031.04
61676201-167620131.81631.85
15min12126830-212683040.37040.862.4340.4540.942.43
22217061-221706142.08242.17
32067218-206721839.23839.32
42183549-218354941.44641.53
52146410-214641040.74140.82
62175704-217570441.29741.38
20min12552401-255240148.44749.032.5448.6049.182.54
22709608-270960851.43151.59
32533462-253346248.08848.23
42594905-259490549.25449.41
52543560-254356048.28048.43
62563569-256356948.65948.81
30min13227265-322726561.25760.472.2361.4960.712.23
23252873-325287361.74361.99
33157407-315740759.93160.16
43242762-324276261.55161.79
53171176-317117660.19260.42
63064605-306460558.17058.40
45min13857645-385764573.22273.131.4573.5573.461.45
23921574-392157474.43674.78
33809385-380938572.30672.63
43913431-391343174.28174.62
53829185-382918572.68273.01
63785537-378553771.85472.19
60min14268785-426878581.02680.821.2481.4881.281.24
24277347-427734781.18981.66
34222003-422200380.13880.58
44336878-433687882.31982.78
54261881-426188180.89581.35
64181219-418121979.36479.82
90min14691990-469199089.05988.451.0989.6589.041.09
24610631-461063187.51588.12
34634505-463450587.96888.55
44701615-470161589.24289.84
54719351-471935189.57990.17
64600926-460092687.33187.91
120min14862019-486201992.28792.461.2393.0293.191.22
24881075-488107592.64893.40
34787080-478708090.86491.59
44949359-494935993.94494.69
54919491-491949193.37794.11
64826543-482654391.61392.34
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14963000-496300094.20393.221.5095.0994.111.49
24919634-491963493.38094.29
34808642-480864291.27392.15
44979185-497918594.51195.41
54964298-496429894.22895.12
64832178-483217891.72092.60
缬沙坦片项目信息
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%
115.444502655450217545011194502752450296845023340.02
215.394506907450942745081670.04
单位质量响应值RSD%判断
291601.94292928.330.33数据可信
供试品溶液-24073102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%
5min1868997-86899716.57416.992.4916.5716.982.50
2911142-91114217.37817.38
3917561-91756117.50117.50
4900004-90000417.16617.17
5865670-86567016.51116.51
6879857-87985716.78216.78
10min11484236-148423628.30928.402.5928.3428.432.59
21528180-152818029.14729.18
31518384-151838428.96028.99
41496834-149683428.54928.58
51418722-141872227.05927.09
61487586-148758628.37328.40
15min12022858-202285838.58237.872.3938.6637.952.39
22026238-202623838.64738.72
32001264-200126438.17038.25
41997800-199780038.10438.18
51899392-189939236.22736.30
61966967-196696737.51637.59
20min12394728-239472845.67545.562.3945.8145.702.40
22470729-247072947.12447.27
32399410-239941045.76445.91
42401332-240133245.80145.94
52294227-229422743.75843.89
62371233-237123345.22745.36
30min13006431-300643157.34257.481.9557.5657.691.95
23096651-309665159.06359.28
33017207-301720757.54857.76
43032521-303252157.84058.06
52914339-291433955.58555.79
63014581-301458157.49757.71
45min13676325-367632570.11970.062.0870.4370.372.07
23802333-380233372.52272.84
33670085-367008570.00070.31
43633047-363304769.29369.61
53571161-357116168.11368.41
63687647-368764770.33570.64
60min14148478-414847879.12479.142.1079.5579.562.10
24301479-430147982.04382.48
34132750-413275078.82479.25
44155543-415554379.25979.69
54032784-403278476.91877.33
64123354-412335478.64579.07
90min14705660-470566089.75288.870.9690.3189.430.96
24689231-468923189.43890.01
34654754-465475488.78189.34
44673987-467398789.14789.71
54578104-457810487.31987.86
64654167-465416788.76989.33
120min14903429-490342993.52493.070.6794.2393.780.66
24857114-485711492.64093.37
34882199-488219993.11993.83
44922593-492259393.88994.60
54831954-483195492.16092.85
64881081-488108193.09793.80
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14957168-495716894.54994.070.6295.4194.940.61
24898480-489848093.42994.31
34939919-493991994.22095.08
44964840-496484094.69595.56
54892526-489252693.31694.16
64940457-494045794.23095.09
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