左氨氯地平缬沙坦片项目信息
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%
114.001193041193951190781190601189091191490.17
214.161215231216351215790.07
单位质量响应值RSD%判断
8510.648586.090.63数据可信
供试品溶液-2024081921批-左氨氯地平-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%
5min113083-130839.6639.986.409.669.986.40
212282-122829.0729.07
314704-1470410.86110.86
413635-1363510.07110.07
513168-131689.7269.73
614208-1420810.49410.49
10min130955-3095522.86423.393.3322.8823.413.33
229948-2994822.12022.14
331772-3177223.46723.49
432345-3234523.89023.91
532100-3210023.70923.73
632861-3286124.27224.29
15min145877-4587733.88533.744.8933.9433.794.89
242717-4271731.55131.60
343850-4385032.38832.45
445258-4525833.42833.48
547983-4798335.44135.50
648371-4837135.72735.79
20min158129-5812942.93543.413.5643.0543.523.56
255897-5589741.28641.39
358634-5863443.30843.42
457665-5766542.59242.70
561641-6164145.52945.64
660684-6068444.82244.94
30min177242-7724257.05257.242.5757.2357.422.57
274355-7435554.91955.09
377206-7720657.02557.21
476872-7687256.77956.96
579347-7934758.60758.80
679919-7991959.02959.22
45min196329-9632971.15071.812.2971.4372.092.30
293422-9342269.00369.27
397955-9795572.35172.63
497053-9705371.68471.96
599740-9974073.66973.96
698834-9883473.00073.29
60min1110423-11042381.56081.462.2781.9681.862.27
2106999-10699979.03179.41
3112589-11258983.16083.56
4108318-10831880.00580.40
5113592-11359283.90084.31
6109772-10977281.07981.49
90min1123702-12370291.36891.241.7091.9091.781.70
2120558-12055889.04689.56
3122513-12251390.48991.03
4123386-12338691.13491.67
5126936-12693693.75694.31
6124073-12407391.64292.19
120min1130234-13023496.19295.382.0296.8896.072.01
2125746-12574692.87793.54
3130918-13091896.69897.39
4129320-12932095.51796.20
5132266-13226697.69398.40
6126305-12630593.29093.99
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1130137-13013796.12196.301.2096.9797.151.20
2130067-13006796.06996.88
3130596-13059696.46097.31
4127871-12787194.44795.29
5132715-13271598.02598.89
6130910-13091096.69297.55
左氨氯地平缬沙坦片项目信息
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%
115.884546864454820845454844547857454392345464670.04
215.964580277458296545816210.05
单位质量响应值RSD%判断
286301.45287068.980.19数据可信
供试品溶液-2024081921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%
5min1617308-61730812.00312.364.1112.0012.364.10
2610218-61021811.86511.87
3661556-66155612.86312.86
4653711-65371112.71112.71
5609123-60912311.84411.84
6662522-66252212.88212.88
10min11473219-147321928.64629.362.9428.6729.382.94
21451644-145164428.22628.25
31576053-157605330.64530.67
41512307-151230729.40629.43
51510516-151051629.37129.39
61536880-153688029.88429.90
15min12126816-212681641.35441.682.2441.4241.752.23
22082852-208285240.50040.57
32122923-212292341.27941.35
42126585-212658541.35041.42
52198560-219856042.74942.82
62204848-220484842.87242.94
20min12621255-262125550.96851.282.5451.1151.422.54
22554339-255433949.66749.80
32603498-260349850.62350.76
42607588-260758850.70350.84
52723111-272311152.94953.09
62713916-271391652.77052.91
30min13331155-333115564.77264.792.2964.9965.012.29
23217955-321795562.57162.79
33297848-329784864.12464.35
43311266-331126664.38564.61
53423205-342320566.56266.79
63410220-341022066.30966.54
45min14034811-403481178.45477.862.0678.7878.192.06
23863386-386338675.12175.44
33987829-398782977.54077.87
43977670-397767077.34377.67
54097308-409730879.66980.01
64064064-406406479.02379.36
60min14422129-442212985.98585.771.7086.4586.231.70
24281520-428152083.25183.70
34414582-441458285.83886.30
44389855-438985585.35885.82
54505325-450532587.60388.07
64453312-445331286.59187.06
90min14845182-484518294.21193.851.3294.8194.451.32
24715210-471521091.68492.27
34836147-483614794.03594.64
44816959-481695993.66294.26
54910724-491072495.48596.10
64835621-483562194.02594.64
120min15018860-501886097.58897.281.0998.3598.051.09
24917077-491707795.60996.35
35025867-502586797.72498.49
44990117-499011797.02997.79
55080634-508063498.78999.57
64986467-498646796.95897.73
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15074474-507447498.66998.500.9199.5999.420.91
24997418-499741897.17198.07
35090523-509052398.98299.91
45055173-505517398.29499.21
55132667-513266799.801100.74
65043877-504387798.07599.01
左氨氯地平缬沙坦片项目信息
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%
114.001184041184481185001180781180051182870.20
214.161211781210961211370.05
单位质量响应值RSD%判断
8449.078554.870.88数据可信
供试品溶液-2024081921批-左氨氯地平-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%
5min115163-1516311.26110.437.7311.2610.427.73
213442-134429.9839.98
313082-130829.7159.72
413977-1397710.38010.38
515551-1555111.54911.55
613011-130119.6639.66
10min140601-4060130.15324.9710.9930.1724.9910.98
231639-3163923.49723.51
331190-3119023.16323.18
432879-3287924.41824.44
534631-3463125.71925.74
630790-3079022.86622.88
15min160434-6043444.88236.8311.1544.9536.8911.14
244683-4468333.18433.24
348115-4811535.73335.79
449357-4935736.65536.71
547558-4755835.31935.38
647431-4743135.22535.28
20min168943-6894351.20146.297.2051.3446.417.20
255631-5563141.31541.43
360723-6072345.09645.21
464162-6416247.65047.77
563993-6399347.52547.65
660506-6050644.93545.05
30min199041-9904173.55361.6910.0273.7861.8910.01
276305-7630556.66856.85
378663-7866358.42058.61
478553-7855358.33858.54
584560-8456062.79963.00
681307-8130760.38360.57
45min1119551-11955188.78576.638.2489.1476.948.24
296223-9622371.46171.74
397735-9773572.58372.87
4103700-10370077.01377.31
5102480-10248076.10776.41
699449-9944973.85674.14
60min1126315-12631593.80986.024.9594.3186.454.97
2109505-10950581.32581.72
3113578-11357884.34984.76
4116868-11686886.79387.22
5115686-11568685.91586.35
6113042-11304283.95184.36
90min1135877-135877100.91094.723.72101.5795.303.75
2121402-12140290.16090.69
3126202-12620293.72594.27
4128744-12874495.61396.18
5126607-12660794.02594.60
6126455-12645593.91394.46
120min1137091-137091101.81197.512.43102.6498.242.46
2127492-12749294.68395.36
3131222-13122297.45398.16
4131555-13155597.70098.43
5129933-12993396.49697.23
6130538-13053896.94597.65
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1134485-13448599.87698.271.09100.8799.161.13
2130241-13024196.72497.56
3132345-13234598.28799.15
4133118-13311898.86199.75
5132199-13219998.17899.07
6131552-13155297.69898.57
左氨氯地平缬沙坦片项目信息
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%
115.884534674453540145430154540540453685945380980.08
215.964588575458690645877400.03
单位质量响应值RSD%判断
285774.43287452.380.42数据可信
供试品溶液-2024081921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%
5min11080748-108074821.02013.7526.3021.0213.7526.31
2621274-62127412.08312.08
3612230-61223011.90711.91
4634634-63463412.34312.34
5691864-69186413.45613.46
6600670-60067011.68311.68
10min12249253-224925343.74631.6618.9143.7831.6818.91
21467632-146763228.54428.56
31483159-148315928.84628.87
41530736-153073629.77229.79
51577189-157718930.67530.70
61458466-145846628.36628.39
15min12966375-296637557.69445.0614.0757.8045.1314.09
22082963-208296340.51240.58
32179173-217917342.38342.45
42250566-225056643.77243.84
52275004-227500444.24744.32
62145292-214529241.72441.79
20min13538260-353826068.81755.4512.1969.0255.6012.20
22569463-256946349.97450.11
32687621-268762152.27252.41
42803976-280397654.53554.68
52792174-279217454.30654.45
62713272-271327252.77152.91
30min14282708-428270883.29669.6510.0183.6169.9010.03
23278345-327834563.76163.98
33410993-341099366.34166.57
43572846-357284669.48969.72
53523324-352332468.52668.76
63419560-341956066.50866.73
45min14798639-479863993.33082.047.1093.7982.407.13
23951893-395189376.86177.19
34090152-409015279.55079.89
44227222-422722282.21682.57
54167528-416752881.05581.41
64073709-407370979.23179.57
60min15045800-504580098.13789.435.0098.7589.925.04
24407299-440729985.71986.17
34502980-450298087.58088.05
44610618-461061889.67390.16
54548966-454896688.47488.96
64472492-447249286.98787.45
90min15206839-5206839101.26996.002.94102.0596.652.99
24804284-480428493.44094.04
34887988-488798895.06895.68
44978412-497841296.82797.46
54895291-489529195.21095.84
64843264-484326494.19894.81
120min15252911-5252911102.16598.691.99103.1199.502.03
24999495-499949597.23797.99
35065112-506511298.51399.29
45122361-512236199.626100.42
55018345-501834597.60398.40
64987748-498774897.00897.78
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15246669-5246669102.04499.441.62103.16100.421.67
25062007-506200798.45299.37
35114750-511475099.478100.42
45170368-5170368100.560101.52
55057189-505718998.35999.31
65027172-502717297.77598.71
左氨氯地平缬沙坦片项目信息
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%
114.001182751183171182841183621184361183350.06
214.161196501195091195800.09
单位质量响应值RSD%判断
8452.508444.920.07数据可信
供试品溶液-2024082021批-左氨氯地平-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%
5min121627-2162716.16217.2312.7616.1617.2312.76
220461-2046115.29115.29
321185-2118515.83215.83
425303-2530318.90918.91
527984-2798420.91320.91
621781-2178116.27716.28
10min137512-3751228.03327.438.3228.0627.468.32
232445-3244524.24624.27
335424-3542426.47326.50
439484-3948429.50729.54
540552-4055230.30530.34
634814-3481426.01726.04
15min151791-5179138.70438.286.5238.7838.356.53
246058-4605834.42034.49
349340-4934036.87236.94
453329-5332939.85339.93
555774-5577441.68041.77
651017-5101738.12538.20
20min161095-6109545.65746.355.9045.8046.485.90
256368-5636842.12442.25
361252-6125245.77445.91
463901-6390147.75447.90
567479-6747950.42850.58
662001-6200146.33446.47
30min180981-8098160.51860.163.0660.7360.373.07
277082-7708257.60457.80
378514-7851458.67458.88
483627-8362762.49562.72
582623-8262361.74561.98
680183-8018359.92260.13
45min1101596-10159675.92474.336.0676.2474.646.06
288825-8882566.38066.67
399875-9987574.63874.94
4103457-10345777.31477.65
5105922-10592279.15779.50
697067-9706772.53972.85
60min1113671-11367184.94784.372.3185.3984.812.33
2109186-10918681.59682.00
3111619-11161983.41483.84
4115589-11558986.38186.84
5115852-11585286.57787.05
6111477-11147783.30883.74
90min1123867-12386792.56792.721.6693.1593.291.68
2121055-12105590.46691.00
3123287-12328792.13492.70
4125137-12513793.51694.12
5127249-12724995.09495.71
6123795-12379592.51393.08
120min1124063-12406392.71395.341.8593.4596.071.85
2127110-12711094.99095.68
3127054-12705494.94995.67
4131219-13121998.06198.82
5128804-12880496.25697.03
6127187-12718795.04895.77
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1129695-12969596.92297.321.2097.8198.221.22
2129091-12909196.47197.32
3128226-12822695.82496.71
4132230-13223098.81799.74
5131836-13183698.52299.46
6130314-13031497.38598.27
左氨氯地平缬沙坦片项目信息
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%
115.884537340453978845433454546678454696945428240.10
215.964562734456577345642540.05
单位质量响应值RSD%判断
286072.04285980.830.03数据可信
供试品溶液-2024082021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%
5min1997785-99778519.44621.0310.7819.4521.0310.77
2952282-95228218.55918.56
31032278-103227820.11820.12
41205704-120570423.49823.50
51239398-123939824.15524.15
61047575-104757520.41620.42
10min11740344-174034433.91834.477.4733.9534.507.47
21605166-160516631.28331.31
31695496-169549633.04433.08
41880766-188076636.65436.69
51967883-196788338.35238.39
61722582-172258233.57133.61
15min12335045-233504545.50845.595.2745.6045.685.28
22156516-215651642.02842.11
32280374-228037444.44244.53
42443419-244341947.62047.72
52505484-250548448.82948.93
62314848-231484845.11445.20
20min12787132-278713254.31854.634.3754.4854.794.38
22616813-261681350.99951.15
32768792-276879253.96154.12
42892994-289299456.38256.56
52975603-297560357.99258.18
62776230-277623054.10654.27
30min13459978-345997867.43267.463.5367.6967.723.54
23280259-328025963.92964.17
33426340-342634066.77667.03
43539241-353924168.97669.25
53642663-364266370.99271.27
63420864-342086466.66966.92
45min14089005-408900579.69179.313.2580.0679.683.26
23862077-386207775.26875.61
34021220-402122078.37078.73
44156218-415621881.00181.39
54250585-425058582.84083.24
64036742-403674278.67279.04
60min14477412-447741287.26087.082.2787.7687.582.28
24335863-433586384.50284.97
34411191-441119185.97086.46
44548615-454861588.64889.17
54615201-461520189.94690.48
64421479-442147986.17086.67
90min14829885-482988594.13094.181.5294.7894.831.54
24746671-474667192.50893.12
34775792-477579293.07693.71
44895508-489550895.40996.08
54940535-494053596.28696.97
64806327-480632793.67194.31
120min14910634-491063495.70396.851.1596.5197.661.17
24918097-491809795.84996.61
34929548-492954896.07296.86
45029767-502976798.02598.86
55035511-503551198.13798.99
64992849-499284997.30698.10
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14957871-495787196.62497.680.9997.5998.651.01
24980172-498017297.05997.98
34975344-497534496.96597.92
45062597-506259798.66599.66
55077989-507798998.96599.98
65019721-501972197.82998.79
左氨氯地平缬沙坦片项目信息
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%
114.001199421199111198451196781196261198000.12
214.161203181206341204760.19
单位质量响应值RSD%判断
8557.148508.190.41数据可信
供试品溶液-2024082021批-左氨氯地平-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%
5min127649-2764920.45918.3611.4920.4618.3611.49
221962-2196216.25116.25
321403-2140315.83715.84
426946-2694619.93919.94
527380-2738020.26020.26
623519-2351917.40317.40
10min140460-4046029.93928.777.5529.9728.807.54
234028-3402825.17925.21
337282-3728227.58727.61
442118-4211831.16631.20
540824-4082430.20830.24
638546-3854628.52328.55
15min153482-5348239.57539.145.4139.6639.215.41
247539-4753935.17735.25
352245-5224538.65938.73
455672-5567241.19541.28
553811-5381139.81839.90
654578-5457840.38640.46
20min164414-6441447.66448.476.7447.8148.626.74
257579-5757942.60642.73
365198-6519848.24448.38
470222-7022251.96252.12
567400-6740049.87350.02
668224-6822450.48350.63
30min182635-8263561.14762.004.9861.3862.234.98
277017-7701756.99057.19
382931-8293161.36661.58
489022-8902265.87366.11
583945-8394562.11662.35
687203-8720364.52764.75
45min1100390-10039074.28575.823.9174.6276.153.92
296457-9645771.37571.67
3104298-10429877.17777.50
4105465-10546578.04078.39
5100782-10078274.57574.91
6107431-10743179.49579.83
60min1115221-11522185.25984.722.4985.7185.182.50
2109683-10968381.16181.57
3114283-11428384.56585.01
4118106-11810687.39487.87
5113552-11355284.02484.49
6116145-11614585.94386.41
90min1127994-12799494.71192.792.4595.3193.392.46
2119683-11968388.56189.11
3125262-12526292.68993.28
4128127-12812794.80995.44
5125419-12541992.80593.41
6125910-12591093.16993.78
120min1129901-12990196.12294.311.5296.8895.061.53
2125232-12523292.66793.36
3126493-12649393.60094.34
4129361-12936195.72296.51
5128013-12801394.72595.48
6125740-12574093.04393.81
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1132609-13260998.12694.872.7399.0495.772.72
2123052-12305291.05491.90
3129074-12907495.51096.41
4129892-12989296.11597.06
5129507-12950795.83096.74
6125091-12509192.56393.48
左氨氯地平缬沙坦片项目信息
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%
115.884614395461571646171734616705461347746154930.04
215.964604644460245146035480.04
单位质量响应值RSD%判断
290648.17288442.860.54数据可信
供试品溶液-2024082021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%
5min11231113-123111323.70221.709.6623.7021.709.66
21010184-101018419.44919.45
31000886-100088619.26919.27
41212910-121291023.35123.35
51224586-122458623.57623.58
61083217-108321720.85520.85
10min11914254-191425436.85435.296.3536.8935.326.35
21644638-164463831.66331.70
31742160-174216033.54133.57
41935522-193552237.26437.30
51914662-191466236.86236.90
61846366-184636635.54735.58
15min12473609-247360947.62346.785.4347.7246.875.43
22192957-219295742.22042.30
32364064-236406445.51445.60
42554277-255427749.17649.28
52491925-249192547.97648.08
62500993-250099348.15048.24
20min12910568-291056856.03655.795.0656.2255.965.06
22624535-262453550.52950.68
32870864-287086455.27155.43
43045053-304505358.62558.81
52963611-296361157.05757.24
62972185-297218557.22257.40
30min13562296-356229668.58368.854.0268.8669.114.02
23303405-330340563.59963.84
33591219-359121969.14069.40
43710322-371032271.43371.71
53623337-362333769.75870.03
63665380-366538070.56770.84
45min14156054-415605480.01480.543.0880.4080.923.09
23952777-395277776.10176.45
34177593-417759380.42980.80
44328038-432803883.32583.73
54220592-422059281.25781.65
64265121-426512182.11482.50
60min14573840-457384088.05887.482.2188.5888.002.22
24353440-435344083.81484.29
34527885-452788587.17387.68
44638807-463880789.30889.85
54575219-457521988.08488.61
64594935-459493588.46488.99
90min14963704-496370495.56393.931.6596.2394.591.66
24738358-473835891.22591.84
34858384-485838493.53694.19
44936507-493650795.04095.73
54913926-491392694.60595.28
64861676-486167693.59994.27
120min15074676-507467697.70095.711.5598.5396.521.55
24875368-487536893.86394.63
34962829-496282995.54796.35
45012801-501280196.50997.35
55008536-500853696.42797.26
64892118-489211894.18595.01
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15157337-515733799.29196.301.84100.2897.281.84
24896811-489681194.27695.20
34985350-498535095.98096.95
45006217-500621796.38297.39
55036761-503676196.97097.96
64928547-492854794.88795.87
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-08-28 14:45:18 完成)
生成报告数据部分下载报告(谢超君 于 2024-08-28 14:46:01 完成)
Current page cost:84 ms