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%
114.272501922506532506612503542503492504420.09
214.332502182505452503820.10
单位质量响应值RSD%判断
17550.2517472.580.32数据可信
供试品溶液-1批-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%
5min144560-4456016.49616.734.4816.5016.744.49
241710-4171015.44115.44
344669-4466916.53616.54
446855-4685517.34517.35
547077-4707717.42717.43
646351-4635117.15917.16
10min176997-7699728.50329.885.6028.5329.905.60
276079-7607928.16428.19
376714-7671428.39928.43
484483-8448331.27531.30
585243-8524331.55631.59
684724-8472431.36431.39
15min1102968-10296838.11840.004.7538.1940.084.75
2103629-10362938.36238.44
3103592-10359238.34938.42
4113275-11327541.93342.01
5112367-11236741.59741.68
6112549-11254941.66441.75
20min1125195-12519546.34649.625.1346.4849.775.13
2128139-12813947.43647.57
3131040-13104048.51048.65
4141738-14173852.47052.62
5137692-13769250.97251.12
6140503-14050352.01352.16
30min1163879-16387960.66664.864.8360.8865.084.83
2170148-17014862.98763.20
3170691-17069163.18863.41
4182519-18251967.56767.81
5177634-17763465.75865.99
6186340-18634068.98169.22
45min1207091-20709176.66379.222.9276.9879.552.93
2210246-21024677.83178.15
3208607-20860777.22477.55
4218258-21825880.79781.15
5216945-21694580.31180.66
6222776-22277682.46982.82
60min1229972-22997285.13386.841.6285.5887.311.63
2235186-23518687.06387.51
3233875-23387586.57887.03
4235306-23530687.10887.59
5232080-23208085.91486.39
6241139-24113989.26789.76
90min1247124-24712491.48392.591.8992.0793.201.89
2250429-25042992.70693.30
3245309-24530990.81191.41
4257424-25742495.29695.93
5246636-24663691.30291.92
6253710-25371093.92194.56
120min1252744-25274493.56394.371.0094.3095.131.00
2256111-25611194.81095.56
3254584-25458494.24494.99
4259257-25925795.97496.76
5252247-25224793.37994.15
6254552-25455294.23395.03
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1257893-25789395.46995.420.5796.3696.340.58
2257992-25799295.50696.41
3255086-25508694.43095.34
4259443-25944396.04396.99
5257524-25752495.33396.26
6258564-25856495.71896.67
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100
标示量(mg)160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%
115.999562700956014495597819558541955699695596320.03
216.089599628960563496026310.05
单位质量响应值RSD%判断
597850.66597178.540.08数据可信
供试品溶液-1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%
5min13591510-359151033.50633.542.9233.5133.542.92
23406131-340613131.77731.78
33560239-356023933.21433.21
43689164-368916434.41734.42
53672693-367269334.26434.26
63651191-365119134.06334.06
10min14905157-490515745.76246.843.0445.8246.893.03
24855658-485565845.30045.35
34886624-488662445.58945.64
45147995-514799548.02748.08
55165864-516586448.19448.25
65162054-516205448.15848.21
15min15875219-587521954.81256.242.8554.9456.382.85
25857954-585795454.65054.78
35886547-588654754.91755.05
46194192-619419257.78757.92
56152137-615213757.39557.53
66206144-620614457.89958.04
20min16603953-660395361.61063.643.0961.8363.873.08
26646341-664634162.00662.23
36645571-664557161.99862.22
47002242-700224265.32665.56
57053899-705389965.80866.04
66980179-698017965.12065.35
30min17703591-770359171.86973.922.3072.2074.262.30
27826840-782684073.01973.34
37771126-777112672.49972.83
48135122-813512275.89576.24
57994451-799445174.58274.93
68111284-811128475.67276.01
45min18750213-875021381.63383.611.8782.0884.061.87
28890546-889054682.94283.39
38843334-884333482.50282.95
49162057-916205785.47585.94
58975358-897535883.73484.20
69148628-914862885.35085.82
60min19358919-935891987.31288.971.4187.8989.561.42
29487601-948760188.51289.10
39454778-945477888.20688.79
49718476-971847690.66691.28
59532324-953232488.93089.54
69665589-966558990.17390.78
90min19929107-992910792.63193.701.0493.3694.441.04
29997923-999792393.27394.00
39994575-999457593.24293.97
410221173-1022117395.35696.12
510013963-1001396393.42394.18
610104302-1010430294.26695.03
120min110131297-1013129794.51895.170.7795.4096.070.78
210181720-1018172094.98895.87
310176004-1017600494.93595.82
410354830-1035483096.60397.52
510166598-1016659894.84795.76
610196662-1019666295.12796.05
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110199371-1019937195.15395.680.7696.1996.730.77
210221563-1022156395.36096.40
310245819-1024581995.58696.63
410408956-1040895697.10898.19
510210169-1021016995.25396.32
610246686-1024668695.59496.67
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%
114.272493552494502510932501392503932500860.29
214.332498312502632500470.13
单位质量响应值RSD%判断
17525.3017449.200.31数据可信
供试品溶液-1批-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%
5min152672-5267219.52618.493.3019.5318.493.30
248754-4875418.07318.07
350048-5004818.55318.55
449982-4998218.52818.53
547797-4779717.71817.72
650027-5002718.54518.55
10min197620-9762036.18834.502.7536.2234.532.75
291566-9156633.94433.97
392988-9298834.47134.50
493697-9369734.73434.76
590126-9012633.41033.44
692355-9235534.23634.27
15min1127396-12739647.22646.682.4447.3246.762.44
2124836-12483646.27746.36
3129539-12953948.02048.11
4128393-12839347.59547.68
5121372-12137244.99345.08
6123935-12393545.94346.03
20min1160017-16001759.31857.103.3459.4957.263.34
2149670-14967055.48355.65
3159371-15937159.07959.25
4156305-15630557.94258.11
5148936-14893655.21155.37
6149877-14987755.56055.72
30min1196866-19686672.97871.652.2773.2571.912.27
2194600-19460072.13872.39
3198250-19825073.49173.76
4194034-19403471.92972.19
5187724-18772469.58969.84
6188235-18823569.77970.04
45min1229751-22975185.16984.412.1185.5684.792.11
2228681-22868184.77285.15
3235143-23514387.16887.56
4227234-22723484.23684.62
5224317-22431783.15583.52
6221146-22114681.97982.35
60min1247268-24726891.66390.551.4792.2091.071.47
2241255-24125589.43389.95
3249830-24983092.61293.15
4240671-24067189.21789.74
5243371-24337190.21890.72
6243132-24313290.12990.64
90min1253273-25327393.88994.070.8394.5894.740.83
2251357-25135793.17893.85
3252911-25291193.75494.44
4255017-25501794.53595.21
5252645-25264593.65694.31
6257312-25731295.38696.05
120min1260157-26015796.44095.361.0797.2896.191.07
2256492-25649295.08295.90
3260733-26073396.65497.50
4253570-25357093.99994.83
5256825-25682595.20596.02
6255698-25569894.78895.61
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1259962-25996296.36896.521.0197.3797.501.01
2260080-26008096.41297.39
3264751-26475198.14399.15
4257625-25762595.50296.49
5258036-25803695.65496.63
6261698-26169897.01297.99
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100
标示量(mg)160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%
115.999537679953864895503839547034954850695444500.07
216.089566071958019395731320.11
单位质量响应值RSD%判断
596901.19595344.030.19数据可信
供试品溶液-1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%
5min13938696-393869636.83135.472.1836.8335.472.17
23735368-373536834.93034.93
33768660-376866035.24135.24
43817962-381796235.70235.70
53702859-370285934.62634.63
63793668-379366835.47535.47
10min15526609-552660951.68050.721.4151.7450.781.41
25373068-537306850.24450.30
35432841-543284150.80350.86
45485179-548517951.29251.35
55315011-531501149.70149.76
65410284-541028450.59250.65
15min16592633-659263361.64861.161.7161.8061.301.71
26490546-649054660.69460.84
36696304-669630462.61862.76
46606490-660649061.77861.92
56389846-638984659.75259.89
66465254-646525460.45760.60
20min17408480-740848069.27768.791.7869.5369.041.78
27300260-730026068.26568.51
37552363-755236370.62370.87
47424740-742474069.42969.68
57194233-719423367.27467.51
67258018-725801867.87068.11
30min18523144-852314479.70179.131.6980.0779.491.68
28417569-841756978.71379.07
38679253-867925381.16081.53
48523229-852322979.70180.06
58297944-829794477.59577.95
68329356-832935677.88878.25
45min19425307-942530788.13787.931.4288.6488.421.42
29380694-938069487.72088.21
39623114-962311489.98690.49
49453483-945348388.40088.90
59269666-926966686.68187.16
69266271-926627186.65087.14
60min19887958-988795892.46392.351.0093.1193.001.00
29833432-983343291.95392.59
310053930-1005393094.01594.67
49897789-989778992.55593.20
59783837-978383791.48992.12
69800817-980081791.64892.28
90min110243713-1024371395.79095.800.6896.5996.600.69
210186381-1018638195.25496.04
310378934-1037893497.05497.86
410243295-1024329595.78696.58
510196852-1019685295.35196.13
610222744-1022274495.59496.38
120min110356764-1035676496.84796.710.8197.8197.660.82
210268933-1026893396.02696.97
310501812-1050181298.20399.17
410326343-1032634396.56297.52
510305669-1030566996.36997.31
610293251-1029325196.25397.20
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110370352-1037035296.97497.120.8398.0998.240.83
210297216-1029721696.29097.40
310551362-1055136298.66799.80
410363584-1036358496.91198.03
510356232-1035623296.84297.94
610379589-1037958997.06098.16
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%
114.272507222507722508122510752511062508970.08
214.332529022522062525540.20
单位质量响应值RSD%判断
17582.1317624.150.17数据可信
供试品溶液-2批-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%
5min136913-3691313.59414.6513.3013.5914.6513.31
246574-4657417.15117.15
338295-3829514.10214.10
432840-3284012.09412.09
545563-4556316.77916.78
638470-3847014.16714.17
10min187900-8790032.37034.185.1232.3934.205.12
292941-9294134.22634.25
389971-8997133.13333.16
489471-8947132.94932.97
5100418-10041836.98037.01
696167-9616735.41435.44
15min1128436-12843647.29848.106.4447.3748.186.44
2122838-12283845.23645.32
3126061-12606146.42346.50
4124995-12499546.03146.11
5144756-14475653.30853.40
6136621-13662150.31250.39
20min1156762-15676257.72959.655.5457.8859.815.54
2154753-15475356.98957.15
3155959-15595957.43357.59
4158415-15841558.33858.49
5176959-17695965.16765.35
6168985-16898562.23062.40
30min1195953-19595372.16273.406.0272.4173.666.02
2182935-18293567.36867.62
3192900-19290071.03771.29
4198273-19827373.01673.26
5216685-21668579.79680.08
6209088-20908876.99977.27
45min1229932-22993284.67584.943.4385.0585.333.44
2220571-22057181.22781.60
3224650-22465082.72983.10
4228985-22898584.32684.70
5240180-24018088.44988.87
6239663-23966388.25888.66
60min1239876-23987688.33790.192.8588.8590.722.85
2236644-23664487.14687.65
3241969-24196989.10789.62
4244843-24484390.16690.68
5254769-25476993.82194.39
6251421-25142192.58893.13
90min1254001-25400193.53893.701.0394.2094.371.05
2252571-25257193.01293.66
3251736-25173692.70493.36
4254094-25409493.57294.23
5254982-25498293.90094.62
6259214-25921495.45896.16
120min1249742-24974291.97094.341.5692.7995.171.57
2255204-25520493.98194.79
3254534-25453493.73594.55
4257865-25786594.96195.78
5261339-26133996.24197.12
6258316-25831695.12795.99
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1255716-25571694.17095.661.3795.1496.651.38
2258760-25876095.29196.25
3255835-25583594.21495.18
4263119-26311996.89697.87
5263780-26378097.13998.18
6261335-26133596.23997.26
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100
标示量(mg)160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%
115.999604036959922796087359615847961731196090310.08
216.089662413964249696524540.15
单位质量响应值RSD%判断
600940.03600276.990.08数据可信
供试品溶液-2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%
5min13094988-309498828.72530.727.2828.7330.727.28
23619971-361997133.59833.60
33313420-331342030.75330.75
43022669-302266928.05428.05
53557949-355794933.02233.02
63251267-325126730.17630.18
10min15240033-524003348.63450.453.2148.6850.503.21
25446789-544678950.55350.61
35390125-539012550.02750.08
45299794-529979449.18949.24
55732891-573289153.20853.26
65504209-550420951.08651.14
15min16521350-652135060.52662.103.2060.6562.243.20
26538757-653875760.68860.83
36603837-660383761.29261.43
46598799-659879961.24561.37
57074248-707424865.65865.80
66809961-680996163.20563.34
20min17425480-742548068.91770.423.4069.1570.663.40
27368068-736806868.38568.63
37422449-742244968.88969.13
47526859-752685969.85870.09
58038517-803851774.60774.86
67742017-774201771.85572.10
30min18609514-860951479.90780.933.3380.2581.283.33
28422579-842257978.17278.53
38523348-852334879.10779.46
48637012-863701280.16280.51
59203914-920391485.42485.80
68921684-892168482.80483.16
45min19484254-948425488.02588.902.4888.5089.392.48
29314862-931486286.45386.94
39415569-941556987.38887.87
49541933-954193388.56189.04
59952234-995223492.36992.89
69763276-976327690.61591.11
60min19880953-988095391.70792.581.9592.3393.221.96
29750616-975061690.49891.13
39839226-983922691.32091.95
49986159-998615992.68493.31
510279381-1027938195.40596.08
610111909-1011190993.85194.50
90min110199727-1019972794.66695.221.1695.4496.011.17
210115957-1011595793.88894.67
310181012-1018101294.49295.27
410263519-1026351995.25896.04
510421823-1042182396.72797.56
610375483-1037548396.29797.10
120min110188308-1018830894.56095.791.0695.5096.741.07
210244260-1024426095.07996.02
310273615-1027361595.35296.29
410399192-1039919296.51797.46
510487873-1048787397.34098.33
610330742-1033074295.88296.85
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110211537-1021153794.77596.201.1995.8797.311.20
210291328-1029132895.51696.61
310282123-1028212395.43196.53
410472318-1047231897.19698.30
510529312-1052931297.72598.88
610400462-1040046296.52997.66
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%
114.272503402502382507322508322510892506460.15
214.332555722551422553570.12
单位质量响应值RSD%判断
17564.5417819.751.03数据可信
供试品溶液-3批-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%
5min131051-3105111.37814.5211.9711.3814.5211.97
237441-3744113.71913.72
341073-4107315.05015.05
442125-4212515.43615.44
542019-4201915.39715.40
644104-4410416.16116.16
10min166883-6688324.50828.117.4824.5328.147.48
273352-7335226.87826.90
377247-7724728.30528.33
482261-8226130.14330.17
580603-8060329.53529.56
679942-7994229.29329.32
15min198364-9836436.04340.146.0936.1040.216.10
2109136-10913639.99040.06
3106033-10603338.85338.93
4114570-11457041.98142.06
5116694-11669442.76042.83
6112474-11247441.21341.29
20min1125018-12501845.81050.646.3845.9350.786.38
2138403-13840350.71450.85
3130831-13083147.94048.08
4143225-14322552.48152.63
5148830-14883054.53554.68
6142926-14292652.37252.52
30min1167989-16798961.55565.744.7661.7565.964.77
2181535-18153566.51966.74
3170737-17073762.56262.78
4182991-18299167.05367.29
5190975-19097569.97870.22
6182153-18215366.74566.98
45min1207558-20755876.05479.253.2476.3579.583.25
2216838-21683879.45579.78
3209346-20934676.71077.03
4217485-21748579.69280.04
5226607-22660783.03583.39
6219849-21984980.55880.90
60min1226908-22690883.14586.023.0683.5786.483.07
2228811-22881183.84284.30
3230018-23001884.28484.73
4240169-24016988.00488.48
5244652-24465289.64790.14
6237929-23792987.18387.66
90min1242921-24292189.01291.831.8889.5892.441.89
2251902-25190292.30392.91
3248863-24886391.19091.78
4255079-25507993.46794.09
5255590-25559093.65594.30
6249288-24928891.34591.97
120min1251337-25133792.09693.761.4092.8194.521.41
2257465-25746594.34295.10
3257432-25743294.33095.07
4256564-25656494.01294.79
5260553-26055395.47396.27
6251866-25186692.29093.06
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1254237-25423793.15995.111.3294.0296.031.33
2264274-26427496.83797.75
3258563-25856394.74495.64
4258116-25811694.58095.52
5261288-26128895.74396.70
6260932-26093295.61296.54
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100
标示量(mg)160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%
115.999593022961017796253559638034964743896228050.23
216.089808918981643498126760.06
单位质量响应值RSD%判断
601801.44610241.040.99数据可信
供试品溶液-3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%
5min12930285-293028526.95530.836.6426.9530.836.65
23292215-329221530.28430.28
33397992-339799231.25731.26
43496706-349670632.16532.17
53469150-346915031.91231.91
63522407-352240732.40232.40
10min14499111-449911141.38645.034.6341.4345.084.63
24797247-479724744.12944.18
34882203-488220344.91044.96
45110743-511074347.01347.07
55048620-504862046.44146.49
65034294-503429446.30946.36
15min15691596-569159652.35655.883.8652.4756.013.86
26014018-601401855.32255.45
35961960-596196054.84354.97
46289879-628987957.85957.99
56301387-630138757.96558.10
66190109-619010956.94157.07
20min16599007-659900760.70364.113.5760.9064.333.58
26949816-694981663.93064.15
36767483-676748362.25262.47
47175871-717587166.00966.24
57244734-724473466.64366.87
67081840-708184065.14465.37
30min17839544-783954472.11475.463.2372.4275.793.23
28234296-823429675.74576.07
37953134-795313473.15973.48
48365925-836592576.95677.29
58554961-855496178.69579.03
68274547-827454776.11676.45
45min18934831-893483182.18984.972.4382.6185.432.44
29281948-928194885.38285.83
39003896-900389682.82583.27
49360065-936006586.10186.57
59522665-952266587.59788.07
69322276-932227685.75386.21
60min19502364-950236487.41089.841.9687.9790.441.97
29822164-982216490.35290.94
39583000-958300088.15288.73
49889980-988998090.97691.59
510012605-1001260592.10492.72
69791767-979176790.07290.68
90min110000788-1000078891.99594.151.4992.7094.901.50
210330155-1033015595.02595.77
310117899-1011789993.07293.80
410354606-1035460695.25096.01
510388772-1038877295.56496.33
610220483-1022048394.01694.77
120min110212194-1021219493.94095.481.0594.8096.381.07
210416955-1041695595.82396.72
310331103-1033110395.03395.92
410455282-1045528296.17697.10
510521973-1052197396.78997.72
610340463-1034046395.11996.03
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110276133-1027613394.52895.941.0495.5497.001.06
210523867-1052386796.80797.87
310333102-1033310295.05296.09
410508559-1050855996.66697.75
510528935-1052893596.85397.94
610406351-1040635195.72696.80
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