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%
115.002490162493112491642491782493902492120.06
215.182481062508622494840.79
单位质量响应值RSD%判断
16614.1316435.050.77数据可信
长期24月-供试品溶液-2023112221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%
5min140327-4032715.82118.006.2715.8218.006.26
247822-4782218.76118.76
346061-4606118.07018.07
445718-4571817.93517.94
547754-4775418.73418.73
647649-4764918.69318.69
10min172512-7251228.44731.627.5228.4731.657.52
281670-8167032.04032.07
379433-7943331.16231.19
478654-7865430.85630.89
591163-9116335.76435.80
680215-8021531.46931.50
15min199163-9916338.90239.393.0838.9839.473.08
2106398-10639841.74141.83
3100412-10041239.39239.47
499196-9919638.91539.00
599687-9968739.10839.20
697543-9754338.26738.35
20min1108083-10808342.40245.184.2542.5445.324.24
2121461-12146147.65047.80
3118080-11808046.32446.47
4112821-11282144.26044.41
5112459-11245944.11844.27
6118050-11805046.31246.46
30min1134673-13467352.83354.923.9653.0455.143.96
2147910-14791058.02658.26
3141420-14142055.48055.70
4134165-13416552.63452.85
5137328-13732853.87554.10
6144406-14440656.65156.88
45min1156768-15676861.50163.202.2861.8063.522.29
2167202-16720265.59465.92
3161536-16153663.37263.69
4157850-15785061.92662.23
5161598-16159863.39663.72
6161691-16169163.43263.75
60min1166590-16659065.35467.402.9165.7567.822.91
2180156-18015670.67671.12
3174702-17470268.53768.96
4169520-16952066.50466.91
5168035-16803565.92166.35
6171835-17183567.41267.84
90min1186910-18691073.32674.812.1573.8375.342.15
2194861-19486176.44577.00
3195069-19506976.52777.06
4193228-19322875.80576.33
5186949-18694973.34173.88
6187160-18716073.42473.96
120min1196168-19616876.95877.931.8977.5978.591.88
2202680-20268079.51380.20
3200162-20016278.52579.19
4202617-20261779.48880.14
5193599-19359975.95076.61
6196622-19662277.13677.80
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1214146-21414684.01185.041.7884.7785.831.77
2217505-21750585.32986.15
3216796-21679685.05085.85
4217366-21736685.27486.05
5223148-22314887.54288.33
6211700-21170083.05183.84
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%
116.674910204490892049102734908959490957549095860.02
216.694922645492319949229220.01
单位质量响应值RSD%判断
294516.26294962.370.11数据可信
长期24月-供试品溶液-2023112221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%
5min11522900-152290028.80230.703.7828.8030.703.78
21684076-168407631.85131.85
31684175-168417531.85331.85
41591735-159173530.10430.10
51617720-161772030.59630.60
61638916-163891630.99731.00
10min12217263-221726341.93544.143.7841.9844.193.78
22395221-239522145.30145.35
32351560-235156044.47544.53
42259854-225985442.74042.79
52458001-245800146.48846.54
62320388-232038843.88543.94
15min12669650-266965050.49151.562.5250.6151.692.52
22834868-283486853.61653.74
32774886-277488652.48152.61
42669646-266964650.49150.61
52672837-267283750.55150.68
62735799-273579951.74251.87
20min12931560-293156055.44456.742.8055.6556.952.80
23130281-313028159.20359.42
33070316-307031658.06958.28
42936424-293642455.53655.74
52931978-293197855.45255.66
63001012-300101256.75856.97
30min13347873-334787363.31864.422.4163.6164.722.41
23529575-352957566.75567.07
33486246-348624665.93566.25
43338832-333883263.14763.45
53345103-334510363.26663.57
63388014-338801464.07764.38
45min13741044-374104470.75471.281.7371.1571.691.73
23860898-386089873.02173.45
33842254-384225472.66873.09
43719050-371905070.33870.74
53727877-372787770.50570.92
63721000-372100070.37570.79
60min13965789-396578975.00575.201.8275.5275.741.82
24061375-406137576.81277.36
34066194-406619476.90477.45
43947995-394799574.66875.19
53893172-389317273.63174.16
63923232-392323274.20074.73
90min14230788-423078880.01780.351.5380.6681.011.53
24291649-429164981.16881.85
34341171-434117182.10482.77
44269519-426951980.74981.39
54186962-418696279.18879.84
64170475-417047578.87679.53
120min14392169-439216983.06983.171.4883.8483.961.47
24442395-444239584.01984.83
34484591-448459184.81785.62
44414543-441454383.49284.27
54306076-430607681.44082.22
64345761-434576182.19182.98
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14647215-464721587.89288.781.1988.8189.711.18
24651055-465105587.96588.92
34753188-475318889.89790.85
44687357-468735788.65289.57
54773060-477306090.27291.19
64654056-465405688.02288.94
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%
115.002371192371232373822372082371152371890.05
215.182374962375722375340.03
单位质量响应值RSD%判断
15812.6015647.830.75数据可信
长期24月-供试品溶液-2023112221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%
5min141530-4153017.11518.578.6917.1218.578.69
245910-4591018.92018.92
340236-4023616.58216.58
443882-4388218.08518.08
548843-4884320.12920.13
650011-5001120.61020.61
10min173416-7341630.25633.367.0730.2833.397.07
284622-8462234.87434.91
375740-7574031.21431.24
488906-8890636.64036.67
580465-8046533.16133.19
682554-8255434.02234.06
15min193669-9366938.60340.775.7838.6840.855.77
2109562-10956245.15245.24
395495-9549539.35539.43
4100548-10054841.43841.53
596280-9628039.67939.77
697960-9796040.37140.46
20min1111047-11104745.76446.973.3345.9147.133.33
2120958-12095849.84950.01
3112506-11250646.36646.51
4114488-11448847.18247.34
5110504-11050445.54145.70
6114353-11435347.12747.29
30min1131134-13113454.04354.614.1054.2654.844.09
2128871-12887153.11053.36
3127843-12784352.68652.91
4136126-13612656.10056.34
5129245-12924553.26453.49
6141823-14182358.44858.68
45min1155192-15519263.95764.683.2564.2765.013.24
2162950-16295067.15467.49
3152054-15205462.66462.97
4163396-16339667.33867.67
5152035-15203562.65662.98
6156087-15608764.32664.66
60min1166278-16627868.52669.313.3868.9469.743.38
2177257-17725773.05173.50
3160498-16049866.14466.56
4171496-17149670.67671.12
5167664-16766469.09769.52
6165898-16589868.36968.81
90min1183367-18336775.56976.392.5076.1076.942.51
2192482-19248279.32579.90
3178985-17898573.76374.29
4185607-18560776.49277.05
5183500-18350075.62376.16
6188245-18824577.57978.13
120min1191026-19102678.72580.523.3379.3881.203.32
2204719-20471984.36885.07
3186617-18661776.90877.56
4199965-19996582.40983.10
5196741-19674181.08081.75
6193226-19322679.63280.32
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1215458-21545888.79488.672.0389.5889.482.03
2217358-21735889.57790.42
3207119-20711985.35786.13
4219951-21995190.64691.47
5216579-21657989.25690.06
6214500-21450088.39989.22
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%
116.674695514469290546926954692186468785046922300.06
216.694674525467252646735260.04
单位质量响应值RSD%判断
281477.50280019.530.37数据可信
长期24月-供试品溶液-2023112221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%
5min11534777-153477730.47432.383.5230.4732.383.53
21693990-169399033.63533.64
31658155-165815532.92432.92
41601865-160186531.80631.81
51625292-162529232.27132.27
61671271-167127133.18433.18
10min12193226-219322643.54846.023.6543.6046.073.64
22403777-240377747.72847.78
32328580-232858046.23546.29
42402404-240240447.70147.75
52244867-224486744.57344.63
62332397-233239746.31146.37
15min12599286-259928651.61053.532.8151.7353.662.82
22804338-280433855.68255.82
32729434-272943454.19454.33
42718422-271842253.97654.11
52619426-261942652.01052.14
62703668-270366853.68353.82
20min12884410-288441057.27258.892.4257.4859.112.42
23064030-306403060.83861.07
33014055-301405559.84660.07
42987997-298799759.32859.55
52885011-288501157.28357.50
62959839-295983958.76958.99
30min13274378-327437865.01567.565.6165.3267.885.60
23780261-378026175.05975.39
33345575-334557566.42866.75
43376720-337672067.04767.37
53268098-326809864.89065.20
63371004-337100466.93367.25
45min13692201-369220173.31173.761.7173.7274.191.72
23781539-378153975.08475.54
33733854-373385474.13874.57
43782545-378254575.10475.54
53619576-361957671.86972.29
63680238-368023873.07373.50
60min13899339-389933977.42377.851.3077.9678.411.31
24009416-400941679.60980.19
33923337-392333777.90078.46
43941130-394113078.25378.81
53866738-386673876.77677.31
63886170-388617077.16277.72
90min14206318-420631883.51983.300.8684.1883.980.87
24244440-424444084.27684.99
34216937-421693783.73084.42
44196915-419691583.33284.02
54156513-415651382.53083.20
64150776-415077682.41683.10
120min14389064-438906487.14786.720.9887.9587.540.99
24411057-441105787.58488.44
34395523-439552387.27588.10
44380181-438018186.97187.80
54323930-432393085.85486.66
64304788-430478885.47486.29
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14727371-472737193.86493.060.7194.8194.030.69
24641612-464161292.16293.16
34714986-471498693.61994.59
44699159-469915993.30494.28
54678710-467871092.89893.85
64660447-466044792.53693.50
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%
115.002404522405422406162405972408262406070.06
215.182432262432922432590.02
单位质量响应值RSD%判断
16040.4716024.970.07数据可信
长期24月-供试品溶液-2023112421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%
5min146874-4687418.95316.039.1618.9516.039.14
238636-3863615.62215.62
339107-3910715.81215.81
436844-3684414.89714.90
537977-3797715.35515.36
638388-3838815.52115.52
10min187050-8705035.19731.476.2735.2331.496.27
276424-7642430.90130.93
374823-7482330.25330.28
478265-7826531.64531.67
573122-7312229.56529.59
677257-7725731.23731.26
15min1108734-10873443.96440.035.3144.0540.105.31
296909-9690939.18339.26
395271-9527138.52138.60
4101341-10134140.97541.05
595933-9593338.78938.86
695802-9580238.73638.81
20min1119821-11982148.44745.704.3148.6145.854.31
2110426-11042644.64944.79
3111299-11129945.00245.14
4118340-11834047.84847.99
5107676-10767643.53743.68
6110643-11064344.73644.88
30min1144253-14425358.32654.164.8158.5754.384.81
2132188-13218853.44853.66
3129495-12949552.35952.57
4139478-13947856.39556.62
5128257-12825751.85852.07
6130095-13009552.60152.82
45min1162095-16209565.54062.253.9165.8862.563.91
2150885-15088561.00761.31
3150011-15001160.65460.96
4161276-16127665.20965.53
5149582-14958260.48160.78
6149868-14986860.59660.90
60min1179251-17925172.47768.034.1372.9368.444.13
2163402-16340266.06866.48
3166367-16636767.26767.67
4174378-17437870.50670.93
5162453-16245365.68566.08
6163645-16364566.16766.57
90min1196000-19600079.24975.203.6279.8275.733.62
2181816-18181673.51474.03
3180307-18030772.90473.42
4192986-19298678.03078.58
5181637-18163773.44173.95
6183178-18317874.06474.58
120min1207663-20766383.96479.163.6484.6779.823.64
2186613-18661375.45376.09
3194928-19492878.81579.45
4199292-19929280.58081.26
5193471-19347178.22678.86
6192709-19270977.91878.56
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1220400-22040089.11486.023.0389.9686.813.03
2202094-20209481.71382.48
3211949-21194985.69786.47
4218288-21828888.26089.07
5210840-21084085.24986.01
6212972-21297286.11186.88
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%
116.674726841472352247212314724971472316147239450.05
216.694778793477971247792520.02
单位质量响应值RSD%判断
283380.02286354.220.74数据可信
长期24月-供试品溶液-2023112421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%
5min11738689-173868934.02430.825.1934.0230.825.18
21551362-155136230.35830.36
31534016-153401630.01930.02
41560218-156021830.53230.53
51545045-154504530.23530.23
61519114-151911429.72729.73
10min12449615-244961547.93644.394.5847.9944.444.58
22219474-221947443.43343.48
32198080-219808043.01443.06
42337442-233744245.74145.79
52215477-221547743.35443.40
62190813-219081342.87242.92
15min12844248-284424855.65952.224.3255.8052.344.32
22609165-260916551.05851.18
32597027-259702750.82150.94
42783571-278357154.47154.60
52603510-260351050.94851.07
62572350-257235050.33850.46
20min13112833-311283360.91557.714.0361.1457.924.02
22885138-288513856.45956.67
32871524-287152456.19256.40
43088194-308819460.43260.65
52889821-288982156.55156.76
62846596-284659655.70555.91
30min13486740-348674068.23265.063.8368.5665.373.83
23261617-326161763.82664.13
33239048-323904863.38563.68
43487531-348753168.24768.57
53264145-326414563.87664.18
63209864-320986462.81363.11
45min13824472-382447274.84171.983.3875.2972.403.39
23605617-360561770.55870.97
33591335-359133570.27870.68
43847793-384779375.29775.73
53629865-362986571.03271.44
63569625-356962569.85470.26
60min14065593-406559379.55976.593.1280.1377.133.12
23837280-383728075.09175.62
33836239-383623975.07175.59
44075127-407512779.74680.30
53854539-385453975.42975.96
63814266-381426674.64175.16
90min14329192-432919284.71782.072.6585.4282.742.66
24098099-409809980.19580.85
34119637-411963780.61781.26
44341695-434169584.96285.65
54150197-415019781.21581.87
64125278-412527880.72781.37
120min14492144-449214487.90685.412.3488.7586.212.35
24257503-425750383.31584.10
34310531-431053184.35285.13
44492396-449239687.91188.74
54327640-432764084.68785.47
64306267-430626784.26985.05
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14733426-473342692.62890.751.5893.6291.701.60
24552171-455217189.08190.00
34597399-459739989.96690.89
44717364-471736492.31393.29
54634530-463453090.69391.62
64590892-459089289.83990.76
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