阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972862012862092862712864102860292862240.05
211.002856082857162856620.03
单位质量响应值RSD%判断
26091.5225969.270.34数据可信
供试品溶液-20220127批-阿齐沙坦-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%
5min176289-7628926.29822.2129.8626.3022.2129.86
274936-7493625.83225.83
330027-3002710.35110.35
473989-7398925.50525.51
578353-7835327.00927.01
653022-5302218.27718.28
10min1267111-26711192.07789.795.7692.2289.915.79
2271363-27136393.54393.69
3235898-23589881.31781.37
4266608-26660891.90492.05
5273524-27352494.28894.44
6248286-24828685.58885.69
15min1300591-300591103.618106.041.71104.28106.661.68
2309987-309987106.857107.52
3314528-314528108.422108.93
4309810-309810106.796107.45
5308548-308548106.361107.03
6302200-302200104.173104.75
20min1303485-303485104.616106.851.83105.85108.061.80
2312947-312947107.877109.13
3317106-317106109.311110.42
4313993-313993108.238109.48
5308770-308770106.437107.70
6303534-303534104.633105.79
30min1303382-303382104.580106.721.66106.39108.521.63
2313219-313219107.971109.83
3316089-316089108.960110.68
4312888-312888107.857109.70
5306730-306730105.734107.59
6305243-305243105.222106.96
45min1301721-301721104.008105.881.32106.40108.271.29
2309949-309949106.844109.30
3311528-311528107.388109.71
4310231-310231106.941109.39
5303259-303259104.538106.98
6306162-306162105.538107.86
60min1299392-299392103.205105.611.85106.18108.601.81
2306567-306567105.678108.73
3313297-313297107.998110.92
4312755-312755107.811110.85
5304027-304027104.802107.83
6302237-302237104.185107.09
极限1298654-298654102.950105.481.59106.50109.051.53
2306505-306505105.657109.29
3313649-313649108.119111.64
4307401-307401105.966109.60
5304998-304998105.137108.74
6304771-304771105.059108.55
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937151871579718847200371882717730.30
214.987207971831719550.25
单位质量响应值RSD%判断
4807.304803.400.06数据可信
供试品溶液-20220127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%
5min144561-4456160.12259.251.8460.1259.251.84
243750-4375059.02859.03
344277-4427759.73959.74
444737-4473760.35960.36
542526-4252657.37657.38
643645-4364558.88658.89
10min160756-6075681.97284.612.5582.3184.942.54
264593-6459387.14987.48
363278-6327885.37585.71
464283-6428386.73187.07
562162-6216283.86984.19
661203-6120382.57582.90
15min165166-6516687.92290.492.2588.7191.282.25
268678-6867892.66193.47
367993-6799391.73792.54
468515-6851592.44193.26
565963-6596388.99889.78
666080-6608089.15689.94
20min166862-6686290.21192.242.1591.4993.542.14
269975-6997594.41195.74
368676-6867692.65893.97
470150-7015094.64795.98
567547-6754791.13592.41
666987-6698790.37991.66
30min167860-6786091.55793.892.4393.3495.712.42
271564-7156496.55598.41
368766-6876692.78094.61
471873-7187396.97198.83
568885-6888592.94094.73
668586-6858692.53794.32
45min167672-6767291.30393.872.1193.5996.202.11
271228-7122896.10198.49
369150-6915093.29895.64
471439-7143996.38698.78
569082-6908293.20695.51
668863-6886392.91095.21
60min167752-6775291.41193.862.3794.2196.722.36
271044-7104495.85398.77
369119-6911993.25696.12
472070-7207097.237100.17
568987-6898793.07895.90
668433-6843392.33095.14
极限167385-6738590.91694.172.1494.2297.552.13
271328-7132896.23699.69
370285-7028594.82998.21
471251-7125196.13299.60
569123-6912393.26196.60
669421-6942193.66396.99
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972860912858782859812856732860672859380.06
211.002866572870692868630.11
单位质量响应值RSD%判断
26065.4526078.450.04数据可信
供试品溶液-20220127批-阿齐沙坦-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%
5min157746-5774619.87422.9117.7319.8722.9117.75
282681-8268128.45628.46
363778-6377821.95021.95
459345-5934520.42420.42
580102-8010227.56827.57
655799-5579919.20419.20
10min1257506-25750688.62488.375.4188.7388.505.43
2277546-27754695.52195.68
3241914-24191483.25883.38
4244965-24496584.30884.42
5268270-26827092.32992.48
6250476-25047686.20586.31
15min1301049-301049103.610104.401.45104.21105.021.46
2309526-309526106.527107.22
3302463-302463104.097104.68
4297166-297166102.274102.86
5302939-302939104.260104.93
6306936-306936105.636106.22
20min1304033-304033104.637106.091.09105.82107.281.10
2311112-311112107.073108.35
3307546-307546105.846107.01
4304890-304890104.932106.08
5309700-309700106.587107.83
6312212-312212107.452108.62
30min1303506-303506104.456105.891.24106.22107.681.25
2310974-310974107.026108.90
3308611-308611106.212107.96
4302457-302457104.094105.83
5308931-308931106.323108.16
6311513-311513107.211108.98
45min1302007-302007103.940105.160.90106.28107.530.91
2309459-309459106.504108.97
3307417-307417105.802108.14
4303831-303831104.567106.88
5304079-304079104.653107.08
6306437-306437105.464107.83
60min1308512-308512106.178105.020.69109.10107.990.66
2305999-305999105.314108.38
3304822-304822104.908107.84
4304360-304360104.749107.64
5302148-302148103.988107.00
6305121-305121105.011107.96
极限1304566-304566104.820105.030.55108.33108.570.57
2306194-306194105.381109.03
3305929-305929105.289108.80
4302275-302275104.032107.51
5304963-304963104.957108.54
6307047-307047105.674109.21
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937176371714720587191372261719420.32
214.987220371993720980.21
单位质量响应值RSD%判断
4818.624812.950.09数据可信
供试品溶液-20220127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%
5min143142-4314258.08155.387.8458.0855.387.84
244585-4458560.02460.02
338043-3804351.21751.22
443380-4338058.40258.40
541139-4113955.38555.38
636507-3650749.14949.15
10min161470-6147082.75684.031.6483.0884.341.63
263804-6380485.89886.23
362896-6289684.67684.96
462304-6230483.87984.20
561065-6106582.21182.52
662967-6296784.77185.04
15min165608-6560888.32789.291.9589.1190.071.93
267707-6770791.15391.96
366706-6670689.80590.56
465477-6547788.15188.94
564647-6464787.03387.80
667805-6780591.28592.03
20min167495-6749590.86791.611.1892.1492.881.18
269086-6908693.00994.33
368275-6827591.91893.17
467834-6783491.32492.60
566913-6691390.08491.33
668689-6868992.47593.73
30min168787-6878792.60793.041.2394.3894.821.23
270548-7054894.97896.81
369239-6923993.21594.98
468688-6868892.47494.26
568030-6803091.58893.34
669352-6935293.36795.13
45min168851-6885192.69393.321.3794.9995.621.37
270757-7075795.25997.62
369666-6966693.79096.07
469080-6908093.00195.30
567935-6793591.46093.72
669615-6961593.72296.01
60min169944-6994494.16493.371.4096.9796.191.38
270042-7004294.29697.19
368986-6898692.87595.68
469908-6990894.11696.93
567549-6754990.94093.71
669711-6971193.85196.66
极限169630-6963093.74293.801.0697.0797.141.07
270410-7041094.79298.21
370205-7020594.51697.84
469872-6987294.06897.41
568311-6831191.96695.24
669625-6962593.73597.06
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972865122863452860582855532856872860310.15
211.002865522863102864310.06
单位质量响应值RSD%判断
26073.9326039.180.10数据可信
供试品溶液-555886批-阿齐沙坦-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%
5min19893-98933.40710.8353.023.4110.8353.00
224101-241018.3008.30
337295-3729512.84312.84
444439-4443915.30315.30
554036-5403618.60818.61
618895-188956.5076.51
10min1194678-19467867.04177.9210.9867.0677.9811.01
2214494-21449473.86573.91
3247854-24785485.35385.42
4245599-24559984.57684.66
5250953-25095386.42086.52
6203992-20399270.24870.28
15min1289220-28922099.59899.350.8799.9999.840.85
2284907-28490798.11298.57
3289605-28960599.730100.28
4289657-28965799.748100.30
5286083-28608398.51799.10
6291502-291502100.384100.81
20min1291543-291543100.39899.821.69101.34100.871.65
2284602-28460298.00799.01
3289696-28969699.762100.86
4294937-294937101.566102.68
5283675-28367597.68898.82
6294776-294776101.511102.50
30min1287720-28772099.08199.180.92100.58100.780.89
2285854-28585498.43999.98
3287567-28756799.028100.68
4289957-28995799.851101.52
5284920-28492098.11799.79
6292033-292033100.566102.11
45min1290437-290437100.01798.601.09102.07100.751.02
2283166-28316697.51399.61
3283910-28391097.76999.97
4285799-28579998.420100.65
5284769-28476998.065100.28
6289873-28987399.823101.93
60min1291406-291406100.35098.331.39102.96101.031.33
2282381-28238197.24399.88
3284520-28452097.979100.73
4288452-28845299.333102.11
5280658-28065896.64999.41
6285759-28575998.406101.07
极限1286914-28691498.80497.601.10101.97100.841.06
2280379-28037996.55399.73
3287146-28714698.883102.17
4282594-28259497.316100.64
5279909-27990996.39199.69
6283494-28349497.626100.83
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937216671648720647183871659718750.33
214.987212271800719610.32
单位质量响应值RSD%判断
4814.134803.810.16数据可信
供试品溶液-555886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%
5min120892-2089228.16641.7732.6428.1741.7732.64
245737-4573761.66261.66
337061-3706149.96549.97
433558-3355845.24345.24
529751-2975140.11040.11
618880-1888025.45425.45
10min165346-6534688.09990.081.3688.2690.311.43
267689-6768991.25891.60
367323-6732390.76491.04
467586-6758691.11991.37
566710-6671089.93890.16
666246-6624689.31289.45
15min170131-7013194.55095.130.9995.2095.860.95
270420-7042094.94095.79
370096-7009694.50395.28
470783-7078395.42996.19
570064-7006494.46095.18
671867-7186796.89197.53
20min171504-7150496.40196.471.8897.5797.731.83
271071-7107195.81797.19
371301-7130196.12897.43
472050-7205097.13798.43
569652-6965293.90495.15
673763-7376399.447100.62
30min170663-7066395.26796.081.4496.9797.881.40
271196-7119695.98697.90
370927-7092795.62397.46
470813-7081395.47097.30
570691-7069195.30597.07
673326-7332698.858100.59
45min171429-7142996.30095.791.4598.5498.131.37
270545-7054595.10897.55
370261-7026194.72597.10
470374-7037494.87897.24
570731-7073195.35997.66
672980-7298098.391100.67
60min171123-7112395.88894.651.9598.6697.521.89
270046-7004694.43697.41
370839-7083995.50598.40
469707-6970793.97896.86
567836-6783691.45694.28
671694-7169496.65799.48
极限169854-6985494.17794.481.3897.4897.871.33
269809-6980994.11697.61
370471-7047195.00998.44
468992-6899293.01596.42
569571-6957193.79597.13
671790-7179096.787100.15
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.972865442867882868792869442865502867410.07
211.002868982868442868710.02
单位质量响应值RSD%判断
26138.6526079.180.17数据可信
供试品溶液-555886批-阿齐沙坦-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%
5min138104-3810413.09514.0536.5513.1014.0536.54
220476-204767.0377.04
346874-4687416.10916.11
431900-3190010.96310.96
564746-6474622.25222.25
643117-4311714.81814.82
10min1222938-22293876.61881.075.2776.6981.145.30
2222276-22227676.39176.43
3248794-24879485.50585.59
4230424-23042479.19179.25
5249927-24992785.89486.02
6240924-24092482.80082.88
15min1292029-292029100.36399.510.95100.86100.040.96
2288557-28855799.17099.63
3291271-291271100.103100.67
4289576-28957699.520100.02
5291250-291250100.096100.70
6284566-28456697.79998.34
20min1291208-291208100.08199.680.76101.14100.770.75
2292496-292496100.524101.54
3288551-28855199.168100.29
4287844-28784498.92599.98
5292312-292312100.461101.62
6287897-28789798.943100.03
30min1290545-29054599.85399.280.80101.47100.920.80
2289651-28965199.546101.12
3287605-28760598.843100.51
4287516-28751698.812100.42
5292120-292120100.395102.11
6285897-28589798.25699.89
45min1286752-28675298.55098.630.43100.72100.820.46
2286526-28652698.472100.60
3286107-28610798.328100.55
4286200-28620098.360100.51
5289372-28937299.450101.72
6286994-28699498.633100.81
60min1289403-28940399.46197.711.86102.18100.441.83
2285057-28505797.967100.64
3288173-28817399.038101.81
4274960-27496094.49797.20
5286431-28643198.440101.26
6281806-28180696.85099.58
极限1282966-28296697.24997.530.57100.52100.800.56
2284415-28441597.747100.96
3284990-28499097.944101.26
4284801-28480197.879101.10
5284620-28462097.817101.19
6280842-28084296.51999.79
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.937204172244721597213871884720930.20
214.987195772163720600.21
单位质量响应值RSD%判断
4828.734810.410.27数据可信
供试品溶液-555886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%
5min156517-5651776.02849.0431.0376.0349.0431.03
238874-3887452.29452.29
339285-3928552.84752.85
430535-3053541.07741.08
526744-2674435.97735.98
626772-2677236.01436.01
10min169320-6932093.25190.802.1993.6791.072.25
267279-6727990.50690.80
368056-6805691.55191.84
468535-6853592.19592.42
566590-6659089.57989.78
665200-6520087.70987.91
15min173906-7390699.42195.952.71100.3696.722.76
270515-7051594.85995.65
371481-7148196.15896.96
472951-7295198.13698.88
570630-7063095.01495.71
668466-6846692.10292.79
20min174068-7406899.63896.252.27101.1397.562.32
271790-7179096.57497.89
370007-7000794.17595.51
472357-7235797.33798.62
571465-7146596.13797.36
669624-6962493.66094.86
30min174515-74515100.24096.862.24102.2998.702.30
271852-7185296.65798.51
371688-7168896.43798.30
472659-7265997.74399.57
571715-7171596.47398.23
669565-6956593.58195.30
45min174283-7428399.92896.332.55102.5398.722.60
270304-7030494.57596.97
371947-7194796.78599.18
472848-7284897.997100.37
571088-7108895.63097.93
669188-6918893.07495.31
60min175617-75617101.72295.923.46104.8898.843.48
270663-7066395.05897.98
372600-7260097.664100.60
469913-6991394.04996.96
570340-7034094.62397.45
668710-6871092.43195.19
极限174107-7410799.69195.473.12103.4198.923.15
270120-7012094.32797.77
371348-7134895.97999.46
472435-7243597.442100.88
570142-7014294.35797.71
667666-6766691.02694.30
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