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%
111.132950272952642954152953942947222951640.10
211.192934262940212937240.15
单位质量响应值RSD%判断
26519.6826248.790.73数据可信
供试品溶液-第3批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117283-172835.8784.5124.715.884.5124.70
29434-94343.2083.21
317323-173235.8925.89
411702-117023.9803.98
511659-116593.9653.97
612127-121274.1244.12
10min192925-9292531.60433.416.9031.6433.436.90
293835-9383531.91331.93
3110342-11034237.52737.56
494483-9448332.13432.16
5102036-10203634.70234.72
695711-9571132.55132.57
15min1176035-17603559.86958.272.1460.0858.482.14
2168688-16868857.37157.57
3173741-17374159.08959.33
4166793-16679356.72656.93
5169022-16902257.48457.70
6173741-17374159.08959.29
20min1209450-20945071.23468.822.5171.7769.362.50
2198084-19808467.36867.88
3204124-20412469.42269.99
4198795-19879567.61068.13
5197178-19717867.06067.59
6206535-20653570.24270.77
30min1229090-22909077.91376.312.0978.8577.232.10
2219233-21923374.56175.45
3226323-22632376.97277.93
4220774-22077475.08575.98
5220867-22086775.11776.02
6230040-23004078.23679.16
45min1249678-24967884.91582.632.1486.2883.972.13
2239330-23933081.39682.70
3241885-24188582.26583.65
4235667-23566780.15081.46
5243689-24368982.87884.20
6247527-24752784.18485.54
60min1268063-26806391.16889.761.0193.0191.561.01
2264659-26465990.01091.76
3263428-26342889.59191.43
4262729-26272989.35491.11
5259995-25999588.42490.21
6264706-26470690.02691.85
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%
114.957035670607707447029070517705030.27
214.887006370089700760.03
单位质量响应值RSD%判断
4715.924709.410.10数据可信
供试品溶液-第3批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132254-3225444.37342.1316.0544.3742.1316.05
235852-3585249.32349.32
336498-3649850.21250.21
425317-2531734.83034.83
527442-2744237.75337.75
626387-2638736.30236.30
10min151469-5146970.80875.384.6071.0575.614.55
252498-5249872.22472.50
354307-5430774.71274.99
458184-5818480.04680.24
556012-5601277.05877.27
656282-5628277.43077.63
15min168112-6811293.70594.064.0294.3494.713.99
266581-6658191.59892.27
367306-6730692.59693.29
473756-73756101.469102.11
568126-6812693.72494.36
666321-6632191.24191.87
20min170890-7089097.52696.314.6798.6997.484.62
266771-6677191.86093.04
369164-6916495.15296.36
476084-76084104.672105.87
568876-6887694.75695.91
668233-6823393.87195.01
30min171848-7184898.84497.464.49100.5599.174.45
267726-6772693.17494.87
370955-7095597.61699.35
476344-76344105.030106.81
570378-7037896.82298.51
667813-6781393.29394.95
45min172418-7241899.62998.223.58101.88100.473.56
268341-6834194.02096.23
371036-7103697.727100.01
475561-75561103.952106.32
571757-7175798.719100.94
669236-6923695.25197.43
60min172596-7259699.87398.284.33102.68101.084.28
269599-6959995.75098.48
369639-6963995.80598.63
477278-77278106.315109.26
569989-6998996.28799.06
669546-6954695.67798.39
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%
111.132952812957262957062956052954552955550.07
211.192956002957562956780.04
单位质量响应值RSD%判断
26554.8126423.410.36数据可信
供试品溶液-第3批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116923-169235.7334.8817.855.734.8817.82
216651-166515.6405.64
312296-122964.1654.17
414670-146704.9694.97
515556-155565.2705.27
610422-104223.5303.53
10min1101814-10181434.48933.762.3434.5233.792.36
2102339-10233934.66734.70
396533-9653332.70032.72
4100133-10013333.92033.95
599783-9978333.80133.83
697362-9736232.98133.00
15min1171547-17154758.11159.693.5458.3359.913.54
2180643-18064361.19261.42
3166560-16656056.42156.63
4179729-17972960.88261.10
5183079-18307962.01762.23
6175765-17576559.54059.74
20min1203014-20301468.77070.603.3469.3271.153.34
2212841-21284172.09972.66
3198718-19871867.31567.83
4210668-21066871.36371.92
5218022-21802273.85474.42
6207233-20723370.19970.73
30min1225158-22515876.27178.582.3977.2079.522.39
2234387-23438779.39780.36
3224707-22470776.11877.01
4236762-23676280.20281.15
5236242-23624280.02681.00
6234585-23458579.46580.39
45min1242900-24290082.28184.292.4883.6385.662.48
2251006-25100685.02786.43
3239399-23939981.09582.41
4251948-25194885.34686.74
5253321-25332185.81187.23
6254408-25440886.17987.54
60min1260854-26085488.36391.122.8690.1792.962.85
2274883-27488393.11594.99
3257578-25757887.25389.02
4274102-27410292.85194.72
5273836-27383692.76194.65
6272763-27276392.39794.24
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%
114.957073870381703077064770540705230.26
214.887063770505705710.14
单位质量响应值RSD%判断
4717.264742.670.38数据可信
供试品溶液-第3批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131716-3171643.47444.987.7943.4744.987.78
233765-3376546.28246.28
334518-3451847.31447.31
428071-2807138.47738.48
534522-3452247.32047.32
634283-3428346.99246.99
10min151737-5173770.91776.194.2671.1676.444.26
255408-5540875.94976.21
358907-5890780.74581.01
454948-5494875.31875.53
556895-5689577.98778.25
655604-5560476.21776.48
15min166103-6610390.60995.123.2691.2495.793.26
272462-7246299.325100.00
371202-7120297.59898.31
468328-6832893.65994.29
569719-6971995.56596.26
668535-6853593.94294.63
20min166786-6678691.54596.563.8592.6897.763.85
273287-73287100.456101.69
373467-73467100.703101.96
469260-6926094.93696.09
571381-7138197.84399.07
668486-6848693.87595.08
30min165859-6585990.27497.084.5391.9298.824.52
273523-73523100.779102.57
374709-74709102.405104.22
468799-6879994.30495.98
570701-7070196.91198.68
671369-7136997.82799.55
45min169018-6901894.60498.952.5296.75101.232.53
273714-73714101.041103.39
373876-73876101.263103.65
472408-7240899.251101.45
571313-7131397.750100.06
672811-7281199.803102.07
60min168600-6860094.03199.202.8496.71102.032.84
274487-74487102.101105.01
373872-73872101.258104.20
472520-7252099.405102.16
572259-7225999.047101.90
672506-7250699.385102.21
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%
111.132937332956152958652950462938502948220.34
211.192947912926382937140.52
单位质量响应值RSD%判断
26488.9526247.900.65数据可信
供试品溶液-第4批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113382-133824.5546.3517.534.556.3517.56
218144-181446.1746.17
320034-200346.8186.82
422081-220817.5147.51
516823-168235.7255.72
621563-215637.3387.34
10min181306-8130627.66829.323.6827.6929.363.68
286322-8632229.37529.41
388131-8813129.99130.03
484345-8434528.70328.74
590542-9054230.81130.84
686368-8636829.39129.43
15min1169207-16920757.58157.172.2557.7657.372.24
2167644-16764457.04957.25
3164482-16448255.97356.18
4171858-17185858.48358.68
5162858-16285855.42155.62
6172011-17201158.53558.74
20min1203134-20313469.12769.072.1469.6369.592.13
2204471-20447169.58270.10
3199021-19902167.72768.24
4203925-20392569.39669.92
5197591-19759167.24067.75
6209736-20973671.37371.90
30min1224317-22431776.33576.411.5277.2277.311.52
2225652-22565276.78977.69
3222985-22298575.88276.77
4224449-22444976.38077.29
5219731-21973174.77575.66
6230080-23008078.29679.22
45min1248531-24853184.57584.791.8285.8886.111.82
2247821-24782184.33485.66
3246155-24615583.76785.08
4249432-24943284.88286.22
5245170-24517083.43184.73
6257845-25784587.74589.11
60min1263278-26327889.59489.302.0091.3791.101.99
2261840-26184089.10490.90
3258744-25874488.05189.83
4260616-26061688.68890.50
5257736-25773687.70889.47
6272283-27228392.65894.51
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%
114.957068170823705947028870091704950.43
214.887060470388704960.22
单位质量响应值RSD%判断
4715.384737.630.34数据可信
供试品溶液-第4批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min122322-2232230.62039.0616.5330.6239.0616.52
226716-2671636.64736.65
326402-2640236.21636.22
435956-3595649.32249.32
531506-3150643.21743.22
627947-2794738.33538.34
10min144002-4400260.35864.204.8660.5364.424.90
244754-4475461.39061.59
346430-4643063.68963.89
450202-5020268.86369.14
547264-4726464.83365.07
648175-4817566.08366.30
15min168646-6864694.16394.521.7394.6795.101.74
269211-6921194.93895.48
368183-6818393.52894.08
470076-7007696.12596.78
570224-7022496.32896.93
667108-6710892.05392.63
20min169898-6989895.88096.682.1196.9197.782.11
271092-7109297.51898.59
370183-7018396.27197.35
470669-7066996.93898.13
572786-7278699.842100.98
668280-6828093.66194.75
30min170516-7051696.72896.982.0398.2998.612.03
270256-7025696.37297.99
370774-7077497.08298.69
470905-7090597.26298.99
573094-73094100.264101.95
668636-6863694.14995.76
45min171072-7107297.49196.753.1299.5998.923.09
266831-6683191.67393.82
371563-7156398.164100.31
471208-7120897.67799.95
573210-73210100.424102.67
669297-6929795.05697.19
60min171327-7132797.84197.551.36100.48100.261.33
272194-7219499.030101.69
370834-7083497.16499.86
470554-7055496.78099.59
572103-7210398.905101.71
669679-6967995.58098.24
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%
111.132962232959932963942959342948192958730.21
211.192954862953892954380.03
单位质量响应值RSD%判断
26583.3826401.970.49数据可信
供试品溶液-第4批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117952-179526.0806.2521.036.086.2521.04
217656-176565.9805.98
313574-135744.5984.60
422120-221207.4927.49
523812-238128.0658.07
615560-155605.2705.27
10min180552-8055227.28328.403.1827.3228.433.19
283146-8314628.16228.19
384307-8430728.55528.58
487664-8766429.69229.73
585838-8583829.07329.12
681525-8152527.61327.64
15min1172254-17225458.34356.483.2158.5356.673.21
2159120-15912053.89454.08
3166344-16634456.34156.53
4172996-17299658.59458.80
5162829-16282955.15055.36
6166967-16696756.55256.73
20min1211036-21103671.47868.823.2171.9969.333.21
2193099-19309965.40365.89
3204248-20424869.17969.68
4208601-20860170.65371.19
5198870-19887067.35867.87
6203275-20327568.85069.35
30min1233295-23329579.01776.122.8479.9277.012.84
2217345-21734573.61574.47
3223822-22382275.80976.69
4231167-23116778.29779.22
5219027-21902774.18575.07
6223856-22385675.82076.70
45min1256582-25658286.90583.892.6388.2585.202.63
2237930-23793080.58781.85
3247628-24762883.87285.17
4252270-25227085.44486.80
5243694-24369482.53983.84
6248027-24802784.00785.31
60min1272198-27219892.19488.542.9794.0290.322.96
2251794-25179485.28386.99
3261600-26160088.60490.37
4267633-26763390.64892.48
5254125-25412586.07287.83
6261138-26113888.44890.22
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%
114.957086570564703557101870537706680.38
214.887068270573706280.11
单位质量响应值RSD%判断
4726.964746.510.30数据可信
供试品溶液-第4批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127078-2707837.06338.5315.1337.0638.5315.13
227388-2738837.48837.49
325710-2571035.19135.19
432444-3244444.40844.41
533817-3381746.28746.29
622456-2245630.73730.74
10min146518-4651863.67262.654.0163.8862.874.04
245144-4514461.79162.00
342880-4288058.69258.89
447375-4737564.84565.09
547817-4781765.45065.71
644902-4490261.46061.63
15min169393-6939394.98292.913.2795.5493.483.23
267000-6700091.70792.26
366109-6610990.48791.01
469528-6952895.16795.77
564848-6484888.76189.38
670416-7041696.38296.89
20min169676-6967695.37096.621.6896.4697.701.68
269204-6920494.72495.78
369839-6983995.59396.62
471218-7121897.48098.62
571365-7136597.68198.80
672238-7223898.87699.92
30min171168-7116897.41297.771.4699.0399.381.48
270507-7050796.50798.09
369964-6996495.76497.32
472472-7247299.197100.87
572263-7226398.911100.57
672184-7218498.802100.40
45min171733-7173398.18598.001.78100.34100.161.79
269853-6985395.61297.74
370214-7021496.10698.19
472923-7292399.814102.04
572457-7245799.176101.38
672400-7240099.098101.24
60min170669-7066996.72997.871.7299.43100.571.71
270261-7026196.17098.82
370869-7086997.00399.62
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