阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914546745652455054551945526455340.16
211.994596045934459470.05
单位质量响应值RSD%判断
3823.173832.110.17数据可信
加速3月-供试品溶液-24051501批-左氨氯地平-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%
5min137507-3750779.19278.176.3679.1978.176.36
236153-3615376.33376.33
333973-3397371.73071.73
439693-3969383.80883.81
535178-3517874.27574.27
639641-3964183.69883.70
10min144476-4447693.90690.305.3294.3590.735.31
245284-4528495.61296.04
339447-3944783.28883.69
443740-4374092.35292.82
540639-4063985.80586.22
643010-4301090.81191.28
15min144735-4473594.45389.896.6895.4190.826.66
245220-4522095.47796.43
337601-3760179.39180.25
443347-4334791.52392.50
541007-4100786.58287.47
643534-4353491.91892.89
20min144282-4428293.49790.624.0494.9892.064.06
244764-4476494.51596.00
340601-4060185.72587.03
443561-4356191.97593.46
540972-4097286.50887.88
643334-4333491.49592.98
30min144078-4407893.06690.703.7895.0792.643.79
245323-4532395.69597.71
341026-4102686.62288.40
442954-4295490.69392.69
541366-4136687.34089.19
642993-4299390.77592.76
45min143492-4349291.82990.563.5494.3593.013.56
245041-4504195.09997.64
340976-4097686.51788.78
443632-4363292.12494.63
541371-4137187.35189.69
642848-4284890.46992.96
60min144205-4420593.33490.193.6596.3793.143.67
244525-4452594.01097.08
340749-4074986.03788.78
443173-4317391.15594.17
541125-4112586.83189.65
642512-4251289.76092.76
极限147299-4729999.867100.391.62103.42103.831.57
248409-48409102.211105.80
348202-48202101.774104.99
446536-4653698.256101.78
546840-4684098.898102.20
647986-47986101.317104.81
阿齐沙坦左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%
111.353873453872843872803873693875263873610.03
211.363892593890753891670.04
单位质量响应值RSD%判断
34128.7234257.660.27数据可信
加速3月-供试品溶液-24051501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%
5min1105788-10578827.76126.8615.7427.7626.8615.74
278275-7827520.54120.54
393687-9368724.58524.59
4123192-12319232.32832.33
597657-9765725.62725.63
6115558-11555830.32530.32
10min1250679-25067965.78465.864.8365.9466.014.85
2243126-24312663.80263.92
3238505-23850562.58962.73
4273378-27337871.74071.92
5247408-24740864.92565.07
6252679-25267966.30866.48
15min1272639-27263971.54672.572.7572.0773.082.76
2282415-28241574.11274.58
3266646-26664669.97470.46
4287562-28756275.46276.04
5272212-27221271.43471.94
6277694-27769472.87373.41
20min1280266-28026673.54874.642.5174.4775.562.52
2289648-28964876.01076.89
3278779-27877973.15874.03
4294907-29490777.39078.39
5276445-27644572.54573.45
6286408-28640875.16076.10
30min1290341-29034176.19277.551.9377.5278.891.93
2303430-30343079.62780.93
3290966-29096676.35677.64
4299599-29959978.62180.05
5290406-29040676.20977.51
6298444-29844478.31879.68
45min1296003-29600377.67879.722.2779.4381.482.27
2311668-31166881.78883.53
3298629-29862978.36780.07
4312067-31206781.89383.76
5299491-29949178.59380.32
6304842-30484279.99781.79
60min1307963-30796380.81681.351.4283.0083.561.44
2315254-31525482.72984.93
3305278-30527880.11282.25
4314120-31412082.43284.75
5305401-30540180.14482.31
6311916-31191681.85384.09
极限1372615-37261597.782100.051.58100.41102.711.57
2383248-383248100.573103.23
3386278-386278101.368103.95
4387670-387670101.733104.51
5375374-37537498.506101.11
6382349-382349100.337103.03
阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914572645762457494578345786457610.06
211.994578845634457110.24
单位质量响应值RSD%判断
3842.233812.430.56数据可信
加速3月-供试品溶液-24051501批-左氨氯地平-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%
5min141205-4120587.00890.013.6187.0190.013.61
242628-4262890.01390.01
341629-4162987.90487.90
441698-4169888.04988.05
543223-4322391.27091.27
645374-4537495.81295.81
10min146116-4611697.37895.552.7197.8696.052.70
245949-4594997.02697.53
343885-4388592.66793.16
443498-4349891.85092.34
546239-4623997.63898.15
645815-4581596.74397.28
15min145872-4587296.86394.593.0397.8995.623.02
244144-4414493.21494.25
343467-4346791.78592.79
443191-4319191.20292.20
545807-4580796.72697.78
646288-4628897.74298.81
20min146674-4667498.55796.362.89100.1297.912.87
245982-4598297.09598.65
343355-4335591.54893.06
444781-4478194.55996.07
546592-4659298.38499.97
646406-4640697.99199.60
30min145351-4535195.76394.682.7497.8796.782.73
245462-4546295.99798.09
343053-4305390.91192.93
443890-4389092.67894.71
544788-4478894.57496.71
646499-4649998.187100.34
45min143643-4364392.15692.752.3594.8095.372.35
244418-4441893.79396.42
342651-4265190.06292.59
442950-4295090.69393.24
544561-4456194.09596.75
645334-4533495.72798.43
60min145253-4525395.55692.973.2498.7196.103.21
244665-4466594.31597.47
341723-4172388.10291.13
442877-4287790.53993.59
544423-4442393.80496.99
645218-4521895.48298.72
极限147659-47659100.63799.122.29104.32102.772.29
246741-4674198.698102.37
345028-4502895.08198.60
446658-4665898.523102.08
547607-47607100.527104.23
647954-47954101.260105.02
阿齐沙坦左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%
111.353879673880313879283880303882973880510.04
211.363881113879093880100.04
单位质量响应值RSD%判断
34189.5234155.810.07数据可信
加速3月-供试品溶液-24051501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%
5min195400-9540025.05031.1810.6725.0531.1810.66
2132814-13281434.87434.87
3117221-11722130.78030.78
4119483-11948331.37431.37
5125392-12539232.92532.93
6122060-12206032.05032.05
10min1250232-25023265.70668.753.8865.8468.923.89
2268595-26859570.52770.72
3271705-27170571.34471.51
4251033-25103365.91666.09
5271975-27197571.41571.60
6257510-25751067.61767.79
15min1275686-27568672.38974.703.7272.8975.263.72
2282869-28286974.27574.86
3299859-29985978.73679.30
4274783-27478372.15272.69
5295133-29513377.49678.08
6278701-27870173.18173.73
20min1288273-28827375.69477.683.8776.6078.653.86
2290139-29013976.18477.18
3309712-30971281.32482.33
4288111-28811175.65276.59
5311391-31139181.76582.77
6287412-28741275.46876.43
30min1292952-29295276.92380.334.0078.2581.743.99
2298812-29881278.46279.88
3317820-31782083.45384.91
4302384-30238479.39980.76
5324137-32413785.11186.58
6299528-29952878.65080.03
45min1299137-29913778.54781.593.5980.3083.433.59
2302413-30241379.40781.26
3322555-32255584.69686.62
4306844-30684480.57182.37
5326431-32643185.71487.65
6306903-30690380.58682.40
60min1304192-30419279.87482.433.8282.0684.733.81
2301520-30152079.17381.47
3323607-32360784.97287.36
4311551-31155181.80784.06
5332770-33277087.37889.79
6309947-30994781.38583.65
极限1374141-37414198.24198.272.05100.88101.032.04
2367049-36704996.37999.12
3389156-389156102.184105.05
4371752-37175297.614100.32
5372170-37217097.724100.62
6371238-37123897.479100.20
阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914559645636456034551745508455720.13
211.994552445567455460.07
单位质量响应值RSD%判断
3826.363798.670.52数据可信
加速3月-供试品溶液-24051502批-左氨氯地平-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%
5min139045-3904582.76884.005.5382.7784.005.53
235417-3541775.07775.08
340595-4059586.05386.05
440693-4069386.26186.26
540818-4081886.52686.53
641188-4118887.31087.31
10min145220-4522095.85794.222.7996.3294.682.78
243664-4366492.55992.98
342930-4293091.00391.48
444270-4427093.84494.32
546453-4645398.47198.95
644138-4413893.56494.05
15min144988-4498895.36693.672.6596.3694.662.64
243168-4316891.50792.44
343180-4318091.53392.52
444085-4408593.45194.45
546123-4612397.77298.80
643586-4358692.39493.40
20min144310-4431093.92893.683.0595.4595.193.04
243058-4305891.27492.71
343025-4302591.20492.70
444264-4426493.83195.35
546686-4668698.965100.54
643803-4380392.85494.37
30min144820-4482095.00993.723.5997.0595.763.57
242971-4297191.09093.04
342474-4247490.03692.04
444087-4408793.45695.50
546965-4696599.556101.68
643958-4395893.18295.22
45min143318-4331891.82592.483.2894.4095.043.27
242104-4210489.25291.70
342606-4260690.31692.82
443862-4386292.97995.54
546209-4620997.954100.63
643673-4367392.57895.13
60min144518-4451894.36992.723.4397.4595.783.41
242484-4248490.05893.01
342327-4232789.72592.73
443635-4363592.49795.57
546326-4632698.202101.42
643145-4314591.45994.52
极限147019-4701999.67199.091.85103.28102.671.87
246401-4640198.361101.81
345669-4566996.809100.31
446165-4616597.861101.45
548120-48120102.005105.77
647093-4709399.828103.40
阿齐沙坦左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%
111.353858043857603857103858763858023857900.02
211.363855883853203854540.05
单位质量响应值RSD%判断
33990.3133930.810.13数据可信
加速3月-供试品溶液-24051502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%
5min1109235-10923528.86227.486.1328.8627.486.12
2106501-10650128.14028.14
3104938-10493827.72727.73
4110783-11078329.27129.27
597646-9764625.80025.80
694963-9496325.09125.09
10min1263010-26301069.49268.232.7069.6568.382.70
2257902-25790268.14268.30
3257411-25741168.01368.17
4255360-25536067.47167.63
5268100-26810070.83770.98
6247599-24759965.42065.56
15min1279898-27989873.95474.102.4874.5074.632.46
2274823-27482372.61373.15
3290093-29009376.64877.18
4273680-27368072.31172.85
5287724-28772476.02276.56
6276407-27640773.03273.53
20min1281487-28148774.37475.872.5375.3376.812.51
2280660-28066074.15675.09
3298395-29839578.84179.80
4283430-28343074.88775.83
5293815-29381577.63178.59
6285086-28508675.32576.23
30min1295166-29516677.98878.481.9779.3679.841.95
2290150-29015076.66378.01
3304137-30413780.35981.75
4291192-29119276.93878.29
5302543-30254379.93781.33
6298965-29896578.99280.32
45min1299132-29913279.03680.402.3180.8482.202.29
2299853-29985379.22781.00
3316916-31691683.73585.58
4298393-29839378.84180.62
5304913-30491380.56482.40
6306529-30652980.99182.76
60min1303385-30338580.16081.942.2182.4084.182.19
2305516-30551680.72382.94
3321287-32128784.89087.20
4304808-30480880.53682.76
5312412-31241282.54584.83
6313210-31321082.75684.97
极限1372593-37259398.44699.192.44101.13101.892.42
2371840-37184098.247100.91
3391445-391445103.427106.21
4365252-36525296.50699.17
5379892-379892100.374103.12
6371365-37136598.121100.80
阿齐沙坦左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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.914561445581456144559345610456020.04
211.994566045590456250.11
单位质量响应值RSD%判断
3828.883805.250.44数据可信
加速3月-供试品溶液-24051502批-左氨氯地平-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%
5min140550-4055085.85587.982.7485.8687.982.75
240809-4080986.40386.40
341451-4145187.76387.76
440632-4063286.02986.03
542591-4259190.17690.18
643280-4328091.63591.64
10min144506-4450694.23195.862.1194.7196.342.11
246098-4609897.60298.08
345469-4546996.27096.76
444041-4404193.24693.72
544972-4497295.21895.72
646554-4655498.56799.08
15min145235-4523595.77496.611.7996.7797.641.79
246571-4657198.60399.63
345209-4520995.71996.74
444831-4483194.91995.91
545194-4519495.68896.72
646749-4674998.980100.04
20min145649-4564996.65196.111.7798.1897.661.76
246056-4605697.51399.08
345383-4538396.08897.64
444110-4411093.39294.92
544868-4486894.99796.56
646284-4628497.99599.60
30min145316-4531695.94695.911.7498.0298.001.74
245662-4566296.67898.79
345343-4534396.00398.09
443909-4390992.96795.01
545268-4526895.84497.93
646305-4630598.040100.19
45min143318-4331891.71693.281.9394.3295.901.92
244620-4462094.47297.12
343969-4396993.09495.72
442908-4290890.84893.41
544302-4430293.79996.42
645211-4521195.72498.42
60min143598-4359892.30893.182.5295.4296.322.49
245462-4546296.25599.43
343585-4358592.28195.42
442562-4256290.11593.18
543643-4364392.40495.55
645199-4519995.69898.93
极限146698-4669898.87299.891.36102.50103.561.37
247825-47825101.258104.97
346979-4697999.467103.12
446431-4643198.307101.87
547089-4708999.700103.36
648060-48060101.756105.51
阿齐沙坦左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%
111.353858623861513859353861643859903860200.04
211.363869373865933867650.07
单位质量响应值RSD%判断
34010.5734046.210.08数据可信
加速3月-供试品溶液-24051502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%
5min1106211-10621128.00727.415.3428.0127.415.33
2108171-10817128.52428.52
3109953-10995328.99428.99
4104994-10499427.68627.69
596239-9623925.37725.38
698102-9810225.86925.87
10min1254547-25454767.12267.763.1567.2867.923.15
2259856-25985668.52268.68
3267037-26703770.41570.58
4245239-24523964.66764.82
5251575-25157566.33866.48
6263579-26357969.50469.65
15min1284264-28426474.95874.962.6975.4975.482.68
2284926-28492675.13375.67
3291014-29101476.73877.29
4269548-26954871.07871.59
5286941-28694175.66476.17
6288856-28885676.16976.70
20min1293688-29368877.44376.672.6278.3977.612.62
2288206-28820675.99876.95
3299980-29998079.10280.08
4277264-27726473.11274.02
5293029-29302977.26978.20
6292286-29228677.07378.03
30min1303680-30368080.07878.942.9381.4580.302.92
2295034-29503477.79879.18
3309054-30905481.49582.91
4283971-28397174.88176.19
5301729-30172979.56380.92
6302611-30261179.79681.18
45min1305474-30547480.55179.222.4782.3781.042.46
2297989-29798978.57780.39
3306099-30609980.71682.59
4286961-28696175.66977.40
5305875-30587580.65782.46
6300255-30025579.17581.00
60min1311057-31105782.02381.092.1784.2983.342.18
2308899-30889981.45483.70
3313800-31380082.74685.07
4294605-29460577.68579.84
5308618-30861881.38083.63
6308101-30810181.24483.51
极限1372010-37201098.09699.523.01100.82102.222.98
2379406-379406100.046102.75
3388808-388808102.525105.30
4359237-35923794.72897.31
5389496-389496102.707105.41
6375455-37545599.004101.72
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