厄贝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左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.843211731940318433192132050319740.35
214.013181031784317970.06
单位质量响应值RSD%判断
2310.262269.591.26数据可信
供试品溶液-24032501批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136348-36348100.22799.330.80100.2399.330.80
236093-3609399.52499.52
336189-3618999.78899.79
435533-3553397.97997.98
535860-3586098.88198.88
636118-3611899.59399.59
10min136554-36554100.795101.831.81101.35102.381.80
237077-37077102.237102.79
336638-36638101.026101.58
436047-3604799.39799.94
537317-37317102.899103.45
637952-37952104.650105.20
15min135541-3554198.002101.132.1299.12102.252.10
237022-37022102.085103.21
337001-37001102.027103.14
435894-3589498.975100.07
537078-37078102.240103.36
637518-37518103.453104.59
20min136580-36580100.867101.601.53102.53103.281.53
236538-36538100.751102.44
337053-37053102.171103.85
436062-3606299.438101.08
537205-37205102.590104.28
637639-37639103.787105.50
30min135766-3576698.62299.791.49100.84102.041.49
236327-36327100.169102.42
336123-3612399.606101.86
435480-3548097.833100.03
536434-36434100.464102.72
637017-37017102.072104.36
45min135727-3572798.51499.641.60101.28102.431.59
235959-3595999.154101.96
335906-3590699.008101.81
435604-3560498.175100.92
536459-36459100.533103.35
637147-37147102.430105.28
60min135483-3548397.84298.421.37101.16101.771.37
235775-3577598.647102.00
335554-3555498.037101.39
434943-3494396.35399.64
536052-3605299.411102.79
636343-36343100.213103.64
极限135245-3524597.18599.102.43101.05103.002.39
236125-3612599.612103.52
336221-3622199.877103.77
434558-3455895.29199.11
536741-36741101.310105.24
636754-36754101.346105.33
厄贝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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982069934206952020689872063511206142620666760.19
215.102062207205816120601840.14
单位质量响应值RSD%判断
137962.35136436.030.79数据可信
供试品溶液-24032501批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1264186-26418611.55410.885.4311.5510.885.43
2255873-25587311.19011.19
3250199-25019910.94210.94
4257417-25741711.25811.26
5237180-23718010.37310.37
6228492-2284929.9939.99
10min1512940-51294022.43321.742.3722.5021.802.37
2504934-50493422.08222.14
3487279-48727921.31021.37
4503453-50345322.01822.08
5492105-49210521.52121.58
6482472-48247221.10021.16
15min1650328-65032828.44128.591.2728.6328.781.28
2662661-66266128.98029.17
3653061-65306128.56128.74
4662311-66231128.96529.15
5654018-65401828.60228.78
6640396-64039628.00728.18
20min1792222-79222234.64733.961.5634.9934.301.57
2777215-77721533.99034.34
3775087-77508733.89734.24
4784485-78448534.30834.65
5773467-77346733.82634.16
6756232-75623233.07333.40
30min1950748-95074841.57940.831.6742.1241.361.67
2949013-94901341.50442.04
3927507-92750740.56341.09
4941173-94117341.16141.70
5918534-91853440.17140.69
6914720-91472040.00440.52
45min11124251-112425149.16748.461.2049.9449.221.21
21119094-111909448.94249.71
31099480-109948048.08448.84
41116039-111603948.80849.57
51094279-109427947.85748.60
61095461-109546147.90848.64
60min11247216-124721654.54553.621.3555.5954.641.36
21239464-123946454.20655.24
31218765-121876553.30154.32
41232168-123216853.88754.92
51215038-121503853.13854.15
61203265-120326552.62353.62
极限11329938-132993858.16357.721.2359.5159.051.22
21338442-133844258.53559.87
31326299-132629958.00459.32
41302891-130289156.98058.32
51324487-132448757.92459.23
61297333-129733356.73758.03
厄贝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左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.843191832058318893198931713319130.41
214.013189431954319240.14
单位质量响应值RSD%判断
2305.852278.660.84数据可信
供试品溶液-24032501批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135535-3553597.88195.155.9797.8895.155.97
234806-3480695.87395.87
336233-3623399.80499.80
430638-3063884.39284.39
534128-3412894.00694.01
635914-3591498.92598.93
10min137089-37089102.162100.022.23102.71100.542.23
235320-3532097.28997.82
335684-3568498.29298.85
435752-3575298.47998.95
536984-36984101.872102.39
637030-37030101.999102.55
15min135973-3597399.08899.521.21100.20100.601.20
235676-3567698.27099.34
335982-3598299.112100.21
435872-3587298.80999.83
536869-36869101.556102.64
636404-36404100.275101.39
20min136054-3605499.31199.661.58100.97101.301.57
235352-3535297.37799.00
335854-3585498.760100.41
436196-3619699.702101.27
536746-36746101.217102.87
636891-36891101.616103.29
30min135568-3556897.97299.761.41100.19101.951.38
236238-3623899.818101.98
336111-3611199.468101.67
436063-3606399.336101.45
537130-37130102.275104.49
636182-3618299.663101.90
45min135886-3588698.84899.271.37101.61102.011.37
235451-3545197.650100.36
335754-3575498.484101.24
435886-3588698.848101.52
536788-36788101.333104.12
636462-36462100.435103.23
60min135985-3598599.12198.481.34102.43101.781.33
235172-3517296.881100.14
335285-3528597.193100.49
435572-3557297.983101.20
536297-3629799.980103.33
636198-3619899.707103.06
极限135679-3567998.27898.091.48102.14101.941.45
234676-3467695.51599.31
335396-3539697.498101.34
435806-3580698.628102.39
536135-3613599.534103.44
635975-3597599.093103.00
厄贝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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982061926205703820573602057744204809020564320.25
215.102060432205484820576400.20
单位质量响应值RSD%判断
137278.50136267.550.53数据可信
供试品溶液-24032501批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1256807-25680711.26610.7912.6811.2710.7912.68
2245283-24528310.76010.76
3286075-28607512.55012.55
4199909-1999098.7708.77
5221287-2212879.7089.71
6266025-26602511.67011.67
10min1501025-50102521.97921.094.3122.0421.154.32
2478267-47826720.98121.04
3489195-48919521.46021.53
4450509-45050919.76319.81
5463503-46350320.33320.39
6501690-50169022.00922.07
15min1647607-64760728.41027.762.5428.5927.942.56
2636639-63663927.92928.10
3638342-63834228.00328.19
4609958-60995826.75826.92
5616544-61654427.04727.21
6648171-64817128.43528.62
20min1766127-76612733.60932.752.3333.9533.082.34
2741932-74193232.54832.88
3739036-73903632.42132.77
4732807-73280732.14732.45
5729585-72958532.00632.32
6770312-77031233.79334.14
30min1925690-92569040.60940.151.4541.1440.661.46
2931799-93179940.87741.39
3905951-90595139.74340.27
4898922-89892239.43539.92
5906232-90623239.75540.25
6922676-92267640.47741.01
45min11104042-110404248.43347.451.4749.1948.191.48
21078930-107893047.33148.07
31066582-106658246.79047.54
41075497-107549747.18147.89
51067137-106713746.81447.53
61098033-109803348.16948.93
60min11236725-123672554.25452.501.9755.2853.501.96
21192971-119297152.33453.34
31172653-117265351.44352.45
41183648-118364851.92552.89
51183306-118330651.91052.89
61211330-121133053.14054.17
极限11317292-131729257.78855.881.9059.1157.171.89
21251305-125130554.89356.19
31254988-125498855.05556.35
41274481-127448155.91057.17
51263041-126304155.40856.67
61281579-128157956.22157.54
厄贝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左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.843174731851319253167831961318320.38
214.013214531844319940.67
单位质量响应值RSD%判断
2300.002283.650.51数据可信
供试品溶液-24032502批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135494-3549497.78497.852.7097.7897.852.70
235325-3532597.31997.32
335203-3520396.98396.98
437371-37371102.955102.96
534604-3460495.33295.33
635111-3511196.72996.73
10min137179-37179102.426102.491.93102.97103.041.93
236955-36955101.809102.35
336385-36385100.239100.78
438509-38509106.091106.66
536860-36860101.548102.08
637332-37332102.848103.39
15min137705-37705103.876102.321.45104.99103.431.45
237479-37479103.253104.36
336434-36434100.374101.47
437401-37401103.038104.20
536496-36496100.545101.64
637321-37321102.818103.93
20min136646-36646100.958101.051.18102.65102.731.17
237266-37266102.666104.35
336268-3626899.917101.57
436502-36502100.561102.30
536258-3625899.889101.54
637138-37138102.313103.99
30min136563-36563100.729100.232.44102.98102.472.40
236941-36941101.771104.02
336285-3628599.963102.17
437444-37444103.156105.45
536234-3623499.823102.03
634825-3482595.94198.19
45min137445-37445103.159100.322.46105.97103.122.42
236925-36925101.727104.54
336599-36599100.829103.59
436880-36880101.603104.47
535318-3531897.299100.06
635311-3531197.280100.06
60min138058-38058104.848101.711.91108.23105.061.88
236443-36443100.399103.78
336260-3626099.895103.22
437363-37363102.933106.36
536359-36359100.167103.47
637027-37027102.008105.33
极限137156-37156102.363101.190.66106.33105.110.66
236606-36606100.848104.79
336451-36451100.421104.30
436755-36755101.258105.26
536641-36641100.944104.80
636775-36775101.313105.20
厄贝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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982047146204528820582542045340205709020506240.32
215.102067517205359020605540.48
单位质量响应值RSD%判断
136890.79136460.530.23数据可信
供试品溶液-24032502批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1289257-28925712.69812.555.3312.7012.555.33
2290189-29018912.73912.74
3293164-29316412.87012.87
4298563-29856313.10713.11
5288508-28850812.66512.67
6255719-25571911.22611.23
10min1527749-52774923.16823.102.5323.2423.172.54
2528712-52871223.21023.28
3521891-52189122.91122.98
4545933-54593323.96624.04
5528300-52830023.19223.26
6504668-50466822.15522.22
15min1695579-69557930.53630.081.6530.7330.281.65
2698777-69877730.67630.88
3681770-68177029.92930.13
4689042-68904230.24930.45
5676076-67607629.68029.88
6669940-66994029.41029.60
20min1802322-80232235.22235.011.0035.5935.380.99
2810861-81086135.59735.97
3794137-79413734.86235.23
4788349-78834934.60834.98
5795717-79571734.93235.30
6794116-79411634.86135.21
30min1963232-96323242.28642.302.6142.8542.862.59
2980179-98017943.03043.60
3970472-97047242.60343.16
4986210-98621043.29443.86
5965662-96566242.39242.95
6915576-91557640.19340.74
45min11177209-117720951.67950.382.5652.4851.172.54
21170345-117034551.37852.18
31163627-116362751.08351.88
41149689-114968950.47151.28
51121038-112103849.21350.01
61103431-110343148.44049.21
60min11325627-132562758.19556.821.2359.2857.901.21
21282899-128289956.31957.41
31284240-128424056.37857.46
41291688-129168856.70557.79
51288045-128804556.54557.61
61293644-129364456.79157.83
极限11386217-138621760.85460.480.7762.2661.870.75
21372648-137264860.25961.66
31380885-138088560.62062.01
41361855-136185559.78561.19
51391208-139120861.07462.45
61373792-137379260.30961.66
厄贝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左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
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%
113.843190731688318473170031795317870.30
214.013186131867318640.02
单位质量响应值RSD%判断
2296.752274.380.70数据可信
供试品溶液-24032502批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135046-3504696.81696.252.9396.8296.252.93
235322-3532297.57897.58
335619-3561998.39998.40
435518-3551898.12098.12
534661-3466195.75295.75
632886-3288690.84990.85
10min135661-3566198.515101.711.8699.05102.251.86
237258-37258102.927103.47
337583-37583103.824104.37
437153-37153102.637103.18
536501-36501100.835101.37
636755-36755101.537102.04
15min135979-3597999.393101.301.11100.48102.401.11
236682-36682101.335102.45
337131-37131102.576103.70
436808-36808101.683102.80
536475-36475100.764101.86
636946-36946102.065103.13
20min135813-3581398.935101.461.91100.57103.121.88
236547-36547100.962102.64
336905-36905101.951103.64
437227-37227102.841104.52
536164-3616499.904101.56
637714-37714104.186105.82
30min135690-3569098.595100.391.30100.78102.611.30
236471-36471100.752102.99
336746-36746101.512103.77
436458-36458100.717102.97
535834-3583498.993101.20
636830-36830101.744103.96
45min135373-3537397.719101.232.07100.45104.012.05
236315-36315100.322103.12
337576-37576103.805106.63
437082-37082102.440105.25
536579-36579101.051103.81
636937-36937102.040104.82
60min135137-3513797.067100.252.17100.34103.592.14
237083-37083102.443105.80
336850-36850101.799105.20
436937-36937102.040105.42
535770-3577098.816102.13
635955-3595599.327102.67
极限134523-3452395.37198.801.8499.19102.701.82
236288-36288100.247104.17
335856-3585699.054103.02
436229-36229100.084104.03
535610-3561098.374102.24
636073-3607399.653103.55
厄贝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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
114.982058857204820420486552045624204701220496700.26
215.102059478205489420571860.16
单位质量响应值RSD%判断
136827.10136237.480.31数据可信
供试品溶液-24032502批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1284629-28462912.50812.005.4712.5112.005.48
2295499-29549912.98612.99
3270964-27096411.90811.91
4253949-25394911.16011.16
5262989-26298911.55711.56
6270485-27048511.88711.89
10min1517258-51725822.73122.661.7922.8022.731.80
2529472-52947223.26823.34
3522329-52232922.95423.02
4504350-50435022.16422.23
5509224-50922422.37822.44
6511396-51139622.47422.54
15min1679897-67989729.87929.591.0030.0729.781.01
2675854-67585429.70129.90
3677973-67797329.79429.99
4663283-66328329.14929.33
5666710-66671029.29929.49
6676112-67611229.71229.90
20min1796401-79640134.99934.871.3235.3635.231.31
2789772-78977234.70735.07
3792679-79267934.83535.19
4787987-78798734.62934.98
5781881-78188134.36034.71
6812303-81230335.69736.05
30min1967422-96742242.51442.151.2643.0742.701.26
2949979-94997941.74842.31
3967121-96712142.50143.05
4951496-95149641.81442.35
5944610-94461041.51242.05
6974708-97470842.83443.39
45min11139340-113934050.06950.581.5650.8651.361.54
21125317-112531749.45350.24
31177817-117781751.76052.55
41149305-114930550.50751.28
51154457-115445750.73451.51
61159533-115953350.95751.75
60min11262748-126274855.49355.780.7656.5656.840.75
21266928-126692855.67656.74
31283810-128381056.41857.49
41277052-127705256.12157.17
51257460-125746055.26056.31
61267963-126796355.72256.80
极限11328077-132807758.36358.911.5059.7460.291.47
21307565-130756557.46258.84
31351924-135192459.41160.80
41346091-134609159.15560.52
51345008-134500859.10860.47
61364886-136488659.98161.37
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