盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088495868538998543878513258510878520570.24
210.128485598517058501320.27
单位质量响应值RSD%判断
84529.4684005.140.44数据可信
供试品溶液-X3462批-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%
5min1841153-84115399.02297.781.1299.0297.781.12
2816686-81668696.14296.14
3827875-82787597.45997.46
4830842-83084297.80897.81
5826766-82676697.32897.33
6840514-84051498.94798.95
10min1835287-83528798.33197.550.9198.6397.840.92
2817390-81739096.22596.51
3829337-82933797.63197.92
4829181-82918197.61397.91
5823045-82304596.89097.18
6837660-83766098.61198.91
15min1834627-83462798.25497.220.9898.8597.810.98
2813522-81352295.76996.35
3823293-82329396.92097.50
4827832-82783297.45498.04
5821762-82176296.73997.32
6834165-83416598.19998.79
20min1829525-82952597.65396.860.8798.5497.740.87
2811241-81124195.50196.37
3822654-82265496.84497.72
4824245-82424597.03297.91
5818902-81890296.40397.28
6830352-83035297.75198.64
30min1831640-83164097.90296.950.9499.0898.120.94
2812036-81203695.59496.75
3822419-82241996.81797.98
4824439-82443997.05498.22
5818704-81870496.37997.54
6832001-83200197.94599.13
45min1827209-82720997.38196.470.9298.8597.930.92
2808211-80821195.14496.58
3818904-81890496.40397.86
4820644-82064496.60898.07
5814168-81416895.84597.30
6827690-82769097.43798.91
60min1824528-82452897.06596.120.9498.8397.860.94
2804705-80470594.73196.45
3816544-81654496.12597.87
4817467-81746796.23497.98
5811435-81143595.52497.26
6824182-82418297.02498.79
极限1820657-82065796.60995.680.9098.6797.720.90
2801188-80118894.31796.32
3812082-81208295.60097.63
4813498-81349895.76697.81
5809247-80924795.26697.29
6820100-82010096.54498.60
盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088407798417598415628416588414918414500.05
210.128421458385068403260.31
单位质量响应值RSD%判断
83477.1883036.170.38数据可信
供试品溶液-X3462批-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%
5min1825960-82596098.41397.890.7098.4197.890.70
2824602-82460298.25298.25
3811241-81124196.66096.66
4821361-82136197.86697.87
5819847-81984797.68597.69
6826418-82641898.46898.47
10min1831759-83175999.10497.650.9699.4097.950.96
2822178-82217897.96398.26
3807926-80792696.26596.55
4818237-81823797.49397.79
5816518-81651897.28897.58
6820874-82087497.80898.10
15min1828333-82833398.69697.351.0099.2997.940.99
2823105-82310598.07398.66
3805623-80562395.99096.57
4815362-81536297.15197.74
5811665-81166596.71097.30
6818188-81818897.48798.08
20min1825588-82558898.36996.941.0399.2697.821.03
2819151-81915197.60298.49
3801704-80170495.52396.39
4810993-81099396.63097.51
5808716-80871696.35997.23
6815666-81566697.18798.07
30min1823955-82395598.17597.080.9599.3698.250.95
2820344-82034497.74498.92
3801957-80195795.55496.71
4813890-81389096.97598.14
5811169-81116996.65197.82
6817246-81724697.37598.55
45min1821330-82133097.86296.751.0899.3498.211.08
2820891-82089197.81099.28
3799545-79954595.26696.71
4808271-80827196.30697.76
5806109-80610996.04897.50
6815788-81578897.20298.67
60min1818395-81839597.51296.281.1699.2898.041.16
2818832-81883297.56499.33
3795390-79539094.77196.50
4804785-80478595.89097.64
5801662-80166295.51897.26
6809491-80949196.45198.21
极限1815757-81575797.19895.961.1599.2698.001.15
2816775-81677597.31999.37
3793322-79332294.52596.53
4802702-80270295.64297.68
5799429-79942995.25297.28
6804355-80435595.83997.89
盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088489868486738490008489138494528490050.04
210.128511388518108514740.06
单位质量响应值RSD%判断
84226.6984137.750.08数据可信
供试品溶液-X3462批-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%
5min1860639-860639101.41798.922.36101.4298.922.36
2841359-84135999.14599.15
3822244-82224496.89396.89
4865072-865072101.940101.94
5818829-81882996.49196.49
6828535-82853597.63497.63
10min1866448-866448102.10299.792.03102.41100.092.03
2842058-84205899.22899.53
3834596-83459698.34898.64
4870352-870352102.562102.87
5831195-83119597.94898.24
6836217-83621798.54098.83
15min1863549-863549101.76099.512.04102.37100.102.04
2842401-84240199.26899.86
3831748-83174898.01398.60
4867825-867825102.264102.88
5828534-82853497.63498.22
6832426-83242698.09398.68
20min1860114-860114101.35699.191.93102.27100.081.93
2839863-83986398.96999.86
3829918-82991897.79798.68
4863451-863451101.749102.67
5826530-82653097.39898.27
6830521-83052197.86898.75
30min1856574-856574100.93898.751.95102.1699.951.96
2836218-83621898.54099.73
3826621-82662197.40998.58
4859833-859833101.322102.55
5821696-82169696.82898.00
6827310-82731097.49098.67
45min1853746-853746100.60598.281.94102.1399.771.94
2831577-83157797.99399.48
3823237-82323797.01098.48
4854391-854391100.681102.21
5818381-81838196.43897.90
6822805-82280596.95998.43
60min1848147-84814799.94597.831.87101.7799.611.87
2826847-82684797.43599.21
3818363-81836396.43698.19
4851002-851002100.282102.11
5815883-81588396.14397.89
6821043-82104396.75198.51
极限1845392-84539299.62197.481.97101.7599.561.97
2824991-82499197.21799.29
3814384-81438495.96798.01
4849252-849252100.076102.21
5811486-81148695.62597.66
6817997-81799796.39298.44
盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088497958492218495268501518494938496370.05
210.128530528523598527060.06
单位质量响应值RSD%判断
84289.3884259.490.03数据可信
供试品溶液-X3462批-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%
5min1827366-82736697.39098.251.0397.3998.261.03
2846122-84612299.59899.60
3826810-82681097.32497.32
4828904-82890497.57197.57
5844019-84401999.35099.35
6835061-83506198.29698.30
10min1835553-83555398.35499.071.3098.6599.361.30
2848407-84840799.867100.17
3830283-83028397.73398.03
4835216-83521698.31498.61
5860044-860044101.236101.53
6840212-84021298.90299.20
15min1832347-83234797.97698.791.3398.5699.381.32
2846345-84634599.624100.22
3828156-82815697.48398.07
4831792-83179297.91198.50
5857632-857632100.952101.55
6839118-83911898.77399.36
20min1829626-82962697.65698.291.3098.5499.181.30
2844340-84434099.388100.29
3824439-82443997.04597.92
4827253-82725397.37798.26
5851930-851930100.281101.19
6832444-83244497.98898.88
30min1823198-82319896.89997.901.3798.0799.081.37
2842299-84229999.148100.34
3821851-82185196.74197.91
4823350-82335096.91798.09
5848825-84882599.916101.12
6830460-83046097.75498.94
45min1821768-82176896.73197.571.3898.2099.041.38
2840636-84063698.952100.44
3816136-81613696.06897.53
4822053-82205396.76498.23
5844812-84481299.443100.95
6827770-82777097.43798.91
60min1817397-81739796.21696.921.4997.9798.691.49
2836572-83657298.473100.26
3810579-81057995.41497.16
4816134-81613496.06897.82
5840727-84072798.963100.77
6818906-81890696.39498.16
极限1813112-81311295.71296.541.5697.7698.611.56
2834274-83427498.203100.29
3804502-80450294.69896.73
4811929-81192995.57397.62
5836090-83609098.417100.52
6821197-82119796.66498.72
盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088421318411418419548421778423918419590.06
210.128414708391648403170.20
单位质量响应值RSD%判断
83527.6883035.280.42数据可信
供试品溶液-X3462批-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%
5min1823162-82316298.05199.001.5198.0599.001.51
2834576-83457699.41199.41
3831504-83150499.04599.04
4834644-83464499.41999.42
5850032-850032101.252101.25
6812722-81272296.80896.81
10min1823356-82335698.07499.111.7298.3799.401.72
2835400-83540099.50999.81
3827890-82789098.61498.91
4837397-83739799.747100.04
5855038-855038101.848102.15
6813010-81301096.84297.13
15min1820951-82095197.78898.701.7098.3899.301.69
2834099-83409999.35499.95
3825849-82584998.37198.96
4829198-82919898.77099.37
5851782-851782101.460102.07
6809967-80996796.47997.06
20min1817082-81708297.32798.361.6798.2199.251.67
2830098-83009898.87799.77
3821579-82157997.86398.75
4828931-82893198.73899.63
5848645-848645101.086102.00
6808416-80841696.29597.16
30min1813337-81333796.88198.061.7098.0599.241.70
2828746-82874698.71699.91
3820450-82045097.72898.91
4826547-82654798.45499.64
5845381-845381100.698101.91
6804796-80479695.86397.02
45min1812082-81208296.73197.691.6498.2099.171.64
2825948-82594898.38399.87
3815130-81513097.09498.57
4824904-82490498.25999.74
5840638-840638100.133101.65
6801948-80194895.52496.97
60min1808073-80807396.25497.351.7398.0199.121.73
2822634-82263497.98899.77
3813918-81391896.95098.72
4821178-82117897.81599.59
5839600-839600100.009101.83
6798311-79831195.09196.82
极限1803708-80370895.73496.941.7597.7899.011.75
2819290-81929097.59099.67
3808965-80896596.36098.42
4817321-81732197.35599.43
5837187-83718799.722101.84
6796605-79660594.88896.91
盐酸贝那普利片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号100768-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.2对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.088398418389228381208388858386868388910.08
210.128469508465118467300.04
单位质量响应值RSD%判断
83223.3183668.970.38数据可信
供试品溶液-X3462批-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%
5min1805263-80526395.73097.891.7795.7397.891.77
2829905-82990598.65998.66
3843982-843982100.333100.33
4832816-83281699.00599.01
5814345-81434596.80996.81
6814138-81413896.78596.78
10min1842255-842255100.12798.771.58100.4199.061.57
2833633-83363399.10299.40
3847027-847027100.695101.00
4830441-83044198.72399.02
5815739-81573996.97597.27
6815828-81582896.98697.28
15min1841226-841226100.00598.531.65100.5999.121.65
2832514-83251498.96999.56
3845265-845265100.485101.09
4827375-82737598.35898.95
5813132-81313296.66597.25
6813176-81317696.67097.25
20min1841733-841733100.06598.181.73100.9599.061.72
2828193-82819398.45699.35
3841241-841241100.007100.91
4824160-82416097.97698.86
5808419-80841996.10596.98
6811299-81129996.44797.32
30min1842395-842395100.14497.831.83101.3399.011.82
2824311-82431197.99499.18
3837007-83700799.503100.71
4820789-82078997.57598.76
5805924-80592495.80896.97
6807078-80707895.94597.11
45min1837759-83775999.59397.461.80101.0898.941.79
2822829-82282997.81899.30
3834764-83476499.237100.74
4815824-81582496.98598.46
5803824-80382495.55997.01
6803975-80397595.57697.02
60min1839845-83984599.84197.181.96101.6398.941.95
2817153-81715397.14398.92
3831757-83175798.879100.68
4814206-81420696.79398.56
5800024-80002495.10796.84
6801626-80162695.29797.03
极限1841026-84102699.98196.822.12102.0798.882.11
2813882-81388296.75498.82
3827529-82752998.377100.47
4809291-80929196.20898.26
5799221-79922195.01197.03
6795749-79574994.59996.62
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