氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181408591398351412491400991397401403560.48
214.241409541400751405140.45
单位质量响应值RSD%判断
9898.179867.560.22数据可信
供试品溶液-2025011111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%
5min121424-2142414.05517.5333.7014.0517.5333.70
238113-3811325.00325.00
313230-132308.6798.68
424975-2497516.38416.38
534499-3449922.63222.63
628073-2807318.41718.42
10min159798-5979839.22949.7519.6439.3949.9419.68
286083-8608356.47356.75
354589-5458935.81235.91
484340-8434055.32955.51
590171-9017159.15559.41
679990-7999052.47652.68
15min1101094-10109466.32071.898.3866.9172.648.52
2116114-11611476.17477.08
396688-9668863.43063.92
4114726-11472675.26376.06
5120211-12021178.86279.77
6108667-10866771.28972.08
20min1125718-12571882.47483.504.1783.8085.044.30
2125902-12590282.59584.35
3120550-12055079.08480.28
4131413-13141386.21187.84
5135443-13544388.85490.64
6124635-12463581.76483.34
30min1138399-13839990.79492.763.9793.0495.234.04
2138472-13847290.84193.51
3138455-13845590.83092.91
4141284-14128492.68695.28
5152618-152618100.122102.89
6139133-13913391.27593.76
45min1150529-15052998.75197.493.07102.01100.993.09
2145755-14575595.61999.30
3146684-14668496.22999.32
4146631-14663196.19499.81
5157030-157030103.016106.90
6144984-14498495.11398.62
60min1152762-152762100.21697.933.21104.57102.523.05
2146009-14600995.786100.53
3152952-152952100.341104.50
4146042-14604295.808100.50
5154760-154760101.527106.56
6143163-14316393.91998.48
极限1157448-157448103.29096.188.19108.76101.867.74
2148540-14854097.446103.25
3152481-152481100.032105.30
4127316-12731683.52389.28
5156753-156753102.834108.99
6137120-13712089.95495.56
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181368595136848213698921368898136918913690110.05
210.191363564136563513646000.11
单位质量响应值RSD%判断
134480.45133915.600.30数据可信
供试品溶液-2025011111批-厄贝沙坦-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%
5min1229246-22924615.37421.1436.9015.3721.1436.90
2471646-47164631.63131.63
3141525-1415259.4919.49
4318549-31854921.36421.36
5382190-38219025.63225.63
6348436-34843623.36823.37
10min1654278-65427843.87959.4723.3944.0559.7023.42
21037170-103717069.55869.91
3587362-58736239.39239.50
41025736-102573668.79169.03
51006597-100659767.50867.79
61008921-100892167.66467.92
15min11128893-112889375.71082.448.4276.3783.348.61
21301938-130193887.31588.44
31068925-106892571.68872.23
41312589-131258988.02989.03
51284790-128479086.16587.20
61278376-127837685.73586.75
20min11314052-131405288.12791.454.3189.6393.264.53
21375438-137543892.24494.34
31272831-127283185.36386.70
41429089-142908995.84297.82
51388053-138805393.09095.08
61402259-140225994.04396.01
30min11382854-138285492.74296.993.0595.2299.823.30
21466459-146645998.349101.47
31397315-139731593.71196.00
41477185-147718599.068102.11
51481925-148192599.386102.41
61471559-147155998.691101.70
45min11453613-145361397.48798.851.90101.00102.762.16
21478283-147828399.142103.35
31432602-143260296.07899.41
41511216-1511216101.350105.50
51492764-1492764100.113104.24
61475270-147527098.940103.05
60min11468789-146878998.50599.130.88103.10104.131.03
21485650-148565099.636104.95
31476872-147687299.047103.44
41498890-1498890100.524105.80
51461909-146190998.043103.29
61476119-147611998.996104.20
极限11493318-1493318100.15098.501.69105.84104.611.45
21476276-147627699.007105.43
31478074-147807499.128104.63
41440474-144047496.606102.99
51488932-148893299.856106.19
61435382-143538296.264102.57
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181392291399891395761391781397321395410.25
214.241404891398171401530.34
单位质量响应值RSD%判断
9840.699842.210.02数据可信
供试品溶液-2025011211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%
5min118537-1853712.21220.5526.0812.2120.5526.08
230984-3098420.41220.41
328427-2842718.72718.73
432407-3240721.34921.35
543765-4376528.83228.83
633025-3302521.75621.76
10min169686-6968645.90855.3010.6146.0455.5310.67
286253-8625356.82257.05
382926-8292654.63154.84
485502-8550256.32856.56
597360-9736064.13964.46
681968-8196853.99954.24
15min1107321-10732170.70276.364.6071.3577.204.67
2112432-11243274.06974.93
3118737-11873778.22279.04
4120795-12079579.57880.44
5120775-12077579.56580.60
6115362-11536275.99976.84
20min1124417-12441781.96485.523.9983.4087.214.04
2128152-12815284.42586.11
3133096-13309687.68289.37
4134844-13484488.83390.58
5134875-13487588.85490.77
6123465-12346581.33783.02
30min1138038-13803890.93893.312.1793.2895.962.25
2140337-14033792.45295.07
3143296-14329694.40197.06
4146380-14638096.43399.17
5142676-14267693.99396.90
6139145-13914591.66794.26
45min1147496-14749697.16896.082.43100.5299.762.38
2145476-14547695.83899.48
3145768-14576896.03099.74
4150285-15028599.006102.81
5146483-14648396.501100.45
6139566-13956691.94495.55
60min1148811-14881198.03596.652.99102.47101.392.91
2146101-14610196.249100.96
3149238-14923898.316103.09
4150877-15087799.396104.30
5146708-14670896.649101.67
6138488-13848891.23495.86
极限1155816-155816102.64998.523.74108.17104.333.58
2146711-14671196.651102.43
3147764-14776497.345103.21
4155080-155080102.165108.17
5150885-15088599.401105.50
6140986-14098692.88098.52
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181359223136129013598141359207135867813596420.08
210.191362807136237013625880.03
单位质量响应值RSD%判断
133560.12133718.160.09数据可信
供试品溶液-2025011211批-厄贝沙坦-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%
5min1224286-22428615.10526.1327.4415.1026.1327.45
2411552-41155227.71627.72
3345872-34587223.29323.29
4362831-36283124.43524.44
5543493-54349336.60236.60
6440282-44028229.65129.65
10min1809550-80955054.52068.1511.1154.6968.4411.18
21076613-107661372.50572.81
3986255-98625566.42066.68
41015650-101565068.40068.67
51139831-113983176.76377.17
61043836-104383670.29870.63
15min11162425-116242578.28486.344.6179.0687.394.72
21298934-129893487.47788.59
31299621-129962187.52488.52
41303614-130361487.79388.82
51318601-131860188.80290.06
61309469-130946988.18789.30
20min11279629-127962986.17792.693.5087.8294.703.62
21389354-138935493.56795.65
31386566-138656693.37995.35
41410092-141009294.96396.97
51399844-139984494.27396.52
61392804-139280493.79995.89
30min11366398-136639892.02197.382.9994.62100.413.07
21485153-1485153100.018103.14
31453765-145376597.905100.91
41481008-148100899.739102.80
51436272-143627296.727100.02
61453018-145301897.854100.99
45min11402260-140226094.43697.922.4598.06102.042.52
21492038-1492038100.482104.72
31450032-145003297.653101.75
41497214-1497214100.831105.00
51442236-144223697.128101.50
61440451-144045197.008101.23
60min11394327-139432793.90297.672.4398.57102.882.50
21482019-148201999.807105.16
31462016-146201698.460103.64
41489868-1489868100.336105.63
51436769-143676996.760102.21
61436892-143689296.768102.07
极限11448052-144805297.52098.221.13103.24104.511.21
21477961-147796199.534106.00
31443060-144306097.184103.46
41480343-148034399.695106.10
51453988-145398897.920104.44
61447057-144705797.453103.83
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181285301281111276841280901279181280670.25
214.241275241266941271090.47
单位质量响应值RSD%判断
9031.528926.190.83数据可信
供试品溶液-2025011111批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min157259-5725941.34734.0929.4941.3534.0929.50
232798-3279823.68323.68
348840-4884035.26735.27
455389-5538939.99640.00
527508-2750819.86419.86
661439-6143944.36544.37
10min1129175-12917593.27775.6915.2793.7476.0715.32
294679-9467968.36868.63
3108140-10814078.08878.48
4104212-10421275.25175.70
581692-8169258.99059.21
6111048-11104880.18880.68
15min1140285-140285101.30095.675.34102.8096.895.48
2132576-13257695.73396.76
3132505-13250595.68296.94
4130805-13080594.45495.73
5120257-12025786.83887.71
6138497-138497100.009101.39
20min1146176-146176105.554101.814.05108.18104.094.13
2143127-143127103.352105.44
3139814-139814100.960103.28
4134149-13414996.86999.20
5134904-13490497.41499.26
6147738-147738106.682109.18
30min1145212-145212104.858105.972.25108.65109.382.21
2151366-151366109.301112.54
3147206-147206106.297109.74
4142231-142231102.705106.11
5145090-145090104.769107.69
6149411-149411107.890111.57
45min1147452-147452106.475107.081.85111.43111.671.78
2147615-147615106.593111.04
3151426-151426109.345113.97
4143629-143629103.714108.26
5149851-149851108.207112.29
6149738-149738108.126113.01
60min1144204-144204104.130107.524.15110.27113.303.97
2148202-148202107.017112.65
3149442-149442107.912113.75
4160130-160130115.630121.33
5142475-142475102.881108.17
6148928-148928107.541113.62
极限1146209-146209105.578107.161.95112.88114.141.96
2148309-148309107.094113.92
3152172-152172109.883116.92
4145967-145967105.403112.39
5146016-146016105.438111.87
6151744-151744109.574116.85
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181356942135136513554321356152135686213553510.18
210.191347612134693413472730.04
单位质量响应值RSD%判断
133138.61132215.210.50数据可信
供试品溶液-2025011111批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1333859-33385922.64717.6733.3722.6517.6733.37
2169591-16959111.50411.50
3255238-25523817.31417.31
4305767-30576720.74220.74
5144879-1448799.8289.83
6353589-35358923.98623.99
10min1876384-87638459.44945.6418.8359.7045.8418.88
2587813-58781339.87440.00
3661974-66197444.90545.10
4687046-68704646.60646.84
5502755-50275534.10434.21
6721207-72120748.92349.19
15min11084076-108407673.53866.327.9774.4567.028.11
2947038-94703864.24264.81
3930402-93040263.11463.80
41005182-100518268.18668.93
5867326-86732658.83559.32
61031622-103162269.98070.79
20min11218448-121844882.65377.265.6584.3878.705.78
21132414-113241476.81778.10
31078105-107810573.13374.53
41137624-113762477.17078.68
51061076-106107671.97873.12
61206384-120638481.83583.42
30min11318485-131848589.43988.992.6892.0991.292.76
21349227-134922791.52593.66
31270720-127072086.19988.40
41338106-133810690.77093.13
51266442-126644285.90987.85
61328101-132810190.09192.59
45min11431359-143135997.09696.011.57100.7499.301.65
21426778-142677896.78599.94
31381851-138185193.73896.90
41442345-144234597.841101.21
51404300-140430095.26098.16
61405402-140540295.33598.83
60min11433562-143356297.24599.114.63101.97103.464.52
21463604-146360499.283103.51
31425694-142569496.712100.92
41593987-1593987108.128112.59
51408566-140856695.55099.50
61440917-144091797.744102.30
极限11460615-146061599.080100.291.63104.88105.751.68
21492541-1492541101.246106.58
31463516-146351699.277104.56
41518028-1518028102.975108.64
51454528-145452898.668103.68
61481423-1481423100.492106.14
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2000
标示量(mg)10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%
114.181278551269491275861258811277671272080.65
214.241264981273631269300.49
单位质量响应值RSD%判断
8970.948913.620.46数据可信
供试品溶液-2025011211批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123287-2328716.88430.9236.6916.8830.9236.69
266784-6678448.42148.42
330256-3025621.93721.94
438045-3804527.58427.58
545812-4581233.21533.22
651656-5165637.45237.45
10min145409-4540932.92365.0234.3133.1165.3634.31
2127162-12716292.19792.74
361829-6182944.82845.07
4104627-10462775.85876.16
590165-9016565.37365.74
6108887-10888778.94779.36
15min1122465-12246588.792100.897.7789.34101.958.03
2152491-152491110.561112.12
3135565-13556598.28999.03
4143272-143272103.877105.03
5133688-13368896.92998.02
6147392-147392106.864108.16
20min1138399-138399100.344103.953.57101.88106.133.89
2151642-151642109.946112.74
3140127-140127101.597103.43
4145360-145360105.391107.69
5139090-139090100.845103.02
6145598-145598105.564108.04
30min1138170-138170100.178104.113.09102.83107.453.41
2151284-151284109.686113.70
3142087-142087103.018105.98
4144268-144268104.599108.07
5141209-141209102.382105.67
6144506-144506104.772108.43
45min1142719-142719103.476106.342.48107.24110.832.82
2151689-151689109.980115.21
3144648-144648104.875108.98
4146825-146825106.453111.09
5143829-143829104.281108.71
6150264-150264108.947113.76
60min1141650-141650102.701105.203.22107.62110.883.48
2152189-152189110.342116.80
3142634-142634103.415108.69
4145104-145104105.206111.03
5140045-140045101.538107.13
6148946-148946107.991114.02
极限1142579-142579103.375107.623.25109.43114.473.51
2152339-152339110.451118.13
3144686-144686104.903111.32
4153112-153112111.012118.00
5145074-145074105.184111.90
6152850-152850110.822118.05
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
110.181346344135069113459341346430134932013477440.16
210.191348292134914113487160.05
单位质量响应值RSD%判断
132391.36132356.820.02数据可信
供试品溶液-2025011211批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124703-1247038.47816.2441.538.4816.2441.53
2408697-40869727.78727.79
3168970-16897011.48811.49
4207266-20726614.09214.09
5248064-24806416.86616.87
6275164-27516418.70818.71
10min1311850-31185021.20241.1235.6921.3041.3035.70
2909264-90926461.82062.13
3421571-42157128.66228.79
4696734-69673447.37047.53
5577087-57708739.23639.42
6712103-71210348.41548.62
15min1950556-95055664.62772.728.8764.9673.369.09
21217871-121787182.80283.80
31035606-103560670.41070.86
41104199-110419975.07475.76
5999598-99959867.96268.59
61109353-110935375.42476.17
20min11193765-119376581.16382.424.4682.2183.864.66
21308681-130868188.97690.89
31190943-119094380.97182.20
41221588-122158883.05584.57
51146114-114611477.92379.30
61212404-121240482.43084.01
30min11341548-134154891.21191.032.5193.1693.402.72
21391429-139142994.60297.51
31305913-130591388.78890.92
41360483-136048392.49894.94
51303396-130339688.61790.86
61330844-133084490.48392.98
45min11469936-146993699.94096.902.00102.90100.281.93
21426614-142661496.994100.95
31394817-139481794.83297.95
41441570-144157098.011101.48
51396383-139638394.93998.17
61422406-142240696.708100.21
60min11478807-1478807100.54397.951.89104.62102.401.91
21455502-145550298.958103.99
31404542-140454295.49499.66
41443982-144398298.175102.73
51414533-141453396.173100.46
61446364-144636498.337102.92
极限11491590-1491590101.412100.672.35106.60106.202.30
21456615-145661599.034105.17
31434157-143415797.507102.74
41530021-1530021104.025109.67
51466884-146688499.732105.08
61504426-1504426102.285107.96
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