达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.821656971656861657671657891656471657170.04
2 12.841654331653291653810.05
单位质量响应值RSD%判断
12926.4412880.140.26数据可信
供试品溶液-25021301批-达格列净-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%
5min1171509-17150985.49484.024.7385.4984.024.73
2167726-16772683.60883.61
3175907-17590787.68687.69
4166551-16655183.02283.02
5154294-15429476.91276.91
6175339-17533987.40387.40
10min1183553-18355391.49792.031.6191.6392.161.61
2188348-18834893.88894.01
3185532-18553292.48492.62
4185008-18500892.22392.35
5179472-17947289.46389.58
6185815-18581592.62592.76
15min1184427-18442791.93392.761.0292.2093.031.03
2189099-18909994.26294.53
3186100-18610092.76793.04
4186170-18617092.80293.06
5183781-18378191.61191.86
6186979-18697993.20593.48
20min1185185-18518592.31192.721.2492.7193.121.24
2189435-18943594.42994.84
3185787-18578792.61193.02
4186758-18675893.09593.50
5182390-18239090.91891.30
6186476-18647692.95493.36
30min1184951-18495192.19492.811.1392.7493.351.14
2189691-18969194.55795.11
3186281-18628192.85793.41
4186764-18676493.09893.64
5183380-18338091.41191.93
6186028-18602892.73193.28
45min1185305-18530592.37192.801.0593.0593.481.05
2189403-18940394.41395.10
3186125-18612592.77993.47
4186953-18695393.19293.87
5183535-18353591.48892.15
6185737-18573792.58693.27
60min1185155-18515592.29692.780.9693.1193.600.97
2189000-18900094.21395.05
3186503-18650392.96893.79
4186828-18682893.13093.95
5183756-18375691.59992.40
6185489-18548992.46293.29
120min1184874-18487492.15692.540.8793.1193.500.87
2188234-18823493.83194.80
3185876-18587692.65593.62
4186622-18662293.02793.99
5183855-18385591.64892.58
6184463-18446391.95192.92
180min1184682-18468292.06092.400.8693.1693.500.87
2187733-18773393.58194.70
3185399-18539992.41893.52
4186631-18663193.03294.13
5183421-18342191.43292.50
6184289-18428991.86492.97
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1183422-18342291.43292.090.8792.6793.330.87
2187323-18732393.37794.63
3184613-18461392.02693.27
4185976-18597692.70593.95
5183299-18329991.37192.58
6183860-18386091.65092.89
360min1183029-18302991.23691.580.8292.6192.950.82
2185944-18594492.68994.08
3183709-18370991.57592.96
4184993-18499392.21593.59
5182154-18215490.80092.15
6182445-18244590.94592.32
480min1181673-18167390.56091.140.8592.0792.650.85
2185244-18524492.34093.87
3182953-18295391.19892.72
4184038-18403891.73993.26
5181555-18155590.50191.98
6181557-18155790.50292.02
600min1180912-18091290.18190.690.7191.8292.340.72
2183904-18390491.67293.35
3181773-18177390.61092.27
4182974-18297491.20992.86
5180491-18049189.97191.59
6181502-18150290.47592.13
720min1180158-18015889.80590.100.8991.5891.880.89
2182963-18296391.20393.01
3181116-18111690.28392.07
4182100-18210090.77392.56
5179064-17906489.26091.01
6179103-17910389.27991.07
极限1179920-17992089.68690.020.7991.6091.940.79
2182883-18288391.16393.11
3179969-17996989.71191.64
4181701-18170190.57492.50
5179048-17904889.25291.14
6179985-17998589.71991.64
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.241072270107410410738301074050107400710736520.08
210.201075212107555210753820.03
单位质量响应值RSD%判断
104848.83105429.610.40数据可信
供试品溶液-25021301批-二甲双胍-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%
5min152424-524244.9865.1721.354.995.1721.38
248761-487614.6384.64
377447-774477.3667.37
452151-521514.9604.96
545417-454174.3204.32
649875-498754.7444.74
10min1114372-11437210.87811.437.9910.8911.447.97
2112616-11261610.71110.72
3114495-11449510.89010.90
4115081-11508110.94610.95
5129162-12916212.28512.29
6135370-13537012.87512.88
15min1163545-16354515.55515.751.2815.5815.781.29
2163068-16306815.51015.53
3165435-16543515.73515.76
4166003-16600315.78915.81
5167213-16721315.90415.93
6168553-16855316.03216.06
20min1203916-20391619.39519.552.9719.4419.602.96
2204018-20401819.40519.45
3215660-21566020.51220.56
4207049-20704919.69319.74
5196807-19680718.71918.77
6205778-20577819.57219.62
30min1269163-26916325.60125.661.4625.6825.741.46
2269998-26999825.68025.76
3272224-27222425.89225.97
4272540-27254025.92226.00
5262268-26226824.94525.02
6272296-27229625.89925.98
45min1347422-34742233.04433.322.3433.1633.442.34
2348785-34878533.17433.29
3364930-36493034.70934.83
4351033-35103333.38833.50
5339895-33989532.32832.44
6349993-34999333.28933.41
60min1411336-41133639.12339.231.0739.2939.401.08
2412424-41242439.22739.39
3416707-41670739.63439.81
4415552-41555239.52439.69
5404459-40445938.46938.63
6414577-41457739.43239.60
120min1594620-59462056.55656.891.0656.7857.121.07
2595091-59509156.60156.82
3600308-60030857.09757.33
4608119-60811957.84058.07
5589927-58992756.11056.33
6600895-60089557.15357.38
180min1723388-72338868.80368.890.6769.1169.200.67
2721975-72197568.66968.98
3727923-72792369.23569.55
4731844-73184469.60869.92
5718124-71812468.30368.61
6722740-72274068.74269.06
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1819529-81952977.94878.120.5778.3678.540.57
2818827-81882777.88178.29
3824330-82433078.40478.83
4829244-82924478.87279.29
5816390-81639077.64978.06
6819771-81977177.97178.39
360min1953900-95390090.72890.530.5991.2691.060.59
2947229-94722990.09490.62
3953230-95323090.66491.20
4961288-96128891.43191.97
5946229-94622989.99890.52
6949244-94924490.28590.82
480min11032804-103280498.23398.040.5898.9098.710.58
21026925-102692597.67498.34
31030726-103072698.03598.71
41041476-104147699.05899.73
51025291-102529197.51898.18
61027411-102741197.72098.39
600min11077879-1077879102.520102.280.61103.33103.100.61
21069549-1069549101.728102.54
31072734-1072734102.031102.85
41085923-1085923103.285104.11
51068351-1068351101.614102.42
61077938-1077938102.526103.34
720min11098712-1098712104.501104.080.61105.47105.040.61
21089814-1089814103.655104.62
31092050-1092050103.868104.84
41105373-1105373105.135106.11
51087496-1087496103.435104.39
61091953-1091953103.859104.83
极限11099734-1099734104.599104.120.60105.72105.240.60
21090584-1090584103.728104.85
31089763-1089763103.650104.78
41104462-1104462105.048106.18
51087530-1087530103.438104.55
61096049-1096049104.248105.37
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.821652151651431651331651831653581652060.06
2 12.841653081655041654060.09
单位质量响应值RSD%判断
12886.5812882.090.03数据可信
供试品溶液-25021302批-达格列净-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%
5min1164486-16448682.11382.314.2082.1182.314.19
2151334-15133475.54875.55
3170034-17003484.88384.88
4167007-16700783.37283.37
5167377-16737783.55683.56
6169091-16909184.41284.41
10min1181557-18155790.63591.962.1490.7692.092.13
2180462-18046290.08990.20
3182584-18258491.14891.28
4191380-19138095.53995.66
5185545-18554592.62692.75
6183767-18376791.73891.87
15min1183839-18383991.77492.851.9892.0393.101.98
2183197-18319791.45491.70
3183842-18384291.77692.04
4192669-19266996.18296.45
5187833-18783393.76894.03
6184525-18452592.11792.38
20min1184350-18435092.03093.351.8592.4393.751.85
2185670-18567092.68893.07
3184917-18491792.31392.71
4193633-19363396.66497.08
5187709-18770993.70694.11
6185661-18566192.68493.09
30min1184836-18483692.27293.491.6792.8194.041.67
2186546-18654693.12693.65
3185247-18524792.47793.02
4193353-19335396.52497.08
5187500-18750093.60294.15
6186208-18620892.95793.50
45min1185132-18513292.42093.541.8393.0994.221.83
2187014-18701493.35994.02
3184751-18475192.23092.91
4193937-19393796.81597.52
5187777-18777793.74094.43
6185647-18564792.67793.36
60min1185014-18501492.36193.381.6993.1794.201.69
2186869-18686993.28794.09
3184625-18462592.16792.98
4193242-19324296.46997.32
5186590-18659093.14893.97
6186035-18603592.87193.69
120min1184726-18472692.21793.301.6893.1794.261.68
2186620-18662093.16394.11
3184222-18422291.96692.92
4192906-19290696.30197.29
5187022-18702293.36394.33
6185826-18582692.76693.73
180min1184073-18407391.89193.241.5492.9894.341.54
2186333-18633393.01994.10
3187527-18752793.61694.71
4192124-19212495.91097.05
5185446-18544692.57793.68
6185143-18514392.42593.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1183421-18342191.56692.631.7692.7993.871.76
2185259-18525992.48393.71
3183070-18307091.39192.62
4191900-19190095.79997.08
5185462-18546292.58593.83
6184164-18416491.93793.17
360min1182025-18202590.86992.271.6292.2393.651.62
2184678-18467892.19393.56
3182810-18281091.26192.63
4190527-19052795.11396.54
5184534-18453492.12193.51
6184391-18439192.05093.42
480min1181119-18111990.41791.731.7091.9293.241.69
2183220-18322091.46592.97
3181517-18151790.61592.12
4189732-18973294.71696.28
5183703-18370391.70793.23
6183156-18315691.43392.95
600min1180151-18015189.93391.372.2291.5793.022.20
2182148-18214890.93092.57
3180066-18006689.89191.53
4190973-19097395.33697.04
5182604-18260491.15892.82
6182206-18220690.95992.61
720min1179309-17930989.51390.951.8091.2892.741.79
2181508-18150890.61192.38
3178860-17886089.28991.07
4186587-18658793.14695.00
5185804-18580492.75594.55
6181084-18108490.39992.19
极限1179040-17904089.37990.671.7891.2892.601.77
2180546-18054690.13192.04
3178461-17846189.09091.00
4187098-18709893.40195.39
5181019-18101990.36792.30
6183557-18355791.63493.56
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000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%
110.241074424107420410730811073574107375310738070.05
210.201072920107287710728980.01
单位质量响应值RSD%判断
104863.96105186.080.22数据可信
供试品溶液-25021302批-二甲双胍-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%
5min157759-577595.5005.4716.675.505.4716.71
249460-494604.7094.71
355535-555355.2885.29
454300-543005.1705.17
551396-513964.8944.89
675986-759867.2357.24
10min1113881-11388110.84311.072.4710.8511.082.46
2113068-11306810.76610.77
3120114-12011411.43711.44
4114882-11488210.93910.95
5116652-11665211.10711.11
6119138-11913811.34411.35
15min1196936-19693618.75116.747.1018.7816.767.09
2183459-18345917.46817.49
3172965-17296516.46916.49
4164124-16412415.62715.65
5172414-17241416.41716.44
6165008-16500815.71115.74
20min1205647-20564719.58119.903.0519.6319.953.04
2203841-20384119.40919.46
3207646-20764619.77119.82
4221588-22158821.09921.15
5208540-20854019.85619.90
6206999-20699919.71019.76
30min1281429-28142926.79626.362.2526.8826.442.24
2269145-26914525.62725.71
3271418-27141825.84325.92
4280602-28060226.71826.80
5273682-27368226.05926.14
6284505-28450527.08927.17
45min1348987-34898733.22933.140.6533.3533.260.64
2346879-34687933.02833.15
3346541-34654132.99633.11
4348424-34842433.17533.29
5351790-35179033.49633.61
6345509-34550932.89833.02
60min1412722-41272239.29839.371.2839.4739.541.28
2409788-40978839.01839.18
3423029-42302940.27940.45
4411311-41131139.16339.33
5415673-41567339.57939.75
6408612-40861238.90639.08
120min1592962-59296256.45956.520.7456.6956.750.74
2589902-58990256.16856.39
3597431-59743156.88557.11
4596044-59604456.75356.98
5598157-59815756.95457.18
6587310-58731055.92156.15
180min1719919-71991968.54868.911.2568.8669.221.25
2715141-71514168.09368.40
3735384-73538470.02070.33
4731437-73143769.64469.96
5727274-72727469.24869.56
6713198-71319867.90868.22
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1815106-81510677.61177.620.9778.0378.040.97
2809197-80919777.04877.46
3810838-81083877.20477.62
4824029-82402978.46078.88
5825346-82534678.58679.00
6806687-80668776.80977.22
360min1944053-94405389.88990.090.8490.4290.620.84
2938625-93862589.37289.90
3943420-94342089.82890.36
4952698-95269890.71291.25
5958660-95866091.27991.81
6939339-93933989.44089.97
480min11021962-102196297.30797.700.9397.9898.360.93
21016449-101644996.78297.44
31023314-102331497.43598.10
41035246-103524698.57299.24
51040352-104035299.05899.73
61019059-101905997.03097.69
600min11066641-1066641101.561101.841.02102.38102.661.02
21059045-1059045100.838101.64
31064133-1064133101.322102.14
41083412-1083412103.158103.98
51083037-1083037103.122103.94
61061244-1061244101.047101.86
720min11086511-1086511103.453103.911.34104.42104.881.34
21080758-1080758102.905103.86
31085846-1085846103.390104.36
41096765-1096765104.429105.40
51118518-1118518106.500107.47
61079735-1079735102.808103.77
极限11086235-1086235103.427103.750.88104.55104.870.88
21077967-1077967102.639103.75
31085841-1085841103.389104.51
41099426-1099426104.683105.81
51103015-1103015105.024106.16
61085078-1085078103.316104.43
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