达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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1000
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%
112.452002862007412005692004802004222005000.09
212.582015392014272014830.04
单位质量响应值RSD%判断
16104.4216016.140.39数据可信
供试品溶液-WA3063批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min110662-106625.3387.1418.965.347.1418.96
218256-182569.1399.14
313862-138626.9406.94
412569-125696.2926.29
516357-163578.1898.19
613830-138306.9246.92
5min1130718-13071865.44065.118.0465.4465.118.04
2136423-13642368.29668.30
3116929-11692958.53758.54
4120423-12042360.28660.29
5130271-13027165.21665.22
6145543-14554372.86172.86
10min1182027-18202791.12688.633.3391.1388.633.33
2178161-17816189.19189.19
3171326-17132685.76985.77
4174828-17482887.52287.52
5170598-17059885.40485.40
6185285-18528592.75792.76
15min1189925-18992595.08092.233.0095.0892.233.00
2184270-18427092.24992.25
3178560-17856089.39089.39
4183410-18341091.81891.82
5178002-17800289.11189.11
6191177-19117795.70795.71
20min1192821-19282196.53093.443.0696.5393.443.06
2186874-18687493.55293.55
3181180-18118090.70290.70
4185517-18551792.87392.87
5179933-17993390.07890.08
6193560-19356096.90096.90
30min1195656-19565697.94994.893.0097.9594.903.00
2190599-19059995.41795.42
3184171-18417192.19992.20
4187676-18767693.95493.95
5182893-18289391.55991.56
6196333-19633398.28898.29
极限1198780-19878099.51399.600.8999.5199.600.89
2197448-19744898.84698.85
3199405-19940599.82699.83
4200602-200602100.425100.42
5196486-19648698.36498.36
6200981-200981100.615100.61
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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1000
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%
112.452013182013962013102013452012652013270.03
212.582017712015912016810.07
单位质量响应值RSD%判断
16170.8416031.880.62数据可信
供试品溶液-WA3063批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min127825-2782513.8949.8843.6913.899.8843.70
230798-3079815.37915.38
310775-107755.3805.38
415920-159207.9507.95
510676-106765.3315.33
622773-2277311.37211.37
5min1134610-13461067.21759.3419.4267.2259.3419.42
2142891-14289171.35271.35
389820-8982044.85144.85
4101982-10198250.92450.92
5103283-10328351.57451.57
6140419-14041970.11870.12
10min1164360-16436082.07377.989.6182.0777.989.60
2168267-16826784.02384.02
3132131-13213165.97965.98
4158131-15813178.96278.96
5144268-14426872.04072.04
6169852-16985284.81584.81
15min1176367-17636788.06883.438.3288.0783.448.32
2177760-17776088.76488.76
3144700-14470072.25572.26
4170680-17068085.22885.23
5155295-15529577.54677.55
6177717-17771788.74288.74
20min1182086-18208690.92486.247.4690.9286.247.46
2183246-18324691.50391.50
3153072-15307276.43676.44
4176261-17626188.01588.02
5160189-16018979.99079.99
6181396-18139690.57990.58
30min1187497-18749793.62689.066.4293.6389.066.42
2187645-18764593.70093.70
3161964-16196480.87680.88
4181538-18153890.65090.65
5165899-16589982.84182.84
6185530-18553092.64492.64
极限1197267-19726798.50498.251.2598.5098.251.25
2196289-19628998.01698.02
3198719-19871999.23099.23
4199555-19955599.64799.65
5192594-19259496.17196.17
6196088-19608897.91697.92
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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1000
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%
112.452011362012742011302008742010872011000.08
212.582030942035692033320.17
单位质量响应值RSD%判断
16152.6116163.120.05数据可信
供试品溶液-WA3063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%
2min130057-3005714.9569.2936.4514.969.2936.44
213606-136066.7706.77
316318-163188.1208.12
411346-113465.6465.65
522735-2273511.31311.31
617971-179718.9428.94
5min1152304-15230475.78561.3915.1275.7961.3915.13
2101324-10132450.41850.42
3131735-13173565.55065.55
4105650-10565052.57052.57
5128443-12844363.91263.91
6120782-12078260.10060.10
10min1176423-17642387.78680.517.4387.7980.517.43
2144887-14488772.09472.09
3173341-17334186.25386.25
4152549-15254975.90775.91
5162785-16278581.00081.00
6160783-16078380.00480.00
15min1185128-18512892.11885.616.3192.1285.616.31
2157578-15757878.40978.41
3183388-18338891.25291.25
4163226-16322681.22081.22
5170849-17084985.01385.01
6172169-17216985.67085.67
20min1190320-19032094.70187.816.2594.7087.816.25
2161842-16184280.53180.53
3187547-18754793.32293.32
4167731-16773183.46183.46
5174672-17467286.91586.92
6176691-17669187.92087.92
30min1194955-19495597.00890.016.0897.0190.016.08
2165933-16593382.56782.57
3191053-19105395.06695.07
4172282-17228285.72685.73
5179168-17916889.15289.15
6181925-18192590.52490.52
极限1201114-201114100.07299.611.64100.0799.611.64
2200232-20023299.63499.63
3203083-203083101.052101.05
4199563-19956399.30199.30
5194169-19416996.61796.62
6202970-202970100.996101.00
达格列净片项目信息
介质体积(ml)1000取样体积(ml)0补液体积(ml)0
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1000
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%
112.452009372012042011352011652014292011740.09
212.582025242021102023170.15
单位质量响应值RSD%判断
16158.5516082.430.34数据可信
供试品溶液-WA3063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%
2min117861-178618.9087.9320.478.917.9320.50
212099-120996.0346.03
318337-183379.1469.15
419383-193839.6679.67
511833-118335.9025.90
615873-158737.9177.92
5min1134460-13446067.06159.5911.7567.0659.5911.75
2107163-10716353.44753.45
3139006-13900669.32969.33
4113516-11351656.61656.62
5105851-10585152.79352.79
6116898-11689858.30358.30
10min1168216-16821683.89780.416.1883.9080.416.18
2160016-16001679.80779.81
3177117-17711788.33788.34
4153307-15330776.46176.46
5150159-15015974.89174.89
6158564-15856479.08379.08
15min1175716-17571687.63884.455.1887.6484.455.18
2166016-16601682.80082.80
3183781-18378191.66091.66
4161270-16127080.43380.43
5161998-16199880.79680.80
6167118-16711883.35083.35
20min1180129-18012989.83986.125.2989.8486.125.29
2168108-16810883.84383.84
3187241-18724193.38693.39
4163319-16331981.45581.45
5166691-16669183.13783.14
6170550-17055085.06185.06
30min1185259-18525992.39787.975.3492.4087.975.34
2170686-17068685.12985.13
3190305-19030594.91494.91
4166096-16609682.84082.84
5170811-17081185.19185.19
6175155-17515587.35887.36
极限1201116-201116100.30698.630.98100.3198.630.99
2197342-19734298.42498.42
3198657-19865799.08099.08
4196391-19639197.94997.95
5195637-19563797.57397.57
6197401-19740198.45398.45
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