非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103071493072593076253073813065773071980.13
211.193091193090623090900.02
单位质量响应值RSD%判断
27675.5027621.980.14数据可信
供试品溶液-6020401批-恩格列净-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%
5min1232949-23294974.539102.1636.8574.54102.1636.85
2555892-555892177.874177.87
3288550-28855092.33092.33
4282703-28270390.45990.46
5277967-27796788.94488.94
6277501-27750188.79488.79
10min1295497-29549794.553115.3435.0795.38116.4735.09
2617997-617997197.746199.72
3318499-318499101.913102.94
4308868-30886898.83199.84
5312202-31220299.898100.89
6309622-30962299.072100.06
15min1310522-31052299.360116.9734.57101.24119.3834.60
2623376-623376199.467203.64
3320820-320820102.656104.81
4310778-31077899.442101.55
5314893-314893100.759102.86
6312909-312909100.124102.21
20min1311928-31192899.810117.0034.40102.79120.7234.43
2622245-622245199.105205.50
3321844-321844102.983106.28
4310947-31094799.496102.70
5314641-314641100.678103.90
6312325-31232599.937103.14
30min1311975-31197599.825117.1334.69103.92122.1534.71
2625099-625099200.018208.62
3322192-322192103.095107.54
4310750-31075099.433103.75
5315320-315320100.896105.23
6311035-31103599.525103.83
45min1312258-31225899.916117.1834.44105.12123.5034.47
2623502-623502199.507210.33
3322740-322740103.270108.86
4311520-31152099.680105.10
5315832-315832101.060106.52
6311469-31146999.663105.08
60min1310994-31099499.511116.9034.60105.82124.5234.61
2623132-623132199.389212.43
3322216-322216103.102109.84
4310020-31002099.200105.73
5314788-314788100.725107.31
6310880-31088099.475106.00
极限1311691-31169199.734116.7934.57107.15125.7134.59
2622378-622378199.148214.40
3321531-321531102.883110.76
4309698-30969899.097106.73
5315185-315185100.852108.55
6309488-30948899.030106.66
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号250201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%
111.043896583894493901693893653890403895360.11
211.043933223929133931180.08
单位质量响应值RSD%判断
35284.0635608.510.65数据可信
供试品溶液-6020401批-非奈利酮-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%
5min164514-6451416.38118.6252.1516.3818.6252.15
2-0.0000.00
391732-9173223.29223.29
4103207-10320726.20526.21
585267-8526721.65021.65
695251-9525124.18524.19
10min1143672-14367236.48040.2651.2736.6640.4751.27
2-0.0000.00
3210060-21006053.33653.60
4204727-20472751.98252.27
5193866-19386649.22549.47
6199038-19903850.53850.81
15min1216946-21694655.08552.7249.6555.6753.3849.66
2-0.0000.00
3265601-26560167.43968.29
4255666-25566664.91665.79
5254512-25451264.62365.41
6253116-25311664.26965.10
20min1267320-26732067.87560.3149.1869.0761.5549.19
2-0.0000.00
3298459-29845975.78277.38
4287460-28746072.98974.58
5288017-28801773.13174.64
6283827-28382772.06773.61
30min1316364-31636480.32868.8249.0682.2870.7349.07
2-0.0000.00
3336955-33695585.55688.00
4325548-32554882.66085.06
5327530-32753083.16385.48
6319902-31990281.22783.57
45min1351590-35159089.27275.4249.0492.1278.1049.05
2-0.0000.00
3367731-36773193.37196.76
4356255-35625590.45793.78
5357994-35799490.89894.14
6348748-34874888.55191.80
60min1368215-36821593.49478.6349.0497.3382.1449.04
2-0.0000.00
3381963-38196396.984101.42
4371497-37149794.32798.65
5373301-37330194.78599.04
6363052-36305292.18396.41
极限1376347-37634795.55980.0649.04100.4484.4549.04
2-0.0000.00
3389435-38943598.882104.39
4377510-37751095.854101.23
5380544-38054496.624101.93
6368022-36802293.44598.70
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103082103085803085093086653081823084290.08
211.193084733079423082080.13
单位质量响应值RSD%判断
27786.4027543.160.63数据可信
供试品溶液-1批-恩格列净-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%
5min1279298-27929889.31986.874.2789.3286.874.27
2270827-27082786.61086.61
3268560-26856085.88585.89
4273994-27399487.62387.62
5285592-28559291.33291.33
6251568-25156880.45180.45
10min1315138-315138100.78199.542.09101.77100.502.10
2306858-30685898.13399.10
3318671-318671101.911102.86
4308702-30870298.72399.70
5316282-316282101.147102.16
6301806-30180696.51797.41
15min1312602-31260299.970100.471.69102.08102.541.70
2310306-31030699.236101.29
3321988-321988102.971105.06
4312730-312730100.011102.08
5319116-319116102.053104.19
6308264-30826498.583100.55
20min1312825-312825100.041100.801.60103.26103.991.61
2310832-31083299.404102.56
3322420-322420103.110106.34
4315729-315729100.970104.15
5319698-319698102.239105.51
6309772-30977299.065102.13
30min1312805-312805100.035100.771.64104.37105.081.65
2310712-31071299.365103.63
3322764-322764103.220107.60
4314265-314265100.502104.81
5320048-320048102.351106.76
6310112-31011299.174103.34
45min1312543-31254399.951100.641.58105.40106.071.59
2310648-31064899.345104.71
3322068-322068102.997108.52
4313273-313273100.184105.60
5319640-319640102.221107.77
6310084-31008499.165104.43
60min1312412-31241299.909100.501.61106.47107.051.62
2309231-30923198.892105.36
3321413-321413102.788109.46
4313339-313339100.206106.74
5319437-319437102.156108.84
6309748-30974899.057105.42
极限1310624-31062499.337100.201.66107.00107.861.66
2308236-30823698.574106.14
3320723-320723102.567110.38
4312589-31258999.966107.61
5318614-318614101.892109.71
6309093-30909398.848106.31
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号250201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%
111.043917083919553923333923703918813920490.08
211.043919903914413917160.10
单位质量响应值RSD%判断
35511.6835481.520.07数据可信
供试品溶液-1批-非奈利酮-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%
5min174424-7442418.87020.3214.0918.8720.3214.08
284052-8405221.31121.31
3100149-10014925.39225.39
468371-6837117.33517.34
580773-8077320.48020.48
673082-7308218.53018.53
10min1198470-19847050.32148.254.8950.5348.484.91
2190254-19025448.23848.47
3204362-20436251.81552.10
4184832-18483246.86347.06
5182052-18205246.15846.39
6181902-18190246.12046.33
15min1249895-24989563.36062.043.0864.1362.803.11
2245894-24589462.34563.12
3256185-25618564.95565.81
4241920-24192061.33862.05
5236864-23686460.05660.80
6237412-23741260.19560.91
20min1283379-28337971.84970.592.5673.3272.042.60
2279547-27954770.87872.34
3288656-28865673.18774.77
4277566-27756670.37671.77
5271756-27175668.90270.31
6269619-26961968.36169.75
30min1321057-32105781.40380.661.8583.6782.891.90
2320988-32098881.38583.64
3326172-32617282.69985.09
4317264-31726480.44182.62
5313060-31306079.37581.55
6310155-31015578.63880.79
45min1351569-35156989.13988.411.6092.3191.551.66
2351812-35181289.20092.36
3356230-35623090.32093.63
4347569-34756988.12591.20
5343904-34390487.19590.25
6341199-34119986.50989.53
60min1366384-36638492.89592.291.2197.0696.401.28
2365673-36567392.71596.86
3369652-36965293.72498.04
4364388-36438892.38996.44
5360463-36046391.39495.42
6357463-35746390.63394.61
极限1371054-37105494.07993.781.1499.2898.921.22
2371184-37118494.11299.29
3376371-37637195.427100.78
4369990-36999093.80998.89
5366014-36601492.80197.84
6364521-36452192.42397.41
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103087543085573091363092393087723088920.10
211.193098983095713097340.08
单位质量响应值RSD%判断
27828.1127679.540.38数据可信
供试品溶液-6020401批-恩格列净-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%
5min1267854-26785485.38483.488.4985.3883.488.49
2282471-28247190.04390.04
3222165-22216570.81970.82
4259142-25914282.60682.61
5282091-28209189.92289.92
6257566-25756682.10482.10
10min1307535-30753598.03399.291.7498.98100.221.72
2312753-31275399.696100.70
3309260-30926098.58399.37
4308652-30865298.38999.31
5308796-30879698.43599.43
6321894-321894102.610103.52
15min1309575-30957598.683100.151.73100.72102.181.70
2316257-316257100.813102.92
3313125-31312599.815101.70
4311336-31133699.244101.26
5310667-31066799.031101.12
6324129-324129103.322105.37
20min1310849-31084999.089100.471.69102.22103.611.67
2315886-315886100.695103.92
3314414-314414100.225103.22
4312147-31214799.503102.62
5312360-31236099.571102.76
6325420-325420103.734106.93
30min1309850-30985098.771100.551.65103.01104.811.62
2316687-316687100.950105.30
3315472-315472100.563104.67
4313304-31330499.872104.09
5312419-31241999.590103.89
6324798-324798103.536107.89
45min1309989-30998998.815100.431.57104.15105.811.55
2315536-315536100.583106.05
3315698-315698100.635105.86
4313327-31332799.879105.21
5311750-31175099.376104.78
6324104-324104103.314108.82
60min1308934-30893498.479100.221.62104.91106.721.60
2315061-315061100.432107.02
3314354-314354100.206106.55
4312460-31246099.603106.04
5311819-31181999.398105.91
6323810-323810103.221109.87
极限1308828-30882898.445100.021.53105.97107.631.52
2314508-314508100.255107.96
3313588-31358899.962107.42
4311597-31159799.328106.87
5311412-31141299.269106.88
6322677-322677102.859110.66
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号250201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%
111.043925213932683929623928223928403928830.07
211.043943423939973941700.07
单位质量响应值RSD%判断
35587.2335703.800.24数据可信
供试品溶液-6020401批-非奈利酮-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%
5min1153710-15371038.81034.4213.7338.8134.4213.72
2121074-12107430.57030.57
3114802-11480228.98628.99
4125163-12516331.60231.60
5160533-16053340.53240.53
6142730-14273036.03736.04
10min1291351-29135173.56273.861.0973.9974.241.13
2290447-29044773.33473.67
3288341-28834172.80273.12
4295731-29573174.66875.02
5296609-29660974.89075.34
6292780-29278073.92374.32
15min1340958-34095886.08785.720.4987.3486.930.47
2338918-33891885.57286.73
3339468-33946885.71186.84
4341931-34193186.33387.51
5337815-33781585.29486.58
6338048-33804885.35386.57
20min1362036-36203691.40991.240.6493.6193.400.62
2359173-35917390.68692.79
3362050-36205091.41393.50
4363894-36389491.87894.02
5357978-35797890.38592.61
6363072-36307291.67193.84
30min1380937-38093796.18295.630.6699.4098.800.63
2376576-37657695.08098.19
3380420-38042096.05199.15
4381534-38153496.33299.49
5375845-37584594.89698.13
6377285-37728595.26098.45
45min1390072-39007298.48897.950.80102.78102.180.76
2384447-38444797.068101.24
3390191-39019198.518102.68
4391476-39147698.843103.07
5384442-38444297.067101.36
6386945-38694597.699101.95
60min1393633-39363399.38798.760.71104.77104.080.68
2388029-38802997.972103.22
3393294-39329499.302104.56
4393146-39314699.264104.59
5387533-38753397.847103.21
6391163-39116398.764104.10
极限1393736-39373699.41398.590.74105.90105.010.71
2387249-38724997.775104.11
3392001-39200198.975105.34
4393161-39316199.268105.70
5387508-38750897.841104.30
6389293-38929398.291104.72
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103104883101853105513114513107723106890.16
211.193080423074963077690.13
单位质量响应值RSD%判断
27990.0027503.931.24数据可信
供试品溶液-6020502批-恩格列净-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%
5min1251529-25152980.20580.359.9380.2180.359.93
2250385-25038579.84079.84
3265339-26533984.60984.61
4260201-26020182.97082.97
5205543-20554365.54265.54
6278820-27882088.90788.91
10min1310817-31081799.11098.780.63100.0099.670.71
2308762-30876298.45599.34
3310476-31047699.00299.94
4309562-30956298.71099.63
5306652-30665297.78298.51
6312351-31235199.599100.59
15min1314227-314227100.19899.610.53102.19101.600.59
2311794-31179499.422101.40
3312273-31227399.575101.61
4312317-31231799.589101.61
5309757-30975798.772100.59
6313998-313998100.125102.22
20min1314111-314111100.16199.580.50103.27102.680.56
2311209-31120999.235102.32
3312090-31209099.516102.66
4312189-31218999.548102.67
5310189-31018998.910101.82
6314002-314002100.126103.33
30min1314561-314561100.30499.650.39104.52103.850.44
2311589-31158999.356103.54
3312183-31218399.546103.80
4312362-31236299.603103.83
5311162-31116299.220103.23
6313126-31312699.847104.17
45min1313087-31308799.83499.430.59105.17104.740.65
2309994-30999498.848104.14
3312522-31252299.654105.01
4311059-31105999.187104.53
5309848-30984898.801103.91
6314457-314457100.271105.70
60min1313043-31304399.82099.290.55106.26105.710.60
2310236-31023698.925105.32
3311276-31127699.257105.72
4310460-31046098.996105.44
5309513-30951398.694104.91
6313799-313799100.061106.60
极限1311785-31178599.41999.110.57106.97106.630.62
2308791-30879198.464105.95
3311520-31152099.334106.90
4310185-31018598.909106.45
5309204-30920498.596105.90
6313440-31344099.947107.60
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号250201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%
111.043944783944263944013950623943593945450.08
211.043916253905203910720.20
单位质量响应值RSD%判断
35737.7735423.190.63数据可信
供试品溶液-6020502批-非奈利酮-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%
5min1105374-10537426.65530.3214.7126.6530.3214.72
299737-9973725.22925.23
3128416-12841632.48332.48
4130519-13051933.01533.02
5109821-10982127.78027.78
6145384-14538436.77536.78
10min1286231-28623172.40373.682.4772.7074.022.52
2284002-28400271.83972.12
3290586-29058673.50473.87
4300390-30039075.98476.35
5286542-28654272.48272.79
6299861-29986175.85176.26
15min1337017-33701785.24986.361.4586.3587.521.49
2337753-33775385.43686.51
3340747-34074786.19387.37
4350192-35019288.58289.79
5338998-33899885.75086.86
6343760-34376086.95588.21
20min1357985-35798590.55391.861.2292.6093.981.25
2361019-36101991.32193.35
3363999-36399992.07594.21
4371069-37106993.86396.06
5361612-36161291.47193.54
6363246-36324691.88494.10
30min1379597-37959796.02096.991.0299.07100.131.04
2381649-38164996.53999.58
3384475-38447597.254100.41
4390377-39037798.747101.99
5384100-38410097.159100.24
6380498-38049896.24899.49
45min1388304-38830498.22399.510.95102.34103.730.99
2391550-39155099.044103.16
3395856-395856100.133104.37
4399161-399161100.969105.30
5393137-39313799.445103.61
6392448-39244899.271103.58
60min1391635-39163599.065100.280.98104.28105.601.01
2394189-39418999.711104.93
3398434-398434100.785106.14
4402858-402858101.904107.36
5396435-396435100.279105.55
6395100-39510099.942105.35
极限1390993-39099398.903100.361.15105.22106.791.17
2394062-39406299.679106.00
3397676-397676100.593107.06
4404561-404561102.335108.92
5397310-397310100.501106.88
6395901-395901100.144106.67
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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%
111.103099703099323098343096493099023098570.05
211.193093143084833088980.20
单位质量响应值RSD%判断
27915.0527604.830.80数据可信
供试品溶液-1批-恩格列净-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%
5min1295419-29541994.15290.684.7094.1590.684.70
2266200-26620084.84084.84
3292125-29212593.10293.10
4292949-29294993.36593.36
5268569-26856985.59585.59
6291837-29183793.01093.01
10min1319366-319366101.784100.851.44102.83101.861.40
2324182-324182103.319104.26
3312351-31235199.548100.58
4315521-315521100.559101.60
5313812-313812100.014100.97
6313347-31334799.866100.90
15min1321605-321605102.498101.481.40104.67103.611.37
2325802-325802103.835105.93
3313835-313835100.021102.16
4317239-317239101.106103.26
5316419-316419100.845102.91
6315601-315601100.584102.73
20min1322195-322195102.686101.431.45106.00104.681.41
2325466-325466103.728106.97
3313619-31361999.952103.20
4316844-316844100.980104.26
5316261-316261100.794103.98
6315086-315086100.420103.68
30min1321590-321590102.493101.531.41106.95105.911.38
2325960-325960103.886108.28
3314227-314227100.146104.51
4318386-318386101.472105.87
5316066-316066100.732105.04
6315190-315190100.453104.83
45min1321099-321099102.336101.371.40107.93106.881.37
2325586-325586103.766109.32
3314532-314532100.243105.72
4317160-317160101.081106.61
5315251-315251100.473105.89
6314729-314729100.306105.80
60min1319917-319917101.960101.031.51108.69107.671.47
2325519-325519103.745110.45
3313606-31360699.948106.54
4314653-314653100.282106.93
5314565-314565100.254106.79
6313829-313829100.019106.63
极限1320433-320433102.124101.171.34109.99108.941.31
2324091-324091103.290111.15
3312659-31265999.647107.35
4317550-317550101.205108.97
5315827-315827100.656108.31
6314160-314160100.125107.84
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)1.5
对照品批号250201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%
111.043938463938413932463935493938963936760.08
211.043933113924543928820.16
单位质量响应值RSD%判断
35659.0635587.140.15数据可信
供试品溶液-1批-非奈利酮-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%
5min1151249-15124938.21238.1814.6838.2138.1814.69
2145328-14532836.71636.72
3171633-17163343.36243.36
4169370-16937042.79142.79
5110838-11083828.00328.00
6158200-15820039.96839.97
10min1300745-30074575.98277.372.3576.4177.802.40
2308338-30833877.90078.31
3312730-31273079.01079.49
4315389-31538979.68280.16
5296743-29674374.97175.28
6303549-30354976.69077.13
15min1342585-34258586.55287.811.4387.8289.101.48
2348284-34828487.99289.27
3351451-35145188.79290.15
4355136-35513689.72391.08
5343968-34396886.90288.05
6344031-34403186.91888.21
20min1361593-36159391.35592.311.0993.5994.571.13
2365709-36570992.39594.65
3368241-36824193.03495.38
4371606-37160693.88596.24
5363132-36313291.74493.85
6361896-36189691.43193.69
30min1375506-37550694.87096.151.1698.1299.441.19
2381401-38140196.35999.64
3382586-38258696.659100.04
4387701-38770197.951101.35
5379422-37942295.85998.99
6376786-37678695.19398.47
45min1382581-38258196.65798.101.11100.96102.451.13
2388602-38860298.178102.53
3390138-39013898.567103.02
4395116-39511699.824104.31
5388060-38806098.042102.24
6385201-38520197.319101.65
60min1384187-38418797.06398.411.04102.44103.851.06
2391157-39115798.824104.26
3390676-39067698.702104.25
4395431-39543199.904105.50
5389724-38972498.462103.75
6385854-38585497.484102.90
极限1385742-38574297.45698.861.35103.91105.391.34
2391221-39122198.840105.38
3390242-39024298.593105.24
4400674-400674101.228107.94
5392694-39269499.212105.59
6387115-38711597.803104.30
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