(live)

1. 3 2. 4 3. 3.1. 5 3.2. 8 3.2.1. 8 3.2.2. 11 3.2.3. 13 3.2.4. 14 3.3. 18 3.3.1. 19 3.3.2. 25 3.4. (Validation) 30 3.5. 32 4. 36 5. 38 6. 42 7. 44 1

2

1.,,,... ( : ).... ( ).. (3.1 " " ).. (5. " " ). 3

2..,.,, (3.3.1 " " ). ( : )..,,. 4

3. 3.1.. ( )..,,......,.. IR 5

( ). I0 I0 IRef IL A IRef I0 IRef I0 A A A IL IL IL IL IRef........ 6

( (AK).,.. ( t) ( g). 5. HR83.. AK 1(1 mg/10s): AK 2(1 mg/20s): AK 3(1 mg/50s): AK 4(1 mg/90s): AK 5(1 mg/140s): ( : ) g t = (1...5) ( g t. AK.. 7

3.2. 3.2.1... (, ). :.. Menu 3 Vibra high ( )... 8

.. ( 1m )....! ( ). + 40 C max. + 5 C min. (% RH) 45 ~ 60%. 20 ~ 80% RH. Maximal-Bereich 20-80%.. 9

. (= ). :...... ().. 10

3.2.2.... /.. : 30.. (feet screw)..... -, -, -, - ( ). 11

.. : ( ).. :.. IPac Moisture METTLER TOLEDO IPac Moisture,. IPac Moisture,. 12

3.2.3.,. ( : ). ( ). ( : ).. ().. ( ). METTLER TOLEDO,. : HR83 50 C ~ 180 C ( 130 C). www.mt.com/smartcal 13

3.2.4..,,, /, /.. ( 1). (,,, ). (fume cupboard) ( ). :. :... :.... 14

. ( ).. ( ) ( ).. ().. ( ).., ( ). :. 15

...... ( ). 16

: 0,1 g 0,1 g 5 g.. ( ): 2g 1 : 0.05% 10g 1 : 0.01% 1 (, ). ( : HR83). ( ). 17

3.3..,.. ( )., (3.1 " " )....... ( ). 3., ( ).,. 18

() () () () (= ) 3.3.1. "3.2 ".... ( ). (3.2.4 " " ). 1. : METTLER TOLEDO..? METTLER TOLEDO.. www.mt.com/moisture-methods 19

.. 3 g 5 g : 1) 2) : (-) : 105 C, ( -) : 150 C 3(1 mg/50s) 3-5g ( ). : 3.3.2 " " 3.2.4 " " " ". : LabX Direct Moisture PC.. % MC -70-60 -50-40 -30-20 -10 00,00 01,00 02,00 03,00 04,00 05,00 06,00 07,00 08,00 [ : ] 0 20

2.... RW = %MC %MC RW RW.... %MC %MC %MC RW RW RW...... ( ). 3. 21

3.... 4(1mg/90s) 5(1mg/140s). 4..... 30%. HR83.. HG63 HR83 AutoMet (HR83 ).. 22

.. ( ). + 13,5 (% MC) + 12,5 + 11,5 103 C 1 2 3 4 5 + 10,5 80 90 100 110 120 130 140 150 180 ( C) 4. 103 C. 90 C 150. 5. 3 110 C 2 130 C. 3 4. 2. 23

AutoMet (HR83 ) AutoMet. "".. "F". AutoMet "F". F 1mg/20 1mg/180. : (, ) AutoMet. F. : 1mg/20-180,. "F" 1mg/20. "F" 1mg/180 5.. 24

3.3.2......,... (> 30%). 3 40%. (HR83 )... 25

.... MC<1% ( 20-30 g)., 5(1mg/140s). (0.1mg) (HR83 ). (HR83 ). 1.. ( ). IR.. ( )... 26

. ( 110 C )....... ( ). (, 3.2.4 " " ).. ( : )... 27

(HA-CAGE).. HA-CAGE.... (0.1 mg, HR83 ) (100 C) (1: 5, 2: 0 ) 5 30 g 1. ( ) ( : 0.1%). 30g.. 5. 28

0... 29

3.4. (Validation)... 1.). ( ). USP/Ph. Eur HR83 1g 1g 105 C 105 C - - 5 (, n = 6) 1.68% 1.68% 0.01% 0.03% 2.)... 0.4% 2.6%. 30

... HR83. 10. 2.80 2.40 % MC 2.00 1.60 1.20 0.80 0.40 0.00 0.00 0.40 0.80 1.20 1.60 2.00 2.40 2.80 HR83 % MC 31

3.5. ( ),. METTLER TOLEDO. www.mt.com/moisture-methods [g] [ C] [ %] [ ] TS 8 a 1 105 1.68 0.01 120 ( ) TS 8 b 1 130 11.47 0.05 90 TS 8 b 1 105 11.57 0.03 120, TS 8 b 1 105 11.57 0.03 120 TS 9 a 10 103 88.94 0.05 180 TS 10 a 2 102 15.13 0.07 240 TS 11 a 5 102 74.95 0.02 240 TS 12 a 5 131 11.29 0.10 90 TS 13 a 5 102 3.02 0.01 240 TS 14 a 5 102 1.03 0.01 240 TS 15 a 2.5 102 84.17 0.22 240 PA66 KF 16 c 1 190 0.2024 0.007 40 PET KF 16 c 2 180 0.0501 0.001 40 ABS KF 16 c 1 170 0.2416 0.001 40 TS: KF: 32

. METTLER TOLEDO. METTLER TOLEDO.. [g] [ C] [ %] [ ] HR83 1 1 STD 105 5 1.68 0.03 6 HR83 1 3 STD 130 5 11.81 0.05 8 HR83 1 4 STD 105 5 11.37 0.06 30 HR83 1 4 R 130 3 11.63 0.07 8 HB43-S 2 2 R 130 3 88.86 0.05 5 HB43-S 3 3 STD 110 3 15.11 0.09 5 HB43-S 4 3 STD 150 3 75.04 0.10 15 HB43-S 5 5 STD 150 3 11.34 0.08 15 HB43-S 1 1 STD 100 3 3.05 0.06 4 HB43-S 6 5 STD 135 3 1.06 0.03 6 HB43-S 1 2.5 R 130 3 84.17 0.05 15 HR83 7 30 ST 160 5 0.204 0.002 20 HR83 7 30 ST 160 5 0.048 0.002 9 HR83 7 30 ST 130 5 0.243 0.003 19 R: STD: ST: 33

1, (Spatula). 2. 3. 4. 5,. 6. 7. : 5, 0, ( ). 8 ( 1 ).. 9 ( 8cm) 10g, (103 C, 30 ). 30. 10 ( 5cm) (102 C, 1).. 34

11 20g, (102 C, 1).. 12 (131 C, 1).. 13 (103 C, 1).. 14 (102 C, 1).. 15 10g, (102 C, 1).. 16 (100 C, 1).. a b c.... 35

4... * *. IR.. IR... {174} ( 5 15 ) / ( 3 10 ) ( 2 5 ) () 36

* *.... / IR / (15 30 ) (1 ) (1 ) ( ) : ( : ) * METTLER TOLEDO. 37

5. ( ):.. (,, ). :. / : ( ) -.. :. ( : ) ( : ). : (). (, ). :... (, USP 1) ). : ( ) ( g). 38 1) USP : [USP<731>]

: A.,,. (): (380-780 nm) (780 nm-1 mm).. :. ( ) ([ISO 2) 5725] 3.7). : (). :. ( ). :. :. :,. ( )...,, (,, ). 2) ISO 39

: xi = i n:, 10. : [DIN 3) 55350-13]... : ( ). 3) DIN (German Institute for Standardization) 40

( ):. (EQ), (DQ), (IQ), (OQ), (PQ) (MQ). DQ: IQ:. OQ:. PQ:. MQ:,,. (Validation): ( ). (): (). : : (). 41

6. A AutoMet 24 I IPac 12 L LabX 20 20, 21 7, 38 4, 6, 18, 19, 20, 30, 32, 36, 38 38 12, 41 30, 41 30 8 12, 13, 41 37 4, 18, 19, 36, 38 9 11 36 37 18, 19, 30, 32, 39 18, 19, 24, 30 21, 38 16, 27, 39 14, 18, 19 14 15, 19, 22 7, 14, 16, 17, 22 8, 19, 41 26 3, 5, 16, 26, 38 37 14, 20, 27 15, 25 3, 5, 36, 38 6, 9, 14, 18, 20, 23, 24 15, 25, 26, 28 13, 41 9 5, 6, 39 5, 36 37 32 7, 22, 24 18, 22, 39 10 11, 13, 41 13, 41 32, 37, 38 42

36 3, 5 6, 36 43

7. Berliner M. A., Feuchtemessung, VEB Verlag Berlin, 1980 Krahl T., Schnellbestimmer für Materialfeuchte und Wassergehalt, Goltze, Göttingen, 1994 Lück W., Feuchtigkeit. Grundlagen, Messung, Regelung, Oldenbourg Verlag, Munich, 1964 Nater R., Reichmuth A., Schwartz R., Borys M., Zervos P., Wägelexikon, Springer Verlag 2008 Schubnell M., Methodenentwicklung in der thermischen Analyse: Teil 1, UserCom 1/2005, METTLER TOLEDO, 2005 Schubnell M.,Methodenentwicklung in der thermischen Analyse: Teil 2, UserCom 2/2005, METTLER TOLEDO, 2005 Wagner M., Bestimmung der Adsorption/Desorption von Feuchtigkeit und pharmazeutischen Substanzen, UserCom 1/2005, METTLER TOLEDO, 2005 Wernecke R., Industrielle Feuchtemessung, Wiley, Weinheim, 2003 Schweizerisches Lebensmittelbuch, Bundesamt für Gesundheit, Abteilung Lebensmittelsicherheit, Berne Wägefibel, Richtiges Wägen mit Laborwaagen, METTLER TOLEDO, 2008 Methoden der Feuchtegehaltsbestimmung, METTLER TOLEDO, 2002 (Validation of Titration Methods), METTLER TOLEDO, 1997, (Guidelines for Result Check, Method Validation and Instrument Certification), METTLER TOLEDO, 1997 44

8. HB43-S / HS153 / HX204 ( 90 mm) MT, HA-D90 13865 80 ( ) 11113863 80, HA-CAGE ( ) 214695 1, HA-F1 214464 100 RS-P42 (RS232 ) 229265 RS-P25 (RS232 ) 11124300 00072456 5 / ( ) 11600388 3 /, 00065975 2 HA-ETTC, HX/HS 30020851 HA-TTC, (HB/MJ/HR/HG) 214528 csmartcal(, 24) 30005791 csmartcal(, 12) 30005793 SmartCal(24) 30005790 SmartCal(12) 30005792 StartPac csmartcal (, 12 ) 30005918 HX, 200 g 11119532 HS, 100 g 11119531 HB/MJ, 20 g 11119529 HX/HS 30003957 1 HB43-S 11113363 2 / HX/HS 30018474 1 HX/HS 30020838 50 HX/HS 30066692 1 45

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