300641大连控股-641

2021年4月26日发(作者：银行每天晚上扎帐的时候,数据都要审核你还怕个几把!兴)

Accessed from 60.212.43.237 by vp3htsiozpg on Tue Jul 24 03:47:36 EDT 2018
6376 á631? Physical TestsUSP 41
COLOR DETERMINATION AND STANDARDS
The perception of color and color matches is dependent on conditions of viewing and illumination. Determinations should
be made using diffuse, uniform illumination under conditions that reduce shadows and nonspectral reflectance to a minimum.
The surface of powders should be smoothed with gentle pressure so that a planar surface free from irregularities is presented.
Liquids should be compared in matched color-comparison tubes, against a white background. If results are |股指期货实战 found to vary with
illumination, those obtained in natural or artificial daylight are to be considered correct. Instead of visual determination, a suit-
able instrumental method may be used.
Colors of standards should be as close as possible to those of test specimens for quantifying color differences. Standards for
opaque materials are available as sets of color chips that are arranged in a visually uniform space.* Standards identified by a
letter for matching the colors of fluids can be prepared according to the accompanying table. To prepare the matching fluid
required, pipet the prescribed volumes of the colorimetric test solutions [see under Colorimetric Solutions (CS) in the section
Reagents, Indicators, and Solutions] and water into one of the matching containers, and mix the solution in the container. Make
the comparison as directed in the individual |三洋食品株式会社 monograph, under the viewing conditions previously described. The matching
fluids, or other combinations of the colorimetric solutions, may be used in very low concentrations to measure deviation from
achromicity.
Matching Fluids
Parts ofParts ofParts of
MatchingCobaltousFerricCupricParts of
FluidChloride CSChloride CSSulfate CSWater
A0.10.40.14.4
B0.30.90.33.5
C0.10.60.14.2
D0.30.60.43.7
E0.41.20.33.1
F0.31.20.03.5
G0.51.20.23.1
H0.21.50.03.3
I0.42.20.12.3
J0.43.50.11.0
K0.54.50.00.0
L0.83.80.10.3
M0.12.00.12.8
N0.04.90.10.0
O0.14.80.10.0
P0.20.40.14.3
Q0.20.30.14.4
R0.30.40.24.1
S0.20.10.04.7
s
T0.50.50.43.6
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t
p
a
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á641? COMPLETENESS OF SOLUTION
l
a
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Place the quantity of the substance specified in the individual monograph in a meticulously cleansed, glass-stoppered, 10-
mL glass cylinder approximately 13 mm × 125 mm in size. Using the solvent that is specified in the monograph or on the 银行汇率、外汇汇率
label
of the product, fill the cylinder almost to the constriction at the neck. Shake gently to effect solution: the solution is not less
clear than an equal volume of the same solvent contained in a similar vessel and examined similarly.
* Collections of color chips, arranged according to hue, value, and chroma in a visually uniform space and suitable for use in color designation of specimens by
visual matching are available from GretagMacbeth LLC, 617 Little Britain Road, New Windsor, NY 12553-6148.
Official from May 1, 2018
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.

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USP 41Physical Tests á643? 6377
á643? TOTAL ORGANIC CARBON
Total organic carbon (TOC) is an indirect measure of 银行汇率、外汇汇率
organic molecules present in pharmaceutical waters measured as carbon.
Organic molecules are introduced into the water from the source water, from purification and distribution system materials,
from biofilm growing in the system, and from the packaging of sterile and nonsterile waters. TOC can also be used as a
process control attribute to monitor the performance of unit operations comprising the purification and distribution system.
A TOC measurement is not a replacement test for endotoxin or microbiological control. Although there can be a qualitative
relationship between a food source (TOC) and microbiological activity, there is no direct numerical correlation.
A number of acceptable methods exist for analyzing TOC. This chapter does not endorse, limit, or prevent any technologies
from being used, but this chapter provides guidance on how to qualify these analytical technologies for use as well as guid-
ance on how to interpret instrument results for use as a limit test.
Apparatuses commonly used to determine TOC in water for pharmaceutical use have in common the objective of oxidizing
the organic molecules in the water to produce carbon dioxide followed by the measurement of the amount of carbon diox-
ide produced. Then the amount of CO
2
produced is determined and used to calculate the organic carbon concentration in
the water.
All technologies must discriminate between the inorganic carbon, which may be present in the water from sources such as
dissolved CO
nation may be accomplished either by determining the inorganic carbon and subtracting it from the total carbon (total car-
2
and bicarbonate, and the CO
2
generated from the oxidation of organic molecules in the sample. The discrimi-
bon is the sum of organic carbon and inorganic carbon), or by purging inorganic carbon from the sample before oxidation.
Although purging may entrain organic molecules, such purgeable organic carbon is present in negligible quantities in water
for pharmaceutical use.
PROCEDURES
? B
ULK
W
ATER
The following sections apply to tests for bulk Purified Water, Water for Injection, Water for Hemodialysis, and the condensate
of Pure Steam.
Apparatus requirements:This test method is performed either as an on-line test or as an off-line laboratory test using a
calibrated instrument. The suitability of the apparatus must be periodically demonstrated as described below. In addition, it
must have a manufacturer’s specified limit of detection of 0.05 mgL (0.05 ppm) or lower of carbon.
When testing water for quality control purposes, ensure that the instrument and its data are under appropriate control and
that the sampling approaches and locations of both on-line and off-line measurements are representative of the quality of
the water used. The nature of the water production, distribution, and use should be considered when selecting either on-
line or off-line measurement.
Reagent water:Use water having a TOC level of not more than 0.10 mgL. [N
OTE
—A conductivity requirement may be
necessary in order to ensure method reliability.]
Container preparation:Organic contamination of containers results in higher TOC values. Therefore, use labware and
containers that have been scrupulously cleaned of organic residues. Any method that is effective in removing organic mat-
ter can be used (see Cleaning Glass Apparatus á1051?). Use Reagent water for the final rinse.
Standard solution:Unless otherwise directed in the individual monograph, dissolve in the Reagent water an accurately
weighed quantity of USP Sucrose RS to obtain a solution having a concentration of 1.19 mgL of sucrose (0.50 mgL of
carbon).
System suitability solution:Dissolve in Reagent water an accurately weighed quantity of USP 1,4-Benzoquinone RS to ob-
tain a solution having a concentration of 0.75 mgL (0.50 mgL of carbon).
Reagent water control:Use a suitable quantity of Reagent water obtained at the same time as that used in the preparation
of the Standard Solution and the System suitability solution.
Water sample:Obtain an on-line or off-line sample that suitably reflects the quality of water used.
Other control solutions:Prepare appropriate reagent blank solutions or other specified solutions needed for establishing
the apparatus baseline or for calibration adjustments following the manufacturer’s instructions, and run the appropriate
blanks to zero the instrument, if necessary.
System suitability:Test the Reagent water control in the apparatus, and record the response, r
General Chapters
r
W
. Repeat the test using the
Standard solution, and record the response,
Reagent water control
S
. Calculate the corrected Standard solution response, which is also the limit
response, by subtracting the response from the response of the Standard solution. The theoretical lim-
it of 0.50 mgL of carbon is equal to the corrected Standard solution response, r
r
S
? r
W
. Test the System suitability solution in
the apparatus, and record the response,
Reagent water control response from the response of the
SS
. Calculate the corrected System suitability solution response by subtracting the
System suitability solution, r
System suitability solution:
SS
? r
W
. Calculate the percent response
efficiency for the
% response efficiency=100[(r
SS
? r
W
)(r
S
? r
W
)]
r
SS
=instrument response to the System suitability solution
Official from May 1, 2018
Copyright (c) 2018 The United States Pharmacopeial Convention. All rights reserved.

“我可看不到。”米娅说道：“那个时候，估计，我还是这么小呢。” 刘大军很恼火，但是望着无数的自行车大军，也只能放弃了。 来东门，本来就很不爽，这里人少，就和被发配了一样，现在好容易有个机会，怎么能看着刘大军溜掉？ 不过，纸上谈兵这个成语，在秦振华的身上，那可不是贬义词，我这是知识！想要当一名优秀的坦克厂的工人，不仅仅要会动手，还得会动脑子，还得学习知识！ 牛世龙顿时有种吃了屎一般的恶心。 “不过，只有这一个成果还不够，毕竟，液力变矩器本来就是匹配自动变速箱，而且是为了实现双流传动的。”秦振华说道：“不过呢，现在也只能研究这么多了，毕竟，没有新的底盘，也没法搞新的项目。” “噗。”宋伟泽喝到嘴里的一口水，顿时就喷了出来，他赶紧咳嗽两声，装出意外的样子来。