华夏沪深300300641-641

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)

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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 江南红箭股票 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 涨停板博客 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 股票002340 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
r
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t
p
a
h
C

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 label
of the product, fill the cylinder almost to the constriction at the neck. 国中水务股吧 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 organic molecules present in pharmaceutical waters measured as carbon.
Organic 华泰大智慧交易软件 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 东方航空股吧 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.

------------ “振华啊，这就是你的不对了。”难得李长江也跟着附和这么一句：“他们研发室，也不是什么都懂的，你得反复叮嘱他们才行，你肚子里的墨水，可比他们多啊，看看昨天的大比武就知道了。” 还好，现在正好是中午，工厂的老师傅们，吃过了午饭，会找个地方眯一会儿，沿途没看到什么人。 祝老，我们研发室里这么多技术人员，您一个都看不上吗？开口闭口就提秦振华？ 马盼山的心情也正不爽着呢，所以，周学军也无法再给马盼山说什么了，明天，该怎么说服秦振华？