4324Suprofen / Official Monographs
USP 34
Procedure—Proceed as directed in the Assay under Suprofen .or chemical means so as to provide greater resis-Calculate the quantity, in mg, of C 14H 12O 3S in each mL of the tance to absorption in living mammalian tissue.
Ophthalmic Solution taken by the formula:
Packaging and storage—Prerve dry or in fluid, in contain-1250(C /V )(r U /r S )
ers (packets) so designed that sterility is maintained until the container is opened. A number of such containers may be in which C is the concentration, in mg per mL, of USP Suprofen placed in a box.
RS in the Standard preparation, V is the volume, in mL, of Labeling—The label of each individual container (packet) of Ophthalmic Solution taken, and r U and r S are the peak re-Suture indicates the size, length, type of Suture, kind of needle spons obtained from the Assay preparation and the Standard (if a needle is included), number of sutures (if multiple), lot
preparation, respectively.
number, and name of the manufacturer or distributor. If remov-
able needles are ud, the labeling so indicates. Suture size is designated by the metric size (gauge number) and the corre-sponding USP size. The label of the box indicates also the ad-dress of the manufacturer, packer, or distributor, and the com-Absorbable Surgical Suture
position of any packaging fluids ud.
NOTE —If the Suture is packaged with a fluid, make the re-» Absorbable Surgical Suture is a sterile, flexible quired measurements for the first four of the following tests strand prepared from collagen derived from within 2 minutes after removing it from the fluid.
healthy mammals, or from a synthetic polymer.Length—Determine the length of Suture without stretching:Suture prepared from synthetic polymer may be the length of each strand is not less than 95.0% of the length stated on the label.
in either monofilament or multifilament form. It Diameter—Determine the diameter of 10 strands of Suture as is capable of being absorbed by living mamma-directed under Sutures—Diameter 〈861〉.阴户
lian tissue, but may be treated to modify its resis-Collagen suture—The average diameter, and not fewer than tance to absorption. Its diameter and tensile 20, of the 30 measurements on the 10-strand sample are within strength correspond to the size designation indi-the limits on average diameter prescribed in Table 1 for the cated on the label, within the limits prescribed respective size. None of the individual measurements is less than the midpoint of the range for the next smaller size or herein. It may be modified with respect to body more than the midpoint of the range for the next texture. It may be impregnated or treated Synthetic suture—The average diameter of the strands being with a suitable coating, softening, or antimicro-measured is within the tolerances prescribed in Table 2 for the bial agent. It may be colored by a color additive respective size. None of the obrved measurements is less than approved by the FDA. The collagen suture is des-the midpoint of the range for the next smaller size or more ignated as either Plain Suture or Chromic Suture .than the midpoint of the range for the next larger size.
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Both types consist of procesd strands of colla-gen, but Chromic Suture is procesd by physical
Table 1. Collagen Suture
Limits on Knot-Pull Knot-Pull Average Tensile Strength
Tensile Strength
Diameter (mm)
(kgf)
(in N)
Limit Limit Metric Limit on on
Size on Individual Limit on Individual USP
(Gauge Average Strand Average Strand Size No.)Min.Max.Min.Min.Min.Min.9-00.40.0400.049————8-00.50.0500.0690.0450.0250.440.247-00.70.0700.0990.070.0550.690.546-010.100.1490.180.10 1.760.985-0 1.50.150.1990.380.20 3.73 1.964-020.200.2490.770.407.55 3.923-030.300.339 1.250.6812.2 6.672-0 3.50.350.399 2.00 1.0419.610.2040.400.499 2.77 1.4527.214.2150.500.599 3.80 1.9537.319.1260.600.699 4.51 2.4044.225.5370.700.799 5.90 2.9957.829.34
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登记官0.800.899
7.00
3.49
68.634.2area 11
USP 34Official Monographs / Suture4325
11-00.10.0100.019——
10-00.20.0200.0290.025*0.24*
9-00.30.0300.0390.050*0.49*
8-00.40.0400.0490.070.69
7-00.50.0500.0690.14 1.37
6-00.70.0700.0990.25 2.45
5-010.100.1490.68 6.67
4-0 1.50.150.1990.959.32
3-020.200.249 1.7717.4
2-030.300.339 2.6826.3
0 3.50.350.399 3.9038.2
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140.400.499 5.0849.8
250.500.599 6.3562.3
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3 and 460.600.6997.2971.5
570.700.799——
*The tensile strength of the specified USP size is measured by straight pull.
Weigh a quantity of Suture, equivalent to not less than Tensile strength—Determine the tensile strength on not250mg, and place in a conical flask containing 1.0mL of water fewer than 10 strands of Suture as directed for Surgical Sutures for each 10mg of the sample. Clo the flask, and allow it to under Tensile Strength 〈881〉.stand at 37±0.5° for 24 hours. Cool, decant the water from Collagen suture—The tensile strength, determined as the the Suture, and compare it with the Matching Solution: any minimum strength for each individual strand tested, and calcu-color prent is not more inten than that of the appropriate lated as the average strength from any one lot, is as t forth in Matching Solution.
Table 1. If not more than one strand fails to meet the limit on Soluble chromium compounds—Pipet 5mL of the fluid pre-individual strands, repeat the test with not fewer than 20 addi-pared as directed in the test for Extractable color into a small tional strands: the requirements of the test are met if none of test tube. Into a similar tube pipet 5mL of a standard solution the additional strands falls below the limit on individual strands,of potassium dichromate having a concentration of 2.83µg per a
nd if the average strength of all the strands tested does not mL. To both tubes add 2mL of a 1 in 100 solution of diphenyl-fall below the stated limit in Table 1.carbazide in alcohol and 2mL of 2N sulfuric acid: any color Synthetic suture—The minimum tensile strength of each size that develops in the test solution is not more inten than that of synthetic suture, calculated as the average strength from any in the standard solution (0.0001% of Cr).
中译西one lot, is as t forth in Table 2.
Needle attachment—Suture on which eyeless needles are
swaged meets the requirements under Sutures—Needle Attach-
ment 〈871〉.Nonabsorbable Surgical Suture
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Sterility 〈71〉:meets the requirements.新概念第一册视频
Extractable color (if Suture is dyed)—Prepare the Matching» Nonabsorbable Surgical Suture is a flexible Solution that corresponds to the extractable color of the Suture strand of material that is suitably resistant to the by combining the Colorimetric Solutions in the proportions in-
dicated in Table 3, and adding water, if necessary, to make 10.0action of living mammalian tissue. It may be in parts. [See under Solutions in the ction Reagents, Indicators,either monofilament or multifilament form. If it is and Solutions, for composition of the Colorimetric Solutions a multifilament strand, the individual filaments (CS).]may be combined by spinning, twisting, braid-
ing, or any combination thereof. It may be either Table 3. Matching Solutions sterile or nonsterile. Its diameter and tensile
strength correspond to the size designation indi-
Parts of Each CS per
10 Parts of Total Volume cated on the label, within the limits prescribed Color of Suture Cobaltous Ferric Cupric herein. It may be modified with respect to body (Extractable Col-Chloride Chloride Sulfate or texture, or to reduce capillarity, and may be or)CS CS CS suitably bleached. It may be impregnated or Yellow-brown0.2 1.2—treated with a suitable coating, softening, or anti-Pink-red 1.0——microbial agent. It may be colored by a color Green-blue—— 2.0additive approved by the FDA.
Violet 1.6—8.4Nonabsorbable Surgical Suture is clasd and
typed as follows. Class I Suture is compod of
