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Usp36-Nf31 03 85

This document provides standards for lincomycin hydrochloride and lincomycin hydrochloride capsules. It specifies that lincomycin hydrochloride has a potency of not less than 790 μg of lincomycin per mg. It also specifies that lincomycin hydrochloride capsules contain an amount of lincomycin equivalent to not less than 90.0% and not more than 120.0% of the labeled amount. The document describes tests for dissolution, uniformity of dosage units, and water content for the capsules.

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242 views1 page

Usp36-Nf31 03 85

This document provides standards for lincomycin hydrochloride and lincomycin hydrochloride capsules. It specifies that lincomycin hydrochloride has a potency of not less than 790 μg of lincomycin per mg. It also specifies that lincomycin hydrochloride capsules contain an amount of lincomycin equivalent to not less than 90.0% and not more than 120.0% of the labeled amount. The document describes tests for dissolution, uniformity of dosage units, and water content for the capsules.

Uploaded by

Jose Luis Huaman
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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4118 Lincomycin / Official Monographs USP 36

is about 1 mL per minute. Chromatograph the Standard


preparation, and record the responses as directed for Proce-
Lincomycin Hydrochloride
.

dure: the tailing factor for the main lincomycin peak is not
more than 1.3; the column efficiency determined from the
main lincomycin peak is not less than 4000 theoretical
plates; and the relative standard deviation for replicate injec-
tions is not more than 2.0%.
Procedure—Separately inject equal volumes (about 20 µL)
of the Standard preparation and the Assay preparation into
the chromatograph, record the chromatograms, and meas-
ure the areas for the major peaks. The relative retention
times are about 0.5 for lincomycin B and 1.0 for lincomycin.
C18H34N2O6S · HCl · H2O 461.01 Calculate the quantity, in µg, of lincomycin (C18H34N2O6S) in
D-erythro-α-D-galacto-Octopyranoside, methyl 6,8-dideoxy-6- each mg of the Lincomycin Hydrochloride taken by the
[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl]amino]-1- formula:
thio-, monohydrochloride, monohydrate, (2S-trans)-.
Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L- 10(CP / W)(rU / rS)
2-pyrrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-
octopyranoside monohydrochloride monohydrate in which C is the concentration, in mg per mL, of USP
[7179-49-9]. Lincomycin Hydrochloride RS in the Standard preparation; P
Anhydrous 443.01 [859-18-7]. is the designated potency, in µg of lincomycin per mg, of
USP Lincomycin Hydrochloride RS; W is the weight, in mg,
» Lincomycin Hydrochloride has a potency equiv- of the portion of Lincomycin Hydrochloride taken to prepare
alent to not less than 790 µg of lincomycin the Assay preparation; and rU and rS are the lincomycin peak
(C18H34N2O6S) per mg. responses obtained from the Assay preparation and the Stan-
dard preparation, respectively.
Packaging and storage—Preserve in tight containers.
Labeling—Where it is intended for use in preparing inject-
able dosage forms, the label states that it is sterile or must
be subjected to further processing during the preparation of
injectable dosage forms. Lincomycin Hydrochloride Capsules
.

USP Reference standards 〈11〉—


USP Endotoxin RS » Lincomycin Hydrochloride Capsules contain an
USP Lincomycin Hydrochloride RS amount of C18H34N2O6S · HCl · H2O equivalent to
Identification, Infrared Absorption 〈197M〉. not less than 90.0 percent and not more than
Specific rotation 〈781S〉: between +135° and +150°. 120.0 percent of the labeled amount of linco-
Test solution: 20 mg per mL, in water. mycin (C18H34N2O6S).
Crystallinity 〈695〉: meets the requirements.
pH 〈791〉: between 3.0 and 5.5, in a solution (1 in 10). Packaging and storage—Preserve in tight containers.
Water, Method I 〈921〉: between 3.0% and 6.0%. USP Reference standards 〈11〉—
Limit of lincomycin B—Use the chromatogram obtained USP Lincomycin Hydrochloride RS
from the Assay preparation in the Assay: the area of the Dissolution 〈711〉—
lincomycin B peak is not greater than 5.0% of the sum of Medium: water; 500 mL.
the areas of the lincomycin B peak and the lincomycin peak. Apparatus 1: 100 rpm.
Other requirements—Where the label states that Linco- Time: 45 minutes.
mycin Hydrochloride is sterile, it meets the requirements for
Sterility and Bacterial endotoxins under Lincomycin Injection. Procedure—Filter a portion of about 20 mL of the solution
Where the label states that Lincomycin Hydrochloride must under test. Transfer about 5 mL of the eluant into a small
be subjected to further processing during the preparation of test tube, and add 250 µL of 0.01 M sodium sulfate internal
injectable dosage forms, it meets the requirements for Bacte- standard solution. Evaporate until dry using a vacuum cen-
rial endotoxins under Lincomycin Injection. trifuge. Add 10.0 µL of water to the precipitate and place
on a vortex mixer until all solid material is dissolved. Trans-
Assay— fer this solution to a capillary tube, place it in a Raman
Mobile phase—Add 13.5 mL of phosphoric acid to spectrometer, and obtain the Raman spectrum using suita-
1000 mL of water, and adjust with ammonium hydroxide to ble instrumental conditions (see Spectrophotometry and
a pH of 6.0. Prepare a filtered and degassed mixture of this Light-scattering 〈851〉). Integrate the Raman intensity, apply-
solution, acetonitrile, and methanol (780:150:150). Make ing baseline corrections, between 660 cm−1 and 720 cm−1.
adjustments if necessary (see System Suitability under Chro- Divide this result by the integrated intensity between
matography 〈621〉). 966 cm−1 and 994 cm−1. Determine the amount of
Standard preparation—Dissolve an accurately weighed C18H34N2O6S dissolved in comparison with an aqueous Stan-
quantity of USP Lincomycin Hydrochloride RS in Mobile dard solution having a known concentration of USP Linco-
phase to obtain a solution having a known concentration of mycin Hydrochloride RS.
about 1.2 mg per mL, using sonication if necessary to effect Tolerances—Not less than 75% (Q) of the labeled amount
solution. of C18H34N2O6S is dissolved in 45 minutes.
Assay preparation—To about 12 mg of Lincomycin Hydro- Uniformity of dosage units 〈905〉: meet the require-
chloride, accurately weighed, add 10.0 mL of Mobile phase. ments.
Shake by mechanical means for 5 minutes, and sonicate if Water, Method I 〈921〉: not more than 7.0%.
necessary to effect solution.
Assay—
Chromatographic system (see Chromatography 〈621〉)—The
liquid chromatograph is equipped with a 210-nm detector Mobile phase, Standard preparation, and Chromatographic
and a 4.6-mm × 25-cm column that contains 5-µm packing system—Proceed as directed in the Assay under Lincomycin
L7 and is maintained at a temperature of 46°. The flow rate Hydrochloride.

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