Accessed from 10.6.1.
1 by merck1 on Sun Jun 05 05:46:09 EDT 2016
4122 Glipizide / Official Monographs
Total impurities: NMT 1.0%, excluding glipizide re-
lated compound A. [NOTE—Disregard the broad peak
due to metformin that elutes before 8 min. Disregard
any peak observed in the blank, and disregard any
peak less than 0.05%.]
• PROCEDURE 2: METFORMIN HYDROCHLORIDE
Solution A, Solution B, Mobile phase, Sample solu-
tion, and Chromatographic system: Prepare as di-
rected in the Assay for Metformin Hydrochloride.
Analysis
Sample: Sample solution
Calculate the percentage of each impurity in the por-
tion of Tablets taken:
Result = (rU/rT) × 100
rU = peak response for each impurity
rT = sum of all the peak responses
Acceptance criteria
Individual impurities: NMT 0.1%
Total impurities: NMT 0.5%
[NOTE—Disregard any peak less than 0.05%. Disre-
gard any peak observed in the blank.]
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in well-closed contain-
ers, and store at controlled room temperature.
• LABELING: When more than one Dissolution test is given,
the labeling states the Dissolution test used only if Test 1
is not used.
• USP REFERENCE STANDARDS 〈11〉
USP Glipizide RS
USP Glipizide Related Compound A RS
N-{2-[(4-Aminosulfonyl)phenyl]ethyl}-5-methyl-
pyrazinecarboxamide.
C14H16N4O3S 320.37
USP Metformin Hydrochloride RS
USP Metformin Related Compound A RS
USP Monographs
1-Cyanoguanidine.
Immune Globulin
.
» Immune Globulin conforms to the regulations
of the FDA concerning biologics (640.100 to
640.104) (see Biologics 〈1041〉). It is a sterile,
nonpyrogenic solution of globulins that contains
many antibodies normally present in adult
human blood, prepared by pooling approxi-
mately equal amounts of material (source blood,
plasma, serum, or placentas) from not less than
1000 donors. It contains not less than 15 g and
not more than 18 g of protein per 100 mL, not
less than 90.0 percent of which is gamma globu-
lin. It contains 0.3 M glycine as a stabilizing
agent and contains a suitable preservative. It has
a potency of component antibodies of diphtheria
antitoxin based on the U.S. Standard Diphtheria
Antitoxin and a diphtheria test toxin, tested in
guinea pigs (not less than 2 antitoxin units per
mL), and antibodies for measles and poliovirus. It
meets the requirements of the tests for heat sta-
bility in absence of gelation on heating, and for
pH.
Packaging and storage—Preserve at a temperature be-
tween 2° and 8°.
Official from May 1, 2016
Copyright (c) 2016 The United States Pharmacopeial Convention. All rights reserved.
USP 39
Expiration date—The expiration date is not later than 3
years after date of issue from manufacturer’s cold storage
(5°, 3 years).
Labeling—Label it to state that passive immunization with
Immune Globulin modifies hepatitis A, prevents or modifies
measles, and provides replacement therapy in persons hav-
ing hypo- or agammaglobulinemia, that it is not standard-
ized with respect to antibody titers against hepatitis B sur-
face antigen and that it should be used for prophylaxis of
viral hepatitis type B only when the specific Immune Globu-
lin is not available, that it may be of benefit in women who
have been exposed to rubella in the first trimester of preg-
nancy but who would not consider a therapeutic abortion,
and that it may be used in immunosuppressed patients for
passive immunization against varicella if the specific Immune
Globulin is not available. Label it also to state that it is not
indicated for routine prophylaxis or treatment of rubella,
poliomyelitis, or mumps, or for allergy or asthma in patients
who have normal levels of immunoglobulin, that the plasma
units from which it has been derived have been tested and
found non-reactive for hepatitis B surface antigen, and that
it should not be administered intravenously but be given
intramuscularly, preferably in the gluteal region.
Rho (D) Immune Globulin
.
» Rho (D) Immune Globulin conforms to the reg-
ulations of the FDA concerning biologics (see Bio-
logics 〈1041〉). It is a sterile, nonpyrogenic solu-
tion of globulins derived from human blood
plasma containing antibody to the erythrocyte
factor Rho (D). It contains not less than 10 g and
not more than 18 g of protein per 100 mL, not
less than 90.0 percent of which is gamma globu-
lin. It has a potency, determined by a suitable
method, not less than that of the U.S. Reference
Rho (D) Immune Globulin. It contains 0.3 M gly-
cine as a stabilizing agent and contains a suitable
preservative.
Packaging and storage—Preserve at a temperature be-
tween 2° and 8°.
Expiration date—The expiration date is not later than 6
months from the date of issue from manufacturer’s cold
storage, or not later than 1 year from the date of manufac-
ture, as indicated on the label.
.
Glucagon
C153H225N43O49S 3482.75
Glucagon (human) [16941-32-5].
DEFINITION
Glucagon is a polypeptide hormone that has the property of
increasing the concentration of glucose in the blood. It
has the same structure (29 amino acids) as the hormone
produced by the α-cells of the human pancreas. Glucagon
is produced by microbial processes using recombinant
DNA (rDNA) technology. The host cell–derived protein
content and/or the host cell–derived or vector-derived
DNA content are determined by validated methods. Dur-
ing the course of product development, it must be dem-
onstrated that the manufacturing process produces Glu-