NDA 17-037/S-158
Page 23
HEP-LOCK U/P
Preservative-Free
(Heparin Lock Flush Solution, USP)
R
x
only
DESCRIPTION
Heparin is a heterogeneous group of straight-chain
anionic mucopolysaccharides, called
glycosaminoglycans, having anticoagulant properties. Although
others may be present, the main sugars
occurring in heparin are: (1)
α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-
sulfate, (3)
β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid.
These sugars are
present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5), and are
joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of
its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium,
the acidic
protons of the sulfate units are partially replaced by sodium ions.
Structural formula of Heparin Sodium (representative sub-units):
HEP-LOCK U/P (Preservative-Free Heparin Lock Flush Solution, USP) is a sterile solution for
intravenous flush only. It is not to be used for anticoagulant therapy. HEP-LOCK U/P
is specially
formulated for use in situations where the use of preservatives is not advisable. Each mL contains
heparin sodium 10 or 100
USP units, derived from porcine intestines and standardized for use as an
anticoagulant, sodium chloride 8 mg, monobasic sodium phosphate monohydrate 2.3 mg
,
and
dibasic
sodium phosphate anhydrous 0.5 mg in Water for Injection. pH 5.0-7.5. The potency is determined by
biological assay using a USP reference standard based on units of heparin activity per milligram.
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