Accessed from 128.83.63.

20 by nEwp0rt1 on Mon Nov 21 22:16:54 EST 2011

2242 Articaine / Official Monographs USP 35

Impurity Table 1 (Continued) DEFINITION

Relative Acceptance
Ascorbic Acid contains NL T 99.0% and NMT 100.5% of
Retention Criteria,
C6H8O6.
Name Time NMT (%) IDENTIFICATION
Articaine related 0.86 0.1 • A. INFRARED ABSORPTION 〈197K〉
compound E d • B. A 20-mg/mL solution reduces alkaline cupric tartrate TS
Articaine acid- 0.9 0.1 slowly at room temperature but more readily upon heating.
propionamidee
Articaine 1.0 — ASSAY
• PROCEDURE
Butylarticainef 1.7 0.1
Sample: 400 mg of Ascorbic Acid
Dipropylarticaineg 2.1 0.1 Titrimetric system
3-Aminoarticaineh 2.6 0.1 (See Titrimetry 〈541〉.)
Articaine isopropyl ester i 3.6 0.1 Mode: Direct titration
Bromo compound j 4.0 0.1 Titrant: 0.1 N iodine VS
Any other individual — 0.10 Endpoint detection: Visual
impurity Blank: 100 mL of water and 25 mL of 2 N sulfuric acid.
Add 3 mL of star ch TS.
a 4-Methyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-
Analysis: Dissolve the Sample in a mixture of 100 mL of
carboxylic acid.
b Methyl 3-[[(2RS)-2-(ethylamino)propanoyl]amino]-4-methylthiophene-2-
water and 25 mL of 2 N sulfuric acid. Add 3 mL of star ch
TS, and titrate immediately with Titrant until a persistent vio-
carboxylate.
c Methyl 4-methyl-3-[2-(propylamino)acetamido]thiophene-2-carboxylate.
let-blue color is obtained.
d Methyl 3-[2-(isopropylamino)propanamido]-4-methylthiophene-2-
Calculate the per centage of ascorbic acid (C 6H8O6) in the
portion of Ascorbic Acid taken:
carboxylate.
e 4-Methyl-N-propyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-
Result = [( V − B) × N × F × 100]/W
2-carboxamide.
f Methyl 3-[[(2RS)-2-(butylamino)propanoyl]amino]-4-methylthiophene-2-
V = sample titrant volume (mL)
carboxylate. B = blank titrant volume (mL)
g Methyl 3-[[(2RS)-2-(dipropylamino)propanoyl]amino]-4-methylthiophene-
N = titrant normality (mEq/mL)
2-carboxylate. F = equivalency factor, 88.06 mg/mEq
h Methyl 3-amino-4-methylthiophene-2-carboxylate.
W = weight of Sample (mg)
i 1-Methylethyl 4-methyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]
Acceptance criteria: 99.0%–100.5%
thiophene-2-carboxylate.
j Methyl 3-[[(2RS)-2-bromopropanoyl]amino]-4-methylthiophene-2- IMPURITIES
carboxylate. • RESIDUE ON IGNITION 〈281〉: NMT 0.1%
• HEAVY METALS 〈231〉
SPECIFIC TESTS Sample solution: 1 g in 25 mL of water
• LOSS ON DRYING 〈731〉: Dry at 105 ° for 5 h: it loses NMT Acceptance criteria: NMT 20 ppm
0.5% of its weight.
• PH 〈791〉 SPECIFIC TESTS
Sample solution: 10 mg/mL • OPTICAL ROTATION, Specific Rotation 〈781S〉
Acceptance criteria: 4.2–5.2 Sample solution: 100 mg/mL in carbon dioxide-free water.
Perform the test immediately after preparation of the Sample
ADDITIONAL REQUIREMENTS solution.
• PACKAGING AND STORAGE: Preserve in light-resistant Acceptance criteria: +20.5° to +21.5 °
containers.
• USP REFERENCE STANDARDS 〈11〉 ADDITIONAL REQUIREMENTS
USP Articaine RS • PACKAGING AND STORAGE: Preserve in tight, light-resistant
USP Articaine Hydrochloride RS containers.
USP Articaine Related Compound A RS • USP REFERENCE STANDARDS 〈11〉
Methyl 4-methyl-3-[2-(propylamino) acetamido]thiophene- USP Ascorbic Acid RS
2-carboxylate.
C12H18N2O3S 270.35
USP Articaine Related Compound E RS
Methyl 3-[2-(isopropylamino) propanamido]-4- .

methylthiophene-2-carboxylate. Ascorbic Acid Injection

C13H20N2O3S 284.37
» Ascorbic Acid Injection is a sterile solution, in
Water for Injection, of Ascorbic Acid prepared
.

with the aid of Sodium Hydroxide, Sodium Car-

Ascorbic Acid bonate, or Sodium Bicarbonate. It contains not
less than 90.0 per cent and not more than 110.0
percent of the labeled amount of ascorbic acid
(C6H8O6).
Packaging and storage—Preserve in light-resistant, single-
dose containers, preferably of T ype I or T ype II glass.
Labeling—In addition to meeting the requirements for Labeling
C6H8O6 176.12 under Injections 〈1〉, fused-seal containers of the Injection in
L-Ascorbic acid [50-81-7]. concentrations of 250 mg per mL and greater are labeled to
indicate that since pressure may develop on long storage, pre-

Official from May 1, 2012

Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.