Packaging and storage—
Preserve in tight, light-resistant containers. Store at 25
, excursions permitted between 15
and 30
.
Identification—
B: Ultraviolet Absorption 
197U
—
Solution:
100 µg per mL.
Medium:
water.
Absorptivities at 280 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
A solution (1 in 20) responds to the tests for
Chloride 191.
Specific rotation 781S:
between
136
and
139
.
Test solution:
50 mg per mL, in water.
Acidity—
Dissolve 300 mg in 10 mL of water, add 1 drop of
methyl red TS, and titrate with 0.020 N sodium hydroxide VS: not more than 0.30 mL is required to produce a yellow color.
Sulfate—
To a solution of 100 mg in 5 mL of water add 0.5 mL of 3 N hydrochloric acid and 1 mL of
barium chloride TS: no turbidity is produced.
Ordinary impurities 466—
Test solution:
water.
Standard solution:
water.
Eluant:
a mixture of methylene chloride, methanol, and ammonium hydroxide (80:20:1).
Visualization:
3, followed by overspraying with
hydrogen peroxide TS and immediate exposure of the plate to iodine vapors for about 30 minutes.
Organic volatile impurities, Method I 467:
meets the requirements.
Assay—
Transfer about 225 mg of Hydromorphone Hydrochloride, previously dried and accurately weighed, to a 250-mL conical flask, and dissolve in 80 mL of glacial acetic acid, warming, if necessary. Cool, and add 5 mL of acetic anhydride and 10 mL of
mercuric acetate TS. Add 1 drop of
crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 32.18 mg of C
17H
19NO
3·HCl.
Auxiliary Information—
Staff Liaison :
Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1081
Pharmacopeial Forum : Volume No. 30(4) Page 1254
Phone Number : 1-301-816-8139
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)-.