Download Morphine Sulfate USP Powder

PRODUCT SPECIFICATIONS
CONTROLLED SUBSTANCES
CAS REGISTRY NO.
6211-15-0
Morphine Sulfate USP Powder
FORMULA
(C17H19NO3)2·H2SO4·5H2O
ITEM CODE 1516
MOLECULAR WEIGHT
758.83
APPEARANCE
Fine, white powder, may yellow slightly with age
SOLUBILITY
Clear, colorless to slightly yellow solution
IDENTIFICATION (USP)
(A) IR: Matches standard
(B) Formaldehyde: Purple then to deep blue-violet
(C) Ferric Chloride: Blue to dark red
(D) Sulfate: Meets USP requirements
SPECIFIC ROTATION
(ANHYDROUS BASIS) (USP)
-107o to -109.5o
ACIDITY (USP)
0.50 mL Max
WATER (EQUAL TO USP)
10.4 - 13.4%
RESIDUE ON IGNITION (USP)
0.1% Max
CHLORIDE (USP)
No turbidity
AMONIUM SALTS (USP)
No ammonia odor
LIMIT OF FOREIGN ALKALOIDS (USP)
7.5 mL Min
ORGANIC VOLATILE IMPURITIES
Meets USP requirements
ASSAY (HPLC) (ANHYDROUS BASIS)
(EQUAL TO USP)
98.0 - 102.0% w/w
RELATED SUBSTANCES
Codeine Sulfate: 0.20% area Max
Pseudomorphine: 0.15% area Max
Morphine N-Oxide: 0.15% area Max
Normorphine: 0.15% area Max
10-Hydroxymorphine: 0.15% area Max
Unknown rel. subs. (each): 0.10% area Max
Total rel. subs.: 0.50% area Max
PARTICLE SIZE
d10: NMT 5 micron
d50: NMT 10 micron
d90: NMT 25 micron
SIEVE TEST
No. 100: 99% Min through
ABSORBANCE (400 nm)
0.170 Max
MORPHINE is a phenanthrene-derivative opiate
alkaloid. It is the principal alkaloid of crude opium,
which is a resinous prep of the opium poppy, Papaver
Somniferum. It is present in opium at approximately
10%. Morphine Sulfate is the principal salt of morphine
and a world-wide standard for pain treatment.
Morphine Sulfate is a strong analgesic used to
relieve severe, acute pain or severe, chronic pain
(i.e., in terminally ill patients). The drug is also used
parenterally for preoperative sedation, as a supplement
to anesthesia, and for analgesia during labor. Morphine
is used in patients with acute pulmonary edema for its
cardiovascular effects and to allay anxiety. Morphine
is the drug of choice in relieving pain of myocardial
infarction.
Common Trade Name: Roxanol™, MS Contin®, and
Astramorph®
RESIDUAL SOLVENTS (USP)
Meets USP requirements
DRIPAVINE (EP)
0.20% w/w Max
MORPHINONE (EP)
0.15% w/w Max
The information printed herein is derived from our own laboratories and other sources, and is believed to
be accurate. However, it may be modified by later findings and should be used with this understanding.
Nothing herein shall be construed as a recommendation to use any product in violation of any patent
rights. The user shall have sole responsibility for determination of whether this product is suitable for any
particular purpose. Prior to use, refer to the Material Safety Data Sheet for assistance in determining
safe handling, storage, and use procedures.
Effective 3/2014