Molecular Weight : 201.69
CAS No. : 345-78-8
1. (1S,2S)-2-Methylamino-1-phenyl propan-1-ol, Hydrochloride
2. Benzenemethanol, a-[1-(methylamino)ethyl]-, [S-(R*,R*)],
HYDROCHLORIDE;PSEUDOEPHEDRINE HCL;PSEUDOEPHEDRINE HCL,
||Fine, white to
off white crystals or powder.
||a ) Infrared
spectrum of sample is concordant with the
b) A solution of sample responds to the test for chloride
||Between 182° and
186°C; the range between beginning
and end of melting does not exceed 2°C
||Between + 61.0°
and + 62.5° (5 % solution in water)
||Very soluble in
water and freely soluble in alcohol.
||Between 4.6 and
6.0 (5 % solution in water)
||NMT 2.0 %
||NMT 0.1 %
||NMT 0.5 %
volatile impurities :
||Must pass the test
||Between 98.0 % and 100.5 % (
dried basis )
Therapeutic indications : Decongestant Packing :
Packed in double lined polyethylene bags in 25 kg fiber drums.
Storage : Store below 35°C.
Pseudoephedrine is a
sympathomimetic amine commonly used as a decongestant. The salts
pseudoephedrine hydrochloride and pseudoephedrine sulfate are found in
many over-the-counter preparations either as single-ingredient
preparations, or more commonly in combination with antihistamines,
paracetamol (acetaminophen) and/or ibuprofen. Sudafed is a trademark for
a common brand which contains pseudoephedrine hydrochloride, though
Sudafed PE does not. Cirrus contains pseudoephedrine in conjunction with
cetirizine (an antihistamine).
Unlike antihistamines, which relieve multiple allergic symptoms by
acting as antagonists at histamine receptors, pseudoephedrine primarily
relieves nasal congestion commonly associated with colds or allergies.
The advantage of oral pseudoephedrine over topical nasal preparations,
such as oxymetazoline, is that it does not cause rebound congestion
(rhinitis medicamentosa); however, it is more likely to cause adverse
effects including hypertension.
Pseudoephedrine is being phased out as an over-the-counter drug in some
countries and replaced by less effective.
Pseudoephedrine is a phenethylamine, and a diastereomer of ephedrine.
Pseudoephedrine is a chiral molecule, meaning it occurs in both
"left-handed" and "right-handed" configurations which are not
Pseudoephedrine is the International Nonproprietary Name (INN) of the
(1S,2S)- diastereomer of ephedrine (which has 1R,2S- configuration).
Other names are (+)-pseudoephedrine and D-pseudoephedrine.
L-Pseudoephedrine, also known as (-)-(1R,2R)-pseudoephedrine or (-)-pseudoephedrine,
is the optical isomer of D-pseudoephedrine. It has fewer side-effects,
fewer central nervous system (CNS) stimulatory effects, does not reduce
to D-methamphetamine (which is the enantiomer used as a recreational
drug), and yet it retains its efficacy as a decongestant.[citation
needed] However, the patent holder for L-pseudoephedrine (Pfizer/Warner-Lambert)[has
not yet sought or received government approval for its sale to the
Pseudoephedrine is indicated for the treatment of:
* nasal congestion
* sinus congestion
* Eustachian tube congestion.
Pseudoephedrine is also indicated for vasomotor rhinitis, and as an
adjunct to other agents in the optimum treatment of allergic rhinitis,
croup, sinusitis, otitis media, and tracheobronchitis.
Common adverse drug reactions (ADRs) associated with pseudoephedrine
therapy include: CNS stimulation, sleeplessness, nervousness,
excitability, dizziness and anxiety. Infrequent ADRs include:
tachycardia and/or palpitations. Rarely, pseudoephedrine therapy may be
associated with hallucinations, arrhythmias, hypertension, seizures and
ischemic colitis;as well as severe skin reactions known as recurrent
pseudo-scarlatina, systemic contact dermatitis, and nonpigmenting fixed
drug eruption.Pseudoephedrine, particularly in high doses, may also
cause episodes of paranoid psychosis.It has also been reported that
pseudoephedrine, amongst other sympathomimetic agents, may be associated
with the occurrence of stroke.
These API/ chemicals are designated as
those that are used in the manufacture of the controlled substances and
are important to the manufacture of the substances. For any (Control
Substance) products Import and Export *** subjected to your country
government laws /control substance ACT.
Note /Government Notification:
These chemicals are designated as those that are used in the manufacture
of the controlled substances and are important to the manufacture of the
substances. For any (Control Substance) products Import and Export ***
subjected to your country government laws /control substance ACT.
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