Hydrochloride Syrup

Hydrolysis of D-(+)-1 (3-methoxyphenyl)-2-aminopropane 2.42 mols (40 g) of the compound are dissolved In 8N hydrochloric acid in a bomb tube consisting of stainless steel and having a capacity of 500 ml. Hydrogen chloride gas is passed into the ice-cooled solution until this is saturated. The solution is then heated to 130°C for 2 hours in an air bath. After cooling and driving off the hydrochloric acid at a slightly elevated temperature, the hydrochloride of the 3-hydroxyphenyl derivative is present in the form of a yellowish syrup. 

Pipethanate hydrochloride Is dissolved in water and the solution is made alkaline by adding 10% sodium hydroxide solution. The crystals that are separated are filtered off and recrystallized from dilute ethanol. The monohydrate thereby obtained is dehydrated at 100°C under reduced pressure for 20 minutes. The products that are now in the form of a syrup due to loss of water of crystallization are further dehydrated for 2 days in a desiccator over phosphorus pentoxide whereupon the anhydrous pipethanate is obtained. 

Other drugs in combination with a sweetening agent were also studied, dextromethorphan hydrobromide [21], doxycycline hydrochloride [21], erythromycin [23], chloramphenicol [23], ampicillin [23] and cefpodoxime proxetil [23] as bitter drugs and simple syrup (2.5M sucrose solution, used as a flavoring agent prescribed by The Japanese... 

Pseudoephedrine hydrochloride can be considered a stable compound in bulk and in formulations. After 4-weeks under fluorescent lights (2400 ft. candles) and ultraviolet light (190 pw/cm2) no discoloration or chemical degradation was observed. The bulk drug was stable for at least 6 months at 37°C and 3 months at 50°C. Tablet and syrup formulations stored at 15-30°C for 5 years showed no appreciable degradation. 13... 

An ultraviolet spectrophotometric method based on the absorbance of a periodate oxidation product of pseudoephedrine hydrochloride will be the official method of analysis in the USP XX.19,20 A portion of tablets or syrup in water is placed in a separatory funnel. Sodium bicarbonate and sodium metaperiodate are added. After standing for 15 minutes, 1 N HC1 is added. The solution is extracted with hexane. The hexane extract is filtered and its absorbance determined at 242 nm in 1 cm cells. The amount of the oxidation product of pseudoephedrine hydrochloride is determined by comparison of the sample absorbance against the absorbance of a Pseudoephedrine Hydrochloride Reference Standard treated in the same manner. 

Pseudoephedrine hydrochloride in syrup formulations has been analyzed by colorimetry. Pseudoephedrine forms a stable blue-colored chelate with cupric sulfate at pH 12.5. The complex has a maximum absorbance at 500 nm. The complex is extracted from an aqueous layer with 1-pentanol. Interfering substances such as glycerine and sugars normally found in syrup formulations, which form complexes with cupric sulfate, are not extracted into 1-pentanol.21... 

Ultraviolet light will convert the E-form of triprolidine hydrochloride to the Z-form. After 2 years at 37°C, triprolidine hydrochloride in a syrup formulation does not decompose more than 10%. After 3 years at 37°C triprolidine hydrochloride in tablet formulations does not decompose more than 10%. The formulations are kept in light resistant containers since triprolidine hydrochloride discolors on exposure to light.9... 

The plasma levels of triprolidine hydrochloride were determined in 16 normal male subjects.12 When administered orally at a concentration of 3.75 mg triprolidine hydrochloride in 15 ml of syrup, peak plasma levels of 8.2 ng/ml were achieved in 2 hours with a drug half-life of 5 hours. The low plasma levels found indicate a large volume of tissue distribution which was consistent with data obtained from rat studies. 

Triprolidine hydrochloride in syrups and tablets can be analyzed by fluorimetry. A portion of the tablets or syrup is made basic with IN NaOH and extracted with ethylene chloride. The organic phase is then extracted with 0.1N I SO. The fluorescence of the acid extract is determined with a fluorometer using a UG11 filter for excitation and a Wratten 2A filter for emission. The fluorescence of the sample preparation is compared against a Reference Standard prepared in the same manner22. 

The obtained results indicated that this procedure could be applied for the determination of ibuprofen, pseudoephedrine hydrochloride, chlorpheniramine maleate and nipagen in syrup preparations. 

The mother liquor contains too little DL-aspartic acid to justify its recovery. When the filtrate and washings are evaporated to a syrup and treated with 500 ml. of 95% ethanol, the pyridine hydrochloride dissolves completely, leaving 8-9 g. of crude glycine which yields little or no sparingly soluble DL-aspartic acid on treatment with a minimum quantity of cold water. 

CLARINEX (Sobering) (desloratadine) tablets, syrup. Reditabs tablets August 2004 labeling COVERA-HS (Searle) (verapamil hydrochloride) extended-release tablets July 2003 labeling... 

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