Stability of Caffeine Injection in Intravenous Admixtures and Parenteral Nutrition Solutions

DICP ◽  
1989 ◽  
Vol 23 (6) ◽  
pp. 466-467 ◽  
Author(s):  
Milap C. Nahata ◽  
Josephine R. Zingarelli ◽  
Diane E. Durrell
Keyword(s):  
Amino Acids ◽  
Parenteral Nutrition ◽  
Potassium Chloride ◽  
Room Temperature ◽  
Hplc Method ◽  
Final Concentration ◽  
Stability Indicating ◽  
The Stability

Our objective was to determine the stability of caffeine base in intravenous admixtures and parenteral nutrition solutions at room temperature for 24 hours. Caffeine 10 mg/mL was used in this study. The admixtures included D5W; D5W with NaCl 0.2% injection; D5W with NaCl 0.2% and 20 mEq/L of potassium chloride injection; D10W injection; and D10W with NaCl 0.2% and 5 mEq/L of KCl injection. The parenteral nutrition solutions included 1.1% amino acids with electrolytes; 2.2% amino acids with electrolytes; and 4.25% amino acids with electrolytes. These parenteral nutrition solutions were prepared in D10W. Ten milliliters of caffeine were added to glass test tubes containing 10 mL of various solutions to yield a final concentration of 5 mg/mL. One milliliter aliquots were removed at 0, 2, 4, 8, and 24 hours and caffeine was measured by a stability-indicating HPLC method. The largest change in the concentrations of caffeine was 4.1 percent during the study period. Thus, caffeine injection is stable in various admixtures and parenteral nutrition solutions at room temperature for 24 hours.

Stability of Tacrolimus Injection in Total Parenteral Nutrition Solution

1996 ◽  
Vol 12 (2) ◽  
pp. 58-61
Author(s):  
Yi-Min Ku ◽  
David I Min ◽  
Vijay Kumar ◽  
Saleem A Noormohamed
Keyword(s):  
Amino Acids ◽  
Parenteral Nutrition ◽  
Continuous Infusion ◽  
Total Parenteral Nutrition ◽  
Room Temperature ◽  
Color Change ◽  
Storage Conditions ◽  
Black Background ◽  
Lighting Conditions ◽  
The Stability

Objective: To examine the stability of tacrolimus in a total parenteral nutrition (TPN) solution over 24 hours at room temperature. Study Method: Admixtures of tacrolimus 0.1 mg/mL in TPN, containing amino acids 4.25%, dextrose 25%, and electrolytes, were prepared and visually inspected under normal lighting conditions against a white and black background for color change, turbidity, cloudiness, and precipitation. The concentration of tacrolimus in the admixtures was determined by HPLC at 0, 1, 2, 4, 8, 12, and 24 hours after preparation. Results: The concentration of tacrolimus did not change over the 24-hour study period. No color change, precipitation, or cloudiness was observed in any of the solutions under the storage conditions. Conclusions: Tacrolimus is chemically stable in TPN for 24 hours at room temperature, and therefore can be administered to patients as a 24-hour continuous infusion with TPN.

Stability of a pyrimethamine suspension compounded from bulk powder

2017 ◽  
Vol 74 (24) ◽  
pp. 2060-2064 ◽  
Author(s):  
Paul O. Lewis ◽  
David B. Cluck ◽  
Jessica D. Huffman ◽  
Amanda P. Ogle ◽  
Stacy D. Brown
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Stability Indicating ◽  
Color Changes ◽  
Stability Indicating Method ◽  
Bulk Powder ◽  
Subsequent Application ◽  
Temperature Ranges ◽  
The Stability

Abstract Purpose Development of a stability-indicating high-performance liquid chromatography (HPLC) method for pyrimethamine analysis, with subsequent application of that method to assess the 90-day stability of a pyrimethamine suspension compounded from bulk USP-grade pyrimethamine powder, is described. Methods A stability-indicating method of HPLC with ultraviolet detection specific to pyrimethamine was developed according to pharmacopeial recommendations and validated. The method was applied to investigate the stability of a 2-mg/mL pyrimethamine suspension in a vehicle consisting of Ora-Plus and Ora-Sweet (Perrigo) over a period of 90 days. Three replicate test preparations were stored at room temperature or refrigerated at 4.3–5.2 °C, and samples were analyzed in duplicate immediately after preparation and on study days 1, 2, 4, 7, 10, 14, 21, 30, 48, 60, 75, and 90. Results The 2-mg/mL suspension of pyrimethamine in Ora-Plus and Ora-Sweet retained 90–110% of the labeled potency to 90 days at both temperature ranges. However, color changes in the samples stored at room temperature observed at day 60 indicated that a beyond-use date less than 90 days from the preparation date should be specified when the suspension is to be stored at room temperature. Conclusion The study demonstrated that USP-grade pyrimethamine powder can be formulated as a 2-mg/mL suspension in a vehicle of Ora-Plus and Ora-Sweet and is stable when stored at room temperature and when refrigerated, in amber plastic bottles, for 48 and 90 days, respectively.

scholarly journals Stability of extemporaneously compounded amiloride nasal spray

2020 ◽  
Author(s):  
Venkata Yellepeddi ◽  
Casey Sayre ◽  
Anna Burrows ◽  
Kevin Watt ◽  
Simon Davies ◽  
...  
Keyword(s):  
United States ◽  
Nasal Spray ◽  
Room Temperature ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Indicating ◽  
Spray Solution ◽  
Microbiological Stability ◽  
The Stability ◽  
Amiloride Hydrochloride

AbstractAnxiety disorders (AD) are the most common mental illnesses affecting an estimated 40 million adults in the United States. Amiloride, a diuretic agent, has shown efficacy in treating AD in preclinical models by inhibiting the acid-sensing ion channels (ASIC). By delivering amiloride via nasal route, rapid onset of action can be achieved due to direct “nose-to-brain” access. Therefore, this study reports the formulation, physical, chemical, and microbiological stability of an extemporaneously prepared amiloride 2 mg/mL nasal spray. The amiloride nasal spray was prepared by adding 100 mg of amiloride hydrochloride to 50 mL of sterile water for injection in a sterile reagent bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated. Forced-degradation studies were performed to confirm the ability of the HPLC method to identify the degradation products from amiloride distinctively. The physical stability of the amiloride nasal spray was assessed by pH, clarity, and viscosity assessments. For chemical stability studies, samples of nasal sprays stored at room temperature were collected at time-points 0, 3 hr., 24 hr., and 7 days and were assayed in triplicate using the stability-indicating HPLC method. Microbiological stability of the nasal spray solution was evaluated for up to 7 days based on the sterility test outlined in United States Pharmacopoeia (USP) chapter 71. The stability-indicting HPLC method identified the degradation products of amiloride without interference from amiloride. All tested solutions retained over 90% of the initial amiloride concentration for the 7-day study period. There were no changes in color, pH, and viscosity in any sample. The nasal spray solutions were sterile for up to 7 days in all samples tested. An extemporaneously prepared nasal spray solution of amiloride hydrochloride (2 mg/mL) was physically, chemically, and microbiologically stable for 7 days when stored at room temperature.

Stability-indicating HPLC method to determine the stability of extemporaneously prepared vancomycin oral solution cups

2021 ◽  
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Gagan Kaushal
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Oral Solution ◽  
Hplc Assay ◽  
Stability Indicating ◽  
Oral Formulations ◽  
Unit Dose ◽  
The Stability

Abstract Purpose To determine the stability of compounded sweetened vancomycin oral formulations in plastic unit dose cups stored up to 180 days under 2 temperature conditions: refrigeration (2°C-6°C) and room temperature (25°C with 60% relative humidity). Methodology A stability-indicating high-performance liquid chromatography (HPLC) method was developed to analyze vancomycin in the presence of degradation peaks. The stability of extemporaneously compounded vancomycin solution stored in oral unit dose cups was investigated using this method. The tested vancomycin oral solutions were compounded formulations of 125 mg/2.5 mL and 500 mg/10 mL. Three oral unit dose cups from each storage condition were withdrawn and assessed for stability on days 0, 3, 7, 15, 22, 30, 90, 120, 150, and 180 as per United States Pharmacopeia guidelines. The assay of vancomycin was carried out by using a calibrated stability-indicating HPLC method. Results The stability-indicating HPLC assay showed that vancomycin completely degraded within 2 hours when exposed to highly acidic or basic pH conditions. No precipitation, cloudiness, or color changes were observed during the study under either temperature condition. The HPLC assay revealed that vancomycin oral solution cups retained greater than 90% of the initial concentrations of vancomycin for 30 days when stored at room temperature (25°C and 60% relative humidity) and for 180 days with refrigeration (2°C-6°C). Conclusion Vancomycin oral formulations were stable for long-term storage periods beyond those specified in manufacture guidelines. Our data suggests the extended stability of vancomycin oral solutions compounded for hospital use can be extended.

scholarly journals SIMULTANEOUS ESTIMATION, VALIDATION, AND FORCED DEGRADATION STUDIES OF BETAHISTINE DIHYDROCHLORIDE AND DOMPERIDONE IN A PHARMACEUTICAL DOSAGE FORM USING RP-HPLC METHOD

2018 ◽  
Vol 11 (10) ◽  
pp. 125
Author(s):  
Vaishali Mistry ◽  
Rohan Mishra
Keyword(s):  
Hplc Method ◽  
Base Hydrolysis ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Betahistine Dihydrochloride ◽  
The Stability

Objective: This study describes the stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of betahistine dihydrochloride and domperidone in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic operation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 80:20% v/v and eluents were scanned using a UV detector at 244 nm.Results: The retention time of betahistine dihydrochloride and domperidone was found to be 2.3 and 3.6 min, respectively. A linearity response was observed in the concentration range of 9.6 μg/ml–22.4 μg/ml for betahistine dihydrochloride and 6–14 μg/ml for domperidone, respectively. Limit of detection and limit of quantification for betahistine dihydrochloride were 0.52 μg/ml and 1.58 μg/ml and for domperidone are 0.64 μg/ml and 1.94 μg/ml, respectively.Conclusion: The stability-indicating method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.

Stability of Ceftazidime and Vancomycin Alone and in Combination in Heparinized and Nonheparinized Peritoneal Dialysis Solution

1994 ◽  
Vol 28 (5) ◽  
pp. 572-576 ◽  
Author(s):  
Leigh M. Vaughan ◽  
Cathy Y. Poon
Keyword(s):  
Peritoneal Dialysis ◽  
Room Temperature ◽  
Color Change ◽  
Hplc Assay ◽  
Time Points ◽  
Stability Indicating ◽  
Dialysis Solution ◽  
Peritoneal Dialysis Solution ◽  
The Stability

OBJECTIVE: To examine the stability of ceftazidime, vancomycin, and heparin, alone and in combination, in dialysis solution over six days at three temperatures. DESIGN: Nine 250-mL Dianeal PD-2 dextrose 1.5% bags were prepared with ceftazidime, vancomycin, and heparin alone and in combination at set concentrations of 100 μg/mL, 50 μg/mL, and 1 unit/mL, respectively. Three bags of each mixture were stored at 4, 25, and 37°C. Duplicate samples for analysis were removed from each bag at the following time points: premix, 0, 12, 24, 48, 72, 96, 120, and 144 hours. MAIN OURCOME MEASURES: Each sample was examined visually for signs of cloudiness and precipitation. Each sample was analyzed by stability-indicating HPLC assay for ceftazidime and vancomycin, with stability defined as less than 10 percent degradation of drug overtime. RESULTS: No color change or precipitation was observed in any bag. Vancomycin with or without heparin was stable for 5–6 days at 4, 25, and 37°C. Ceftazidime with and without heparin was stable for 6 days at 4°C, 4 days at 25°C, and less than 12 hours at 37 °C. Vancomycin plus ceftazidime with and without heparin was stable for 6 days at 4 °C and 25°C, and 4–5 days at 37 °C, Ceftazidime plus vancomycin with or without heparin was stable for 6 days at 4°C, 2–3 days at 25°C, and 12 hours at 37 °C. CONCLUSIONS: Bulk preparations of ceftazidime and vancomycin, alone and in combination and with or without heparin in Dianeal PD dextrose 1.5% solution, are sufficiently stable for use up to 6 days under refrigeration or 48 hours at room temperature.

scholarly journals The influence of pH and temperature on the stability of flutamide. An HPLC investigation and identification of the degradation product by EI+-MS

RSC Advances ◽  
2015 ◽  
Vol 5 (5) ◽  
pp. 3206-3214 ◽  
Author(s):  
R. N. El-Shaheny ◽  
K. Yamada
Keyword(s):  
Degradation Product ◽  
Degradation Kinetics ◽  
Hplc Method ◽  
Profile Curve ◽  
Arrhenius Plots ◽  
Stability Indicating ◽  
The Stability ◽  
Rate Profile ◽  
Influence Of Ph

Stability of flutamide was investigated using validated stability-indicating HPLC method. Degradation kinetics, Arrhenius plots, and pH-rate profile curve were explored.

scholarly journals Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome

2021 ◽  
Vol 26 (4) ◽  
pp. 395-404
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Walter Kraft ◽  
Gagan Kaushal
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Condition ◽  
Stability Study ◽  
Neonatal Abstinence Syndrome ◽  
Limited Information ◽  
Abstinence Syndrome ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C–8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days. RESULTS Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days. CONCLUSIONS Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.

scholarly journals Evaluation of degradation kinetics for abamectin in formulations using a stability indicating method

2013 ◽  
Vol 63 (1) ◽  
pp. 59-69 ◽  
Author(s):  
Atul Awasthi ◽  
Majid Razzak ◽  
Raida Al-Kassas ◽  
Joanne Harvey ◽  
Sanjay Garg
Keyword(s):  
Degradation Kinetics ◽  
Hplc Method ◽  
Degradation Behavior ◽  
Ph Change ◽  
Stability Indicating ◽  
First Order ◽  
Stability Indicating Method ◽  
First Order Kinetics ◽  
Maximum Stability ◽  
The Stability

The aim of this study was to evaluate stability characteristics and kinetics behavior of abamectin (ABM) as a 1 % (m/V) topical veterinary solution. During the study, samples stressed at 55 and 70 °C were regularly analyzed for several parameters over 8 weeks on a chromatographic (HPLC) system, using a Prodigy C18, 250 x 4.6 mm, 5-μm, column eluting with 15 : 34 : 51 (V/V/V) water/methanol/ acetonitrile as mobile phase. The HPLC method was validated for precision, accuracy, linearity and specificity, and was found to be stability indicating. The results showed that degradation of ABM followed first-order kinetics and data on loss in kobs (s-1) and half life (t1/2, days) demonstrated ABM showing the maximum stability in glycerol formal. The degradation behavior of ABM varies from solvent to solvent. The effect of added alkali on pH change and loss of ABM was studied and found to be unique for all solvents and very distinct from typical hydrolysis degradation. The present study may serve as a platform to design and develop topical non-aqueous solutions of ABM for veterinary use given no such comprehensive efforts have been published to date on the stability profile of ABM in non-aqueous solvents.

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