Stability and Compatibility of Cimetidine Hydrochloride and Aminophylline in Dextrose 5% in Water Injection

1988 ◽  
Vol 22 (7-8) ◽  
pp. 592-593 ◽  
Author(s):  
Richard J. Baptista ◽  
Francis P. Mitrano
Keyword(s):  
Chemical Stability ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Water Injection ◽  
Controlled Study ◽  
Time Interval ◽  
Direct Sunlight ◽  
Control Solution ◽  
And Control

A controlled study was conducted to assess the physical compatibility of cimetidine hydrochloride (HCl) and aminophylline and the chemical stability of an admixture of the two medications in dextrose 5% in water (D5W) injection, over 48 hours at room temperature. Three one-liter admixtures were prepared, each containing cimetidine HCl 1200 mg and aminophylline 500 mg in D5W. One liter of only cimetidine HCl 1200 mg in D5W and one liter of only aminophylline 500 mg in D5W served as controls. Samples drawn from the five admixtures and immediately frozen were analyzed for cimetidine and theophylline content at times 0, 1, 6, 24, and 48 hours using high-performance liquid chromatography. Chemical stability of each drug was assessed relative to its time-zero concentration. Samples were also drawn from each test and control solution at every time interval to assess the pH. Admixtures were stored at room temperature out of direct sunlight for the duration of the study, and were visually inspected for color change, turbidity, cloudiness, and precipitation. Recovery of cimetidine and theophylline at all test intervals, pH assessments, and visual inspections of the admixtures showed that cimetidine HCl and aminophylline are both chemically stable and physically compatible for 48 hours at room temperature in one liter of D5W.

Stability of Tobramycin and Ceftazidime in Icodextrin Peritoneal Dialysis Solution

2009 ◽  
Vol 29 (1) ◽  
pp. 52-57 ◽  
Author(s):  
Katie E. Pallotta ◽  
Rowland J. Elwell ◽  
Adwoa O. Nornoo ◽  
Harold J. Manley
Keyword(s):  
Peritoneal Dialysis ◽  
Body Temperature ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Sampling Interval ◽  
Initial Concentration ◽  
Dialysis Solution ◽  
All Solutions ◽  
Peritoneal Dialysis Solution

Purpose The data describing the compatibility of tobramycin and ceftazidime in icodextrin-based peritoneal dialysis (PD) solution is limited. The objective of this study was to assess the chemical stability of tobramycin and ceftazidime in icodextrin PD solution in polyvinyl chloride containers. Methods Commercially available 2-L bags of icodextrin 7.5% PD solution were used for each sample. Nine tobramycin study samples were prepared by adding 80 mg tobramycin HCl to each bag. Nine ceftazidime samples were prepared by adding 1000 mg ceftazidime to each bag. Three bags of tobramycin–icodextrin solution were stored under each of the following conditions: refrigeration (4°C), room temperature (25°C), and body temperature (37°C). Three bags of ceftazidime–icodextrin solution were also stored at each of the respective temperatures. Samples were withdrawn from each bag immediately after preparation and at predetermined intervals (1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, and 336 hours after preparation). Solutions were visually inspected for precipitation, cloudiness, and discoloration at each sampling interval. All samples were immediately frozen (–80°C) after collection and stored prior to assay. Total concentrations of tobramycin and ceftazidime in dialysate fluid were determined by high-performance liquid chromatography. The last time point when tobramycin or ceftazidime concentration was >90% from baseline was used to denote stability. Results All solutions were clear in appearance and no color change or precipitation was observed during the study. For tobramycin, under refrigeration, a mean of 94.6% ± 2.3% of the initial concentration remained at 336 hours (14 days); at room temperature, 90.5% ± 4.3% remained at 168 hours (7 days); at body temperature, 90.0% ± 8.1% remained at 24 hours. For ceftazidime, under refrigeration, a mean of 98.0% ± 0.3% of the initial concentration remained at 168 hours (7 days); at room temperature, 91.6% ± 2.0% remained at 48 hours; at body temperature, 93.9% ± 1.1% remained at 8 hours. Stability was not assessed beyond these respective time points. Conclusion Premixed tobramycin–icodextrin PD solution remains stable for 336 hours (14 days) when refrigerated (4°C) and for 168 hours (7 days) at room temperature (25°C). Ceftazidime–icodextrin PD solution is stable for 168 hours and 48 hours, respectively, when stored at 4°C and 25°C. It is recommended that the bags be kept refrigerated whenever possible. Tobramycin–icodextrin solution stored at body temperature was stable up to 24 hours, and ceftazidime–icodextrin solutions up to 8 hours, permitting the practice of pre-warming solutions prior to administration.

Multitemperature Stability and Degradation Characteristics of Pergolide Mesylate Oral Liquid

2010 ◽  
Vol 23 (6) ◽  
pp. 570-574 ◽  
Author(s):  
Brandon R. Shank ◽  
Clyde M. Ofner
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Degradation Process ◽  
First Order ◽  
Drug Concentrations ◽  
Relative Standard ◽  
Oral Liquid ◽  
The Stability ◽  
Initial Drug

The stability of pergolide mesylate in an oral aqueous liquid was studied. Stability and solubility data were used to determine the degradation characteristics of the drug in this formulation. Samples were stored in the dark at 35°C, 45°C, and 60°C. At 1, 2, 4, 8, 12, and 16 weeks, samples were removed and stored in a −80°C freezer for high performance liquid chromatography (HPLC) assay at a later date. The initial drug concentration of 0.30 mg/mL was determined by assay after storage at −80°C. A solubility of 6.9 mg/mL was found for pergolide mesylate in the oral liquid at room temperature with a relative standard deviation (RSD) of 4.0%. The degradation process is considered first-order at 25°C and 35°C. At higher temperatures (45°C and 60°C), a color change and curvature at the latter time points in degradation profiles are ascribed to the presence of methylcellulose. The activation energy calculated for degradation of pergolide mesylate in the oral liquid was 21.3 kcal/mol. The time to reach 90% potency (t90) values were calculated to be 43 days and 3 days, respectively, for storage at 25°C and 35°C. Drug concentrations up to ~6 mg/mL can be maintained as a solution at room temperature with this formulation.

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 Long-Term Stability of Lorazepam in Sodium Chloride 0.9% Stored at Different Temperatures in Different Containers

2019 ◽  
Vol 55 (3) ◽  
pp. 188-192
Author(s):  
M. L. Colsoul ◽  
A. Breuer ◽  
N. Goderniaux ◽  
J. D. Hecq ◽  
L. Soumoy ◽  
...  
Keyword(s):  
Time Management ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Period ◽  
Term Stability ◽  
Long Term Stability ◽  
Glass Bottles ◽  
The Stability

Background and Objective: Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Method: Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Results: Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Conclusion: Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.

scholarly journals PHYSICAL AND CHEMICAL STABILITY TEST OF NEEM OIL CREAM (AZADIRACHTA INDICA) USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2021 ◽  
pp. 128-134
Author(s):  
FEBRINA AMELIA SAPUTRI ◽  
PATIHUL HUSNI ◽  
NORISCA ALIZA PUTRIANA
Keyword(s):  
Chemical Stability ◽  
High Performance ◽  
Room Temperature ◽  
Packed Column ◽  
Physical Stability ◽  
Hplc Method ◽  
Neem Oil ◽  
Isocratic Elution ◽  
Validation Parameters ◽  
Physical And Chemical

Objective: This study aims to examine the physical and chemical stability of neem oil cream. Methods: Physical stability was conducted by storing the cream at room temperature (25±2 °C/65 %RH±5 %RH) and high temperature (40±2 °C/75 % RH±5 % RH) for 3 mo. HPLC method using Dionex with UV detection at 219 nm, Shodex (C-18) HPLC packed column (4.6 mmID x 250 mmL), acetonitrile: water [30:70] as mobile phase, 10 min isocratic elution with a flow rate of 1.0 ml/min with volume injection 20 μL was validated then was carried out to measure azadirachtin levels in neem oil cream. The chemical stability of azadirachtin in the cream was determined for 90 days by using this validated method. Results: The neem oil cream was physically stable. The HPLC method of azadirachtin meets all the validation parameters and can be used to analyze the chemical stability of azadirachtin in neem oil cream. Neem oil cream was stable for 4 w at 25 °C and for 1 w at 40 °C. Conclusion: The neem oil cream was either physically or chemically stable for 4 weeks at 25 oC and 1 week at 40 oC

scholarly journals Efficacy of Chlorine Dioxide as a Gas and in Solution in the Inactivation of Two Trichothecene Mycotoxins

2005 ◽  
Vol 24 (3) ◽  
pp. 181-186 ◽  
Author(s):  
S. C. Wilson ◽  
T. L. Brasel ◽  
J. M. Martin ◽  
C. Wu ◽  
L. Andriychuk ◽  
...  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Chlorine Dioxide ◽  
Kluyveromyces Marxianus ◽  
High Performance ◽  
Room Temperature ◽  
Detectable Effect ◽  
Yeast Assay ◽  
And Control ◽  
Ppm Level

The efficacy of chlorine dioxide (ClO2) in detoxifying two potential bioterrorism agents, the trichothecene mycotoxins verrucarin A and roridin A, was evaluated. In the first experiment, verrucarin A (1, 5, or 10 μg) and roridin A (5 or 10 μg) were each inoculated onto square-inch sections of glass, paper, and cloth and exposed to 1000 ppm of ClO2 for either 24 or 72 h at room temperature. In the second experiment, verrucarin A and roridin A (1 or 2 ppm in water) were treated with 200, 500, or 1000 ppm ClO2 for up to 116 h at room temperature in light and dark conditions ( N = 9 per treatment for test and control). A yeast assay using Kluyveromyces marxianus was used to quantify the toxicity of verrucarin A and roridin A. Additionally, high-performance liquid chromatography was performed on selected samples. Results for the first experiment showed that ClO2 treatment had no detectable effect on either toxin. For the second experiment, both toxins were completely inactivated at all tested concentrations in as little as 2 h after treatment with 1000 ppm ClO2. For verrucarin A, an effect was seen at the 500 ppm level, but this effect was not as strong as that observed at the 1000 ppm level. Roridin A toxicity was decreased after treatment with 200 and 500 ppm ClO2, but this was not significant until the 24-h exposure time was reached. These data show that ClO2 (in solution) can be effective for detoxification of roridin A or verrucarin A at selected concentrations and exposure times.

Stability of Furosemide in Human Albumin Solution

2002 ◽  
Vol 36 (3) ◽  
pp. 423-426 ◽  
Author(s):  
Rowland J Elwell ◽  
Anne P Spencer ◽  
Julie F Barnes ◽  
James E Wynn ◽  
Curtis E Jones
Keyword(s):  
Chemical Stability ◽  
Room Temperature ◽  
Color Change ◽  
Fungal Growth ◽  
Human Albumin ◽  
Bulk Solution ◽  
Molar Ratio ◽  
Albumin Solution ◽  
Time Points ◽  
Human Albumin Solution

OBJECTIVE: To determine the chemical stability of furosemide in human albumin solution over a 28-day period and to assess admixtures for microbiologic contamination. METHODS: Samples were prepared by mixing furosemide injectable solution and 25% human albumin solution in a 1:1 molar ratio. Six bulk containers were prepared and stored in the dark: 3 under refrigeration (∼4 °C) and 3 at room temperature (∼25 °C). Study samples were withdrawn from each bulk solution immediately after preparation and at predetermined intervals over the subsequent 28 days. Containers were observed for color change and precipitation against a light and dark background at each sampling interval. Total furosemide concentration was determined using HPLC. Additional vials were prepared and assessed for microbiologic growth at time points corresponding with chemical stability results. RESULTS: A mean of 94.5% ± 1.33% of the initial furosemide concentration remained after 48 hours at room temperature. Under refrigeration, 100.6% ± 1.02% of the initial concentration remained at 14 days. Beyond these respective time points, <90% of the initial furosemide concentration remained. No bacterial or fungal growth was observed. CONCLUSIONS: When combined with 25% human albumin solution and stored under darkness, furosemide is chemically stable and free of microbiologic contamination for 48 hours at room temperature and 14 days under refrigeration.

scholarly journals Cooled (4ºC) lidocaine during office cystoscopy improves patient satisfaction and comfort: A prospective, randomized, double-blind, controlled study

2021 ◽  
Vol 15 (9) ◽  
Author(s):  
Sanjay Razdan ◽  
Rajesh Bajpai ◽  
Shirin Razdan ◽  
Marcos Sanchez-Gonzalez
Keyword(s):  
Pain Score ◽  
Room Temperature ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Subjective Pain ◽  
Pain Reporting ◽  
Male Patients ◽  
And Control

Introduction: Office-based flexible cystoscopy is often associated with considerable discomfort in male patients. We devised this study to prospectively evaluate the efficacy of cooling intraurethral lidocaine jelly to 4ºC prior to use in office-based cystoscopy in an effort to reduce male patient discomfort. Methods: A total of 600 male patients scheduled for office diagnostic cystoscopy were enrolled and randomized into three groups for a prospectively controlled, double-blind study. Each group received one of the three methods of intraurethral lubrication: plain room temperature lubricant (control) (CON), room temperature lidocaine (LI), or lidocaine at 4ºC (LI4ºC). Perceived pain was recorded on a Likert visual analog scale (VAS) of 1–10 where 0=no pain and 10=excruciating pain. Kruskal-Wallis test assessed the efficacy of cooling lidocaine compared to room temperature lidocaine and control. Subjective pain reporting was corroborated with instantaneous objective pulse rate recording eliminating perception bias. Results: There was no significant difference in cystoscopy duration between all groups. Mean pain scores (mean ± standard deviation) were 4.05±0.91, 2.74±1.01, and 1.8±0.84, respectively, for groups CON, LI, and LI4ºC (p=0.02). There was a 32.34% reduction in the mean pain score of LI and a further reduction of 34.3% was achieved in LI4ºC when compared to CON. Body mass index (BMI) and prostate weight had a significant positive correlation with pain score, whereas no such correlation was found with age. Conclusions: Cooling lidocaine to 4ºC provides additional analgesic benefit in men undergoing office cystoscopy and increases compliance.

scholarly journals Chemical Stability of Extemporaneously Prepared Lorazepam Suspension at Two Temperatures

2004 ◽  
Vol 9 (4) ◽  
pp. 254-258
Author(s):  
Wan-Man Ellaria Lee ◽  
Ralph A. Lugo ◽  
William J. Rusho ◽  
Mark MacKay ◽  
John Sweeley
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Chemical Stability ◽  
High Performance ◽  
Room Temperature ◽  
Final Concentration ◽  
Sterile Water ◽  
Initial Concentration ◽  
Two Temperatures ◽  
The Mean

The objective of this study was to determine the chemical stability of extemporaneously prepared lorazepam suspension (1 mg/mL) stored at two temperatures (4°C and 22°C) for 3 months. Lorazepam tablets marketed by two manufacturers (Mylan Pharmaceuticals and Watson Laboratories) were used to extemporaneously formulate two independently prepared suspensions. Each suspension was prepared using sterile water, Ora-Plus® and Ora-Sweet® to achieve a final concentration of 1 mg/mL. The two brands of tablets required different volumes of vehicles to prepare a pharmaceutically optimal suspension. The suspensions were stored in amber glass bottles at 4°C and 22°C for 91 days. Samples were analyzed by high performance liquid chromatography at baseline and on days 2, 3, 7, 14, 21, 28, 42, 63, and 91. The suspensions were considered stable if the mean lorazepam concentration remained greater than 90% of the initial concentration. The chemical stabilities of these two extemporaneously prepared lorazepam suspensions were comparable throughout the study. Both lorazepam suspensions were stable for 63 days when stored at 4°C or 22°C, and both were stable for 91 days when refrigerated at 4°C. When stored at room temperature, the suspension prepared from the Watson tablet retained 88.9 ± 1.4% of the initial concentration on day 91 and was therefore considered unstable, while the suspension prepared from the Mylan tablet was stable for the entire 91-day study.

scholarly journals Stability and Compatibility of Antibiotics in Peritoneal Dialysis Solutions Applied to Automated Peritoneal Dialysis in the Pediatric Population

2016 ◽  
Vol 36 (6) ◽  
pp. 676-679 ◽  
Author(s):  
Guillaume Deslandes ◽  
Matthieu Grégoire ◽  
Régis Bouquié ◽  
Aude Le Marec ◽  
Sophie Allard ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Pediatric Population ◽  
Drug Concentrations ◽  
Baxter Healthcare ◽  
Yellow Coloration ◽  
The Stability ◽  
Dialysis Solutions

ObjectivesAssess the stability of several antibiotics in peritoneal dialysis (PD) solutions under common conditions of use in pediatrics, particularly in automated PD.MethodsAmoxicillin, cefazolin, cefepime, ceftazidime, imipenem, cotrimoxazole, tobramycin, vancomycin, and the association of ceftazidime + vancomycin and ceftazidime + tobramycin, were tested in 3 different PD solutions: bicarbonate/lactate solution with 2 glucose concentrations (Physioneal 1.36 and 3.86%; Baxter Healthcare Corporation, Deerfield, IL, USA) and an icodextrin-containing solution (Extraneal; Baxter Healthcare Corporation, Deerfield, IL, USA). Concentrations were those recommended in guidelines for the treatment of peritonitis in pediatrics. Physioneal bags were incubated at 37°C for 24 hours, whereas Extraneal bags were stored 12 hours at room temperature (22 ± 2°C) and then 12 hours at 37°C. Drug concentrations were determined using high performance liquid chromatography (HPLC). Each measure was taken in triplicate. Stability of antibiotics was defined as less than 10% degradation of the drug over time.ResultsCefazolin, cotrimoxazole, tobramycin, and vancomycin were stable under studied conditions. Ceftazidime was stable 24 hours in icodextrin, 12 hours in Physioneal 1.36% and 6 hours in Physioneal 3.86%. The association of tobramycin or vancomycin did not influence the stability of ceftazidime. Cefepime and amoxicillin were stable 6 h, 4 h, and 8 h in Physioneal 1.36%, 3.86% and Extraneal, respectively. The stability of imipenem was very low: 2 h in Physioneal and 6 h in Extraneal. Moreover, an increasingly yellow coloration was observed with the use of imipenem, whereas no color change or precipitation occurred in other bags.ConclusionCefazolin, tobramycin, cotrimoxazole, and vancomycin are stable in PD solutions up to 24 hours and can be administered in the PD bag for the treatment of peritonitis, even in automated PD under studied conditions. However, amoxicillin, cefepime, ceftazidime, and imipenem must be used with caution due to their lack of stability.

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