scholarly journals Stability studies of common biochemical analytes in serum separator tubes with or without gel barrier subjected to various storage conditions

2012 ◽  
pp. 202-214 ◽  
Author(s):  
Serap Cuhadar ◽  
Ayşenur Atay ◽  
Mehmet Koseoglu ◽  
Ahmet Dirican ◽  
Aysel Hur
Keyword(s):  
Storage Conditions ◽  
Stability Studies ◽  
Gel Barrier

Formation of an amorphous silica gel barrier under CO2 storage conditions

2018 ◽  
Vol 78 ◽  
pp. 27-36 ◽  
Author(s):  
C.A. Castañeda-Herrera ◽  
J.R. Black ◽  
E.M. Llanos ◽  
G.W. Stevens ◽  
R.R. Haese
Keyword(s):  
Silica Gel ◽  
Amorphous Silica ◽  
Co2 Storage ◽  
Storage Conditions ◽  
Gel Barrier

Stability of extemporaneously prepared rosuvastatin oral suspension

2017 ◽  
Vol 74 (19) ◽  
pp. 1579-1583 ◽  
Author(s):  
Abdel Naser Zaid ◽  
Rania Shtayah ◽  
Ayman Qadumi ◽  
Mashour Ghanem ◽  
Rawan Qedan ◽  
...  
Keyword(s):  
Relative Humidity ◽  
High Performance ◽  
Room Temperature ◽  
Microbial Contamination ◽  
Active Pharmaceutical Ingredient ◽  
Storage Conditions ◽  
Dissolution Profile ◽  
Stability Studies ◽  
Organoleptic Properties ◽  
The Stability

Abstract Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

scholarly journals FORMULATION, CHARACTERIZATION AND STABILITY STUDY OF FAST DISSOLVING THIN FILM CONTAINING ASTAXANTHIN NANOEMULSION USING HYDROXYPROPYLMETHYL CELLULOSE POLYMER

2021 ◽  
pp. 17-22
Author(s):  
LUSI NURDIANTI ◽  
IYAN SOPYAN ◽  
TAOFIK RUSDIANA
Keyword(s):  
Thin Film ◽  
Mechanical Characteristics ◽  
Storage Conditions ◽  
Stability Study ◽  
Matrix System ◽  
Stability Studies ◽  
Casting Method ◽  
Hydroxypropylmethyl Cellulose ◽  
The Stability ◽  
Physical And Mechanical Characteristics

Objective: The present study was conducted to formulate and characterize the thin film containing astaxanthin nanoemulsion (TF-ASN) using Hydroxypropylmethyl Cellulose (HPMC) polymer as a film matrix system. The stability studies in different storage conditions were also performed. Methods: Astaxanthin nanoemulsion (As-NE) was prepared by using self-nanoemulsifying method, followed by incorporation into the HPMC matrix system by solvent casting method to forming TF-ASN. Evaluation of TF-ASN was performed by physical and mechanical characterizations. Stability study was carried out in both of accelerated (temperature of 40±2 °C/75±5% RH) and non-accelerated (at ambient temperature) conditions. Assay of astaxanthin in individual TF-ASN was determined compared to pure astaxanthin. Results: TF-ASN had good physical and mechanical characteristics that suitable for intraoral administration. Conclusion: For the study of stability under different storage conditions, it was proven that nanoemulsion form was packed in a HPMC matrix could enhance the stability of the astaxanthin.

Stability studies of ubiquinol in plasma

2003 ◽  
Vol 40 (1) ◽  
pp. 100-101 ◽  
Author(s):  
M.P.C. Hectors ◽  
L.J.H. van Tits ◽  
Y.B. de Rijke ◽  
P.N.M. Demacker
Keyword(s):  
Storage Conditions ◽  
Final Concentration ◽  
Butylated Hydroxytoluene ◽  
Stability Studies ◽  
Defence Mechanism ◽  
First Line ◽  
Antioxidative Defence

Background: Ubiquinol is a sensitive redox marker in the first line of the antioxidative defence mechanism and is increasingly being measured in oxidation studies. Because of its apparent instability during storage and processing, we compared various storage conditions. Method: Blood was collected from three volunteers into tubes containing EDTA; it was then separated at 4°C and cryopreserved with saccharose (final concentration 6 g/L). Aliquots were stored with or without glutathione or butylated hydroxytoluene at -20°C and -80°C. Results and conclusion: Ubiquinol in samples stored at -20°C was not stable; however, it was stable when stored at -80°C, even without addition of antioxidant. By contrast, α-tocopherol was stable under all conditions studied.

scholarly journals Determination of Mirabegron in rat plasma by UPLC–MS/MS after oral and intravenous administration

2019 ◽  
Vol 65 (2) ◽  
pp. 141-148 ◽  
Author(s):  
Lingdi Chen ◽  
Yu Zhang
Keyword(s):  
Intravenous Administration ◽  
Adrenergic Receptor ◽  
Storage Conditions ◽  
Rat Plasma ◽  
Precipitation Method ◽  
Stability Studies ◽  
Positive Ion ◽  
Concentration Curves ◽  
Adrenergic Receptor Agonist

SUMMARY Mirabegron is a kind of β3 adrenergic receptor agonist which is an effective drug for the treatment of overactive bladder. In this research, a UPLC–MS/MS method is developed and validated for the study of mirabegron pharmacokinetic in rats. A protein precipitation method is applied for sample preparation with acetonitrile. m/z 397.3→379.6, m/z 326.4→121.0 for mirabegron, tolterodine (IS), respectively in the positive ion mode was performed for quantitation. The method is reliable and reproducible in our study (intra-day precision≤11.06%, inter-day precision≤11.43%) with concentration curves linear from 5 to 2500 ng/mL(R2>0.999). Stability studies demonstrated that mirabegron was stable under a variety of storage conditions. This method was successfully applied for determining mirabegron in rats after oral and intravenous administration.

Regulatory 101: Bulk Holding Time Requirements

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Karen Zimm ◽  
Renee Phillips
Keyword(s):  
Development Process ◽  
Storage Conditions ◽  
Pharmaceutical Products ◽  
Product Development Process ◽  
Stability Studies ◽  
Process Stability ◽  
Drug Products ◽  
Time Requirements ◽  
Product Specifications ◽  
Intended Use

The FDA website provides guidance on various CGMP topics. The focus of this installment of Regulatory 101 is on the topic of bulk holding requirements. The question posed via the Q&A on CGMP’s is stated as “How long may a firm store in-process/intermediate powder blends and triturations, sustained-release pellets/beads, and tablet cores, absent separate stability studies, before using them in finished drug products?” Additional considerations are provided to further analyze this frequently asked question. Pharmaceutical products are manufactured to ensure safety, effectiveness, and quality for their intended use. As part of the product development process, stability studies are conducted to determine the appropriate shelf life for the product under specified storage conditions. These studies ensure all product specifications are met up to the assigned expiration date.

Statistical Analysis for Long-term Stability Studies with Multiple Storage Conditions

2011 ◽  
Vol 45 (3) ◽  
pp. 301-314 ◽  
Author(s):  
Edwin R. van den Heuvel ◽  
Osama Almalik ◽  
Michiel B. Nijhuis ◽  
Edward I. Warner
Keyword(s):  
Statistical Analysis ◽  
Storage Conditions ◽  
Stability Studies ◽  
Term Stability ◽  
Long Term Stability

scholarly journals Physicochemical Stability Studies of Tablet Containing A Mixture of Sonchus Arvensis L Leaves Extract and Lumbricus rubellus Powder

2017 ◽  
Vol 9 (5) ◽  
Author(s):  
Syukri Y. ◽  
Anshory H. ◽  
Romadhonsyah F.
Keyword(s):  
Physical Stability ◽  
Chemical Properties ◽  
Storage Conditions ◽  
Stability Test ◽  
Lumbricus Rubellus ◽  
Wet Granulation ◽  
Stability Studies ◽  
Disintegration Time ◽  
Weight Variation ◽  
Sonchus Arvensis

The aim of this study was to determine the physical and chemical stabilities of tablets containing Sonchus arvensis L leaves extract and Lumbricus rubellus. The tablets were produced by wet granulation process. The stability test was observed during a 3-month accelerated stability under 40 ± 2ºC and 75 ± 5% RH storage conditions. The tablets were evaluated every month for the physical properties include organoleptic, weight variation, friability, hardness, and disintegration time, while the chemical properties of the tablets include Rf value, and spotting profile was examined using TLC-Densitometry. The result of the physical stability test up to the third month showed that the tablets of Sonchus arvensis leaves extract and Lumbricus rubellus met the requirements of Indonesian Pharmacopeia 5th and United State Pharmacopeia 32. The qualitative chemical property stability test on the tablets also demonstrated that luteolin as a marker compound remained stable in the tablets after three months of storage in an accelerated condition. Conclusion, the formulation of a tablet containing Sonchus arvensis leaves extract and Lumbricus rubellus stable after this stability studies.

scholarly journals Stability of Cefuroxime Axetil Oral Suspension at Different Temperature Storage Conditions

2008 ◽  
Vol 8 (1) ◽  
pp. 93-96 ◽  
Author(s):  
Alija Uzunović ◽  
Edina Vranić
Keyword(s):  
Drug Release ◽  
Storage Conditions ◽  
Cefuroxime Axetil ◽  
Oral Suspension ◽  
Stability Testing ◽  
Stability Studies ◽  
Concentration Changes ◽  
The Stability ◽  
Temperature Storage

Stability testing of an active substance or finished product provides information of the variation of drug substance or final product with time influenced by a variety of environmental factors such as temperature, humidity and light. Knowledge gained from stability studies enables understanding of the effects of the environment on the drugs.The aim of our study was to determine the stability of cefuroxime axetil oral suspension at different temperature storage conditions (stored at room /20°C/ and refrigerated /5°C/ conditions). Determination of cefuroxime (as cefuroxime axetil) was performed by dissolution testing.Fractions of the released cefuroxime axetil were compared usingJ2 value. After interpolating data for dissolution profiles at room and refrigerated conditions the following f2values were obtained: 62,56; 56,32 and 36,18 on 3rd, 6th and 10th day, respectively. These values indicate similarities in drug release from analyzed cefuroxime axetil oral suspension on 3rd, 6th day, and differences on 10th day.Based on our results, we may assume that cefuroxime axetil oral suspension preserves its stability for 10 days after reconstitution under room and refrigerated conditions. It is obvious, according to the f2 value obtained on the 10th day, that there is a difference between the released ceforoxime axetil from oral suspension at room (87,68%) and refrigerated (92,35%) conditions. Concentration changes can be caused by the mechanisms associated with drug release and hydrolytical decomposition of the sample and higher temperatures during longer period of storage.

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