scholarly journals Quality Control in Pharmaceuticals: Residual Solvents Testing and Analysis

10.5772/23041 ◽  
2011 ◽  
Author(s):  
Changqin Hu ◽  
Ying Liu
Keyword(s):  
Quality Control ◽  
Residual Solvents

scholarly journals Isoflavone Stability Quality Control Assessment of Q-CAN® Plus, a Novel Fermented Soy Beverage (P12-034-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Wajahat Mehal ◽  
Eric Secor ◽  
Theresa Weiss ◽  
Maxine Fields ◽  
Michael Leapman ◽  
...  
Keyword(s):  
Heavy Metals ◽  
Quality Control ◽  
Microbial Contamination ◽  
Soy Isoflavones ◽  
Third Party ◽  
Biological Research ◽  
Residual Solvents ◽  
Funding Sources ◽  
Relevant Dose ◽  
Mold And Yeast

Abstract Objectives The purpose of this investigation is to validate the soy isoflavone content, 24 months stability and quality control of “Q-CAN® Plus,” a novel fermented soy beverage imported from China. Methods Q-CAN® Plus was independently tested through third-party laboratories for: Soy isoflavones, microbial contamination, herbicides, pesticides, fungicides, heavy metals and residual solvents. To evaluate the potency or stability, total soy isoflavones were measured over 24 months through accelerated (40 degrees Celsius 75% relative humidity) and shelf (ambient temperature) and microbial contamination evaluated. Results Upon initial analysis Q-CAN® Plus contained 290.12 mg of total soy isoflavones. Microbial contamination, mold and yeast were absent or WNLs. Product was free of herbicides, pesticides, fungicides, heavy metals and residual solvents. The mean total isoflavones was 303.23 mg +/− 11.5 mg (SD). The 24-month stability testing in both the accelerated chamber (12 mo = 294 mg, 24 mo = 318 mg) and shelf (12 mo = 304 mg, 24 mo = 310 mg) determined that total soy isoflavones did not significantly change in potency, and microbiology analysis at each time point revealed no contamination. Conclusions In this first independent evaluation of Q-CAN® Plus it was determined that the manufacturer's Certificate of Analysis was validated, soy isoflavones remained stable over 24 months, and microbial contamination was absent. Q-CAN® Plus is a functional beverage that provides a high quality, clinically relevant dose of soy isoflavones. Future investigations will determine the clinical benefit of this natural fermented soy beverage. Funding Sources Beso Biological Research, Inc.

scholarly journals Analytical procedure for quality control of 18F-Choline radiopharmaceutical

2021 ◽  
Vol 63 (5) ◽  
pp. 10-16
Author(s):  
Thanh Quang Vu ◽  
◽  
Ngoc Khoan Ha ◽  
Thanh Rin Bui ◽  
Trung Dung Nguyen ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Radiochemical Purity ◽  
Analytical Procedure ◽  
Hplc Method ◽  
Central Hospital ◽  
Residual Solvents ◽  
Quality Specifications ◽  
Pet Radiopharmaceutical ◽  
Required Quality

18Fluoromethylcholine (18F-Choline, 18F-FCH) has been produced using a home-made automatic synthesiser at 30 MeV Cyclotron Centre, 108 Military Central Hospital. In order to be licensed using for patients, the 18F-FCH radiopharmaceutical needs to meet the required quality specifications listed in the pharmacopeia. The objective of this study was to build up the analytical procedure and to perform for the 18F-FCH quality control followed the EuPh2017 pharmacopeia for the PET radiopharmaceutical. The result obtained confirmed that the total time to complete the test of one sample of the 18F-FCH was less than 35 min. Identifications of 18F-FCH, radiochemical purity, and 18F content were determined with accuracy >96% by High-performance liquid chromatography (HPLC) method and content of residual solvents consists of Ethanol, Acetonitrile, Dibromomethane, Dimethylethanolamine were determined with the accuracy >97% by Gas chromatography (GC) method.

A new matrix-matched calibration strategy for static headspace gas chromatography to enable high throughputs in pharmaceutical quality control laboratories

2019 ◽  
Vol 11 (33) ◽  
pp. 4242-4248 ◽  
Author(s):  
Dirk Jung ◽  
Jörg-Detlef Kreher ◽  
Hans-Ullrich Kratz ◽  
Ulrike Michalik
Keyword(s):  
Gas Chromatography ◽  
Quality Control ◽  
Matrix Effects ◽  
Headspace Gas Chromatography ◽  
Static Headspace ◽  
Organic Substances ◽  
Residual Solvents ◽  
Static Headspace Gas Chromatography ◽  
Volatile Organic ◽  
Headspace Gas

The analysis of residual solvents or generally, volatile organic substances using static headspace gas chromatography, is often accompanied by matrix effects.

Validation of an analytical method for quality control of residual solvents (n-hexane and acetone) in D-002: New active ingredient from beeswax

2008 ◽  
Vol 47 (3) ◽  
pp. 646-650 ◽  
Author(s):  
Ernesto Méndez Antolín ◽  
Yaisme Balcinde Quiñónez ◽  
Víctor González Canavaciolo ◽  
Esperanza Rodríguez Cruz
Keyword(s):  
Quality Control ◽  
Active Ingredient ◽  
Analytical Method ◽  
Residual Solvents

Health communication ethics and CDC quality-control guidelines for information

2003 ◽  
Vol 118 (3) ◽  
pp. 193-196 ◽  
Author(s):  
Jeffrey W McKenna ◽  
Terry F Pechacek ◽  
Donna F Stroup
Keyword(s):  
Quality Control ◽  
Health Communication ◽  
Communication Ethics

Quality control and the medical record

1971 ◽  
Vol 127 (1) ◽  
pp. 101-105 ◽  
Author(s):  
L. L. Weed
Keyword(s):  
Quality Control ◽  
Medical Record
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