IMPACT OF EXCIPIENT VARIABILITY ON DRUG PRODUCT PROCESSING AND PERFORMANCE

2015 ◽  
Vol 21 (40) ◽  
pp. 5890-5899 ◽  
Author(s):  
Josephine Peng Soh ◽  
Celine Liew ◽  
Paul Sia Heng
Keyword(s):  
Drug Product ◽  
Excipient Variability ◽  
And Performance

SIMULTANEOUS ANALYSIS OF A THREE COMPONENT MIXTURE BY VIERODT’S SIMULTANEOUS EQUATION METHOD

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 40-42
Author(s):  
A Palekar ◽  
◽  
S. Gaude ◽  
S. P. N. Pai
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Drug Product ◽  
Simultaneous Equation ◽  
Simultaneous Equations ◽  
Simultaneous Estimation ◽  
Component Mixture ◽  
Percent Recovery ◽  
And Performance ◽  
Tablet Dosage

A simple, rapid, sensitive and economical UV spectrophotometric method was developed and validated for the simultaneous estimation of aspirin, caffeine, and orphenadrine citrate by Vierodt’s method in combined tablet dosage form and using mixture of 0.1 N HCl: ethanol (1:1) as solvent. The method employs designing and solving of simultaneous equations using 3 wavelengths, namely 226 nm, 272 nm, and 210 nm. Beer’s law was obeyed in the concentration range of 3-18 μg/mL for aspirin and 0.5-12 μg/mL for both caffeine and orphenadrine citrate with r2 value of 0.993, 0.991, and 0.991 respectively. Accuracy was determined by recovery studies and showed percent recovery ranging from 99.78-100% for aspirin, 96.10-100.92% for caffeine and 100.53-102.5% for orphenadrine citrate. The developed method can be used in QC laboratory for routine analysis to ensure the identity, purity, and performance of the drug product.

RP-HPLC Method Development and Validation of Tadalafil in Tablet Dosage form

2021 ◽  
pp. 380-388
Author(s):  
Chavan Pooja Ajit ◽  
Shelar Reshma Dattatraya ◽  
Shelake Pallavi Ramchandra ◽  
Avinash Mahadeo Bhagwat ◽  
Ajit Bhiva Ekal
Keyword(s):  
Analytical Method ◽  
Method Development ◽  
Drug Product ◽  
Hplc Method ◽  
Clinical Samples ◽  
Development Effort ◽  
Chromatography Method ◽  
Method Development And Validation ◽  
And Performance ◽  
Development And Validation

Tadalafil is a phosphodiesterase 5 inhibitor accustomed to treat dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. Tadalafil is an orally administered drug and it's marketed worldwide under the name Cialis. Analytical method development and validation play important roles within the discovery development and manufacture of pharmaceuticals. These methods is to make sure the identity, purity, potency, and performance of drug product. The bulk of the analytical development effort goes into validating a stability indicating HPLC–method. Analytical method development could be a process of proving that the developed chromatography method is suitable for its intended use within the development and manufacturing of the pharmaceutical drug substance and drug product. All analytical methods that are intended to be used for analyzing any clinical samples will have to be validated. The target of the strategy validation is to demonstrate that the strategy is suitable for its intended purpose because it is stated in ICH guidelines.

scholarly journals A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Bashir Daoud Agha Dit Daoudy ◽  
Mohammad Ammar Al-Khayat ◽  
Francois Karabet ◽  
Mohammad Amer Al-Mardini
Keyword(s):  
Chromatographic Method ◽  
Drug Product ◽  
Static Headspace ◽  
Pharmaceutical Excipients ◽  
Accuracy And Precision ◽  
Headspace Gas ◽  
And Performance ◽  
Gas Chromatographic Method ◽  
Headspace Gc ◽  
Detection And Quantification

Formaldehyde is a highly reactive impurity that can be found in many pharmaceutical excipients. Trace levels of this impurity may affect drug product stability, safety, efficacy, and performance. A static headspace gas chromatographic method was developed and validated to determine formaldehyde in pharmaceutical excipients after an effective derivatization procedure using acidified ethanol. Diethoxymethane, the derivative of formaldehyde, was then directly analyzed by GC-FID. Despite the simplicity of the developed method, however, it is characterized by its specificity, accuracy, and precision. The limits of detection and quantification of formaldehyde in the samples were of 2.44 and 8.12 µg/g, respectively. This method is characterized by using simple and economic GC-FID technique instead of MS detection, and it is successfully used to analyze formaldehyde in commonly used pharmaceutical excipients.

Transmission Scanning Electron Microscopy and Energy Analysis with the Siemens ELMISKOP 101

1972 ◽  
Vol 30 ◽  
pp. 450-451
Author(s):  
H. M. Thieringer
Keyword(s):  
Objective Lens ◽  
Transmission Microscopy ◽  
Image Recording ◽  
Mode Of Operation ◽  
Scanning Transmission ◽  
Electron Microscopes ◽  
And Performance ◽  
Convergent Beam ◽  
Ray Path ◽  
Beam Diffraction

It has repeatedly been show that with conventional electron microscopes very fine electron probes can be produced, therefore allowing various micro-techniques such as micro recording, X-ray microanalysis and convergent beam diffraction. In this paper the function and performance of an SIEMENS ELMISKOP 101 used as a scanning transmission microscope (STEM) is described. This mode of operation has some advantages over the conventional transmission microscopy (CTEM) especially for the observation of thick specimen, in spite of somewhat longer image recording times.Fig.1 shows schematically the ray path and the additional electronics of an ELMISKOP 101 working as a STEM. With a point-cathode, and using condensor I and the objective lens as a demagnifying system, an electron probe with a half-width ob about 25 Å and a typical current of 5.10-11 amp at 100 kV can be obtained in the back focal plane of the objective lens.

Angular Resolved Electron Spectroscopy with Parallel Recording

1990 ◽  
Vol 48 (2) ◽  
pp. 370-371
Author(s):  
Huang Min ◽  
P.S. Flora ◽  
C.J. Harland ◽  
J.A. Venables
Keyword(s):  
Electron Spectroscopy ◽  
Low Voltage ◽  
Solid Angle ◽  
Detection System ◽  
Voltage Electron ◽  
Cylindrical Mirror ◽  
Inner Radius ◽  
Channel Plate ◽  
And Performance ◽  
Type Detector

A cylindrical mirror analyser (CMA) has been built with a parallel recording detection system. It is being used for angular resolved electron spectroscopy (ARES) within a SEM. The CMA has been optimised for imaging applications; the inner cylinder contains a magnetically focused and scanned, 30kV, SEM electron-optical column. The CMA has a large inner radius (50.8mm) and a large collection solid angle (Ω > 1sterad). An energy resolution (ΔE/E) of 1-2% has been achieved. The design and performance of the combination SEM/CMA instrument has been described previously and the CMA and detector system has been used for low voltage electron spectroscopy. Here we discuss the use of the CMA for ARES and present some preliminary results.The CMA has been designed for an axis-to-ring focus and uses an annular type detector. This detector consists of a channel-plate/YAG/mirror assembly which is optically coupled to either a photomultiplier for spectroscopy or a TV camera for parallel detection.

Novel epoxy/anhydride alternatives for biological electron microscopy: Physical and performance characteristis of embed 812 and LX 112 in combination with NSA/NMA/DMAE

1989 ◽  
Vol 47 ◽  
pp. 1000-1001
Author(s):  
Joe A. Mascorro ◽  
Gerald S. Kirby
Keyword(s):  
Electron Microscopy ◽  
Flow Rate ◽  
Succinic Anhydride ◽  
Volume Flow Rate ◽  
Mass Density ◽  
Uranyl Acetate ◽  
Volume Flow ◽  
Base Resin ◽  
And Performance ◽  
Acid Anhydrides

Embedding media based upon an epoxy resin of choice and the acid anhydrides dodecenyl succinic anhydride (DDSA), nadic methyl anhydride (NMA), and catalyzed by the tertiary amine 2,4,6-Tri(dimethylaminomethyl) phenol (DMP-30) are widely used in biological electron microscopy. These media possess a viscosity character that can impair tissue infiltration, particularly if original Epon 812 is utilized as the base resin. Other resins that are considerably less viscous than Epon 812 now are available as replacements. Likewise, nonenyl succinic anhydride (NSA) and dimethylaminoethanol (DMAE) are more fluid than their counterparts DDSA and DMP- 30 commonly used in earlier formulations. This work utilizes novel epoxy and anhydride combinations in order to produce embedding media with desirable flow rate and viscosity parameters that, in turn, would allow the medium to optimally infiltrate tissues. Specifically, embeding media based on EmBed 812 or LX 112 with NSA (in place of DDSA) and DMAE (replacing DMP-30), with NMA remaining constant, are formulated and offered as alternatives for routine biological work.Individual epoxy resins (Table I) or complete embedding media (Tables II-III) were tested for flow rate and viscosity. The novel media were further examined for their ability to infilftrate tissues, polymerize, sectioning and staining character, as well as strength and stability to the electron beam and column vacuum. For physical comparisons, a volume (9 ml) of either resin or media was aspirated into a capillary viscocimeter oriented vertically. The material was then allowed to flow out freely under the influence of gravity and the flow time necessary for the volume to exit was recored (Col B,C; Tables). In addition, the volume flow rate (ml flowing/second; Col D, Tables) was measured. Viscosity (n) could then be determined by using the Hagen-Poiseville relation for laminar flow, n = c.p/Q, where c = a geometric constant from an instrument calibration with water, p = mass density, and Q = volume flow rate. Mass weight and density of the materials were determined as well (Col F,G; Tables). Infiltration schedules utilized were short (1/2 hr 1:1, 3 hrs full resin), intermediate (1/2 hr 1:1, 6 hrs full resin) , or long (1/2 hr 1:1, 6 hrs full resin) in total time. Polymerization schedules ranging from 15 hrs (overnight) through 24, 36, or 48 hrs were tested. Sections demonstrating gold interference colors were collected on unsupported 200- 300 mesh grids and stained sequentially with uranyl acetate and lead citrate.

Sign in / Sign up

Export Citation Format

Share Document