How to solve unspecified impurity issue of Fondaparinux Sodium Injection?

11 July 2023 0 7K Report

I am working with development of Fondaparinux Sodium Prefilled Syringe Injection. But I am struggling with unspecified impurity generation in the finished product. How can I solve this issue? The inactive excipients are similar to RLD product (ARIXTRA) and is Sodium Chloride. and pH is adjusted with NaOH or HCL if necessary.

More Nanziba Shahed's questions See All

How can I calculate the amount of desorbed CO2 (mmol/g) in CO2-TPD analysis? Or consumption amount of H2 in H2-TPR?

TPD/TPR

04 January 2024 4,711 3 View

Could anyone tell me whether the circled results below are resistant, susceptible or intermidiate?

I did lawn on an E. coli strain onto a plate of Mueller-Hinton agar. For other plates I got clear zones of inhibition, but for few particular antibiotics (CRO, OFX and CIP) against this strain...

20 December 2023 7,248 4 View

How to solve Related Compound C(Known Impurity) issue in Pregabalin extended release tablets formulation?

I am working with formulation development of Pregabalin Extended Release tablets. But I am facing trouble with a known Impurity. During stability this impurity is increasing rapidly. i have done...

31 October 2022 5,108 1 View

Which software to use for analyzing porosity network in bone from micro-CT?

I have ct scan data of parietal bone. I am trying to create the pore network using Avizo. Unfortunately, the segmentation and the subsequent analysis from the avizo following this tutorial...

05 August 2022 7,310 3 View

What's the best way to store Ciliates (protozoa) for RNA isolation ?

I have some samples (few cells of ciliates) are preserved in RNAlater. So is there any problem if I start my work by adding lysis buffer for RNA extraction in my preserved samples stored in...

16 May 2018 8,660 3 View

What is the most convenient tool to predict the secondary structure for RNA and also for visualizing tools for the structure?

RNA secondary structure prediction and editing tools.

29 April 2014 2,115 4 View

How to determine the boundary or the region of ITS1 (internal transcribed space 1) , specially for ciliates

Thanks for your input.

23 March 2014 4,793 3 View

Intra and interspecific sequence divergence?

How to calculate intra and interspecific sequence variability form 30 sequences using MEGA 5?

11 January 2014 7,773 7 View

What is the most appropriate test for significance of two survival curves that cross over more than once?

The survival curve for the exposed and unexposed group cross over more than once over the time period of 6 months. I was wondering if log rank test is still appropriate to test for significance?

19 November 2012 1,685 16 View

How to increase protein lysate concentration?

I am trying to prepare samples for IP. The pellet size is good and I am using 1% Tx-100 and using a syringe to further lyse the cells and maintain protein-protein interactions. I keep having a...

01 August 2024 7,199 1 View

Sodium azide in immunohistochemistry?

Hello everyone, A collaborator sent us his protocol in order to be able to use his immunohistochemistry kits. But one step contains PBS + 0.3% H2O2 + 0.1% sodium azide. Knowing the dangerousness...

23 July 2024 6,314 3 View

Why my gel electrophoresis has smearing?

Greetings. I’m currently running a nested pcr for giardia. My mastermix comprised of 3mM Mgcl2, 5unit of taq polymerase, 0.2uM of forward and reverse primers each respectively and 0.2mM of dNtp...

22 July 2024 9,761 5 View

How do I prepare a working stock solution of 14C sodium bicarbonate to get a final activity of 3uCi?

I need to make a stock solution for radioisotopic incubations of freshwater sediments to study dark primary productivity but I have some confusion as to how I calculate the concentration of 14C...

15 July 2024 5,898 0 View

Why am I seeing only one initial maximum in torque-time curves for the fusion of PVC in a Brabender?

We're studying the stability and fusion behavior of multiple PVC compounds in a Brabender. After a few trials, we set the temperature at 195 °C and the rotor speed at 70 rpm. Samples differ in...

12 July 2024 2,768 1 View

Validated HPLC method for the estimation of the Amphotericin B ?

During the release test of Amphotericin B using 1% Tween 80, i observed three peaks even in the standard. The first peak consistently yielded results around 500%, while the other peaks showed...

08 July 2024 1,330 0 View

Does Fentanyl presence in injecting drug user communities require special harm reduction measures?

With Fentanyl already being detected in some countries in Europe, I believe many of us are not educated enough on special needs of injection drug users that use Fentanyl, due to its high strength...

08 July 2024 7,694 3 View

Can we detect DOC fractions through LC-OCD for a sample containing Sodium Azide?

I did some column tests in my lab where I needed to detect the DOC fractions using LC-OCD. For the abiotic columns I used sodium azide to restrict the biofilm formation. I did LC-OCD to detect the...

07 July 2024 468 0 View

What can be done when electronic minimization does not converge during geometry optimization in CASTEP?

Hello All, I've been facing difficulty in executing geometry optimization of a sodium polyanionic phosphate (Na4Fe3P4O15) crystal in CASTEP (please find the input and output files attached). When...

07 July 2024 8,626 2 View

Can an Ischemic Buffer Alone Effectively Mimic Hypoxia in an In Vitro Cardiac Cell Hypoxia-Reoxygenation Model?

I am working on an in-vitro model of hypoxia-reoxygenation (H/R) in cardiac cells (H9c2). Due to the unavailability of a hypoxic incubator, I am exploring alternative methods to create hypoxic...

30 June 2024 1,234 2 View