Comparison of product-related impurities.

Monitoring of product variants (*) by RP-HPLC.

Katrin Bomans (335277)
Antje Lang (490435)
Veronika Roedl (490436)
Lisa Adolf (490437)
Kyrillos Kyriosoglou (490438)
Katharina Diepold (335276)
Gabriele Eberl (490439)
Michael Mølhøj (335284)
Ulrike Strauss (490440)
Christian Schmalz (490441)
Rudolf Vogel (490442)
Dietmar Reusch (335285)
Harald Wegele (490443)
Michael Wiedmann (335278)
Patrick Bulau (335286)

November 2013

Batches with different HCP content at drug substance level (A) and the product elution pool after...

RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION

N. A. Epshtein
V. L. Sevastianova
A. I. Koroleva

January 2019

The recommendations of admissible corrections of the chromatographic conditions provided in chapter ...

Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS

Schneider, Alex
Wessjohann, Ludger A.
Severi, Juliana A.
Wagner, Vilegas

April 2012

Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...

Scatter plots for product-related impurities.

Arati Deshmukh (16806764)
Rishank Goyal (16806767)
Kalyana Sundaram (16806770)
Kaustubh Dange (16806773)
Tejshri Lakhote (16806776)
Sanjay Niranjan (2139496)
Jennifer Bharucha (16806779)
Ashok Mishra (16806782)
Bhavesh Vats (10737927)
Sanjay Tiwari (1669654)

August 2023

(A) Aggregates, (B) HMW A+B, (C) Main peak, and (D) Total HMW measured by SE-HPLC. (E) Aggregates me...

Comparison of several curve resolution methods for drug impurity profiling using high-performance liquid chromatography with diode array detection

van Zomeren, P. V.
Darwinkel, H.
Coenegracht, P. M. J.
de Jong, G. J.

July 2003

The performance of five curve resolution methods was compared systematically for the identification ...

Representative CEx-HPLC profile of POP Sample I4 showing Pre-peak impurity 1 (RRT 0.60), Pre-peak impurity 2 (RRT 0.73) and Pre-peak impurity 3 (RRT 0.84).

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Representative CEx-HPLC profile of POP Sample I4 showing Pre-peak impurity 1 (RRT 0.60), Pre-peak im...

CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW)

N. A. Epshtein

February 2019

Introduction. In case of methods of impurities determination quite often there are problems connecte...

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta using SEC-HPLC.

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta using SEC-HPLC.</p

Comparison of chromatographic profiles.

Arati Deshmukh (16806764)
Rishank Goyal (16806767)
Kalyana Sundaram (16806770)
Kaustubh Dange (16806773)
Tejshri Lakhote (16806776)
Sanjay Niranjan (2139496)
Jennifer Bharucha (16806779)
Ashok Mishra (16806782)
Bhavesh Vats (10737927)
Sanjay Tiwari (1669654)

August 2023

(A) Reduced peptide mapping by UV detection, (B) Reduced peptide mapping by MS analysis (with identi...

Analysis and impurity identification in pharmaceuticals

Prajapati Prajesh
Agrawal Yadvendra K.

August 2014

Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned ...

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta by CEx-HPLC.

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta by CEx-HPLC.</p

Comparison of three development approaches for Stationary Phase Optimised Selectivity Liquid Chromatography based screening methods Part II: A group of structural analogues (PDE-5 inhibitors in food supplements).

E. Deconinck
L. Ghijs
A. Kamugisha
P. Courselle

January 2016

Three approaches for the development of a screening method to detect adulterated dietary su...

Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review)

N. A. Epshtein

August 2020

Introduction. When developing and validating methods of impurity determination, it is important to t...

Comparison of different liquid chromatographic methods for analysis of free gossypol.

Aparecido Almeida Conceição (5264213)
Clemente Batista Soares Neto (5124875)
José Antônio de Aquino Ribeiro (5124869)
Felix Gonçalves de Siqueira (5124878)
Robert Neil Gerard Miller (5124872)
Simone Mendonça (2826221)

May 2018

Comparison of different liquid chromatographic methods for analysis of free gossypol.</p

Analytical Size Exclusion chromatograms and SDS-Page gel electrophoresis photos of selected hSTIM1 constructs.

Jonathan How (290136)
Ai Zhang (290138)
Margaret Phillips (290140)
Aline Reynaud (290141)
Si Yan Lu (290142)
Lucy Xin Pan (290143)
Hai Ting Ho (290144)
Yin Hoe Yau (113342)
Albert Guskov (290146)
Konstantin Pervushin (248559)
Susana Geifman Shochat (115541)
Said Eshaghi (290149)

February 2013

The scoring of the chromatograms is differentiated into High, Medium and Low quality. The chromat...

Monitoring of product variants (*) by RP-HPLC.

Katrin Bomans (335277)
Antje Lang (490435)
Veronika Roedl (490436)
Lisa Adolf (490437)
Kyrillos Kyriosoglou (490438)
Katharina Diepold (335276)
Gabriele Eberl (490439)
Michael Mølhøj (335284)
Ulrike Strauss (490440)
Christian Schmalz (490441)
Rudolf Vogel (490442)
Dietmar Reusch (335285)
Harald Wegele (490443)
Michael Wiedmann (335278)
Patrick Bulau (335286)

November 2013

Batches with different HCP content at drug substance level (A) and the product elution pool after...

RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION

N. A. Epshtein
V. L. Sevastianova
A. I. Koroleva

January 2019

The recommendations of admissible corrections of the chromatographic conditions provided in chapter ...

Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS

Schneider, Alex
Wessjohann, Ludger A.
Severi, Juliana A.
Wagner, Vilegas

April 2012

Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...

Scatter plots for product-related impurities.

Arati Deshmukh (16806764)
Rishank Goyal (16806767)
Kalyana Sundaram (16806770)
Kaustubh Dange (16806773)
Tejshri Lakhote (16806776)
Sanjay Niranjan (2139496)
Jennifer Bharucha (16806779)
Ashok Mishra (16806782)
Bhavesh Vats (10737927)
Sanjay Tiwari (1669654)

August 2023

(A) Aggregates, (B) HMW A+B, (C) Main peak, and (D) Total HMW measured by SE-HPLC. (E) Aggregates me...

Comparison of several curve resolution methods for drug impurity profiling using high-performance liquid chromatography with diode array detection

van Zomeren, P. V.
Darwinkel, H.
Coenegracht, P. M. J.
de Jong, G. J.

July 2003

The performance of five curve resolution methods was compared systematically for the identification ...

Representative CEx-HPLC profile of POP Sample I4 showing Pre-peak impurity 1 (RRT 0.60), Pre-peak impurity 2 (RRT 0.73) and Pre-peak impurity 3 (RRT 0.84).

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Representative CEx-HPLC profile of POP Sample I4 showing Pre-peak impurity 1 (RRT 0.60), Pre-peak im...

CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW)

N. A. Epshtein

February 2019

Introduction. In case of methods of impurities determination quite often there are problems connecte...

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta using SEC-HPLC.

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta using SEC-HPLC.</p

Comparison of chromatographic profiles.

Arati Deshmukh (16806764)
Rishank Goyal (16806767)
Kalyana Sundaram (16806770)
Kaustubh Dange (16806773)
Tejshri Lakhote (16806776)
Sanjay Niranjan (2139496)
Jennifer Bharucha (16806779)
Ashok Mishra (16806782)
Bhavesh Vats (10737927)
Sanjay Tiwari (1669654)

August 2023

(A) Reduced peptide mapping by UV detection, (B) Reduced peptide mapping by MS analysis (with identi...

Analysis and impurity identification in pharmaceuticals

Prajapati Prajesh
Agrawal Yadvendra K.

August 2014

Impurity is not a much-liked word by pharmaceutical and industry people, because they are concerned ...

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta by CEx-HPLC.

Rakesh Shekhawat (6453941)
Chintan Kumar Shah (6453944)
Akash Patel (128728)
Sankaranarayanan Srinivasan (116202)
Poonam Kapoor (6453947)
Suvaskumar Patel (6453950)
Sharwan Kumar (6453953)
Sandeep Sonar (6453956)
Namrata More (6453959)
Manasvi Joshi (6453962)
Jatin Patel (3415787)
Milan Vachhani (6453965)
Bhargav Prasad Kodaganti (6453968)
Upasana Choavatiya (6453971)
Arabhi Pushpaja (6453974)
Shubhangi Argade (6453977)
Nidhi Nuwal (6453980)
Manish Kumar (50435)
Sridevi Khambhampaty (6453983)

March 2019

Quantitative purity analysis of INTP5, US Neulasta and EU Neulasta by CEx-HPLC.</p

Comparison of three development approaches for Stationary Phase Optimised Selectivity Liquid Chromatography based screening methods Part II: A group of structural analogues (PDE-5 inhibitors in food supplements).

E. Deconinck
L. Ghijs
A. Kamugisha
P. Courselle

January 2016

Three approaches for the development of a screening method to detect adulterated dietary su...

Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review)

N. A. Epshtein

August 2020

Introduction. When developing and validating methods of impurity determination, it is important to t...

Comparison of different liquid chromatographic methods for analysis of free gossypol.

Aparecido Almeida Conceição (5264213)
Clemente Batista Soares Neto (5124875)
José Antônio de Aquino Ribeiro (5124869)
Felix Gonçalves de Siqueira (5124878)
Robert Neil Gerard Miller (5124872)
Simone Mendonça (2826221)

May 2018

Comparison of different liquid chromatographic methods for analysis of free gossypol.</p

Analytical Size Exclusion chromatograms and SDS-Page gel electrophoresis photos of selected hSTIM1 constructs.

Jonathan How (290136)
Ai Zhang (290138)
Margaret Phillips (290140)
Aline Reynaud (290141)
Si Yan Lu (290142)
Lucy Xin Pan (290143)
Hai Ting Ho (290144)
Yin Hoe Yau (113342)
Albert Guskov (290146)
Konstantin Pervushin (248559)
Susana Geifman Shochat (115541)
Said Eshaghi (290149)

February 2013

The scoring of the chromatograms is differentiated into High, Medium and Low quality. The chromat...

Monitoring of product variants (*) by RP-HPLC.

Katrin Bomans (335277)
Antje Lang (490435)
Veronika Roedl (490436)
Lisa Adolf (490437)
Kyrillos Kyriosoglou (490438)
Katharina Diepold (335276)
Gabriele Eberl (490439)
Michael Mølhøj (335284)
Ulrike Strauss (490440)
Christian Schmalz (490441)
Rudolf Vogel (490442)
Dietmar Reusch (335285)
Harald Wegele (490443)
Michael Wiedmann (335278)
Patrick Bulau (335286)

November 2013

Batches with different HCP content at drug substance level (A) and the product elution pool after...

RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION

N. A. Epshtein
V. L. Sevastianova
A. I. Koroleva

January 2019

The recommendations of admissible corrections of the chromatographic conditions provided in chapter ...

Comparison of impurity profiles of lipiblock® vs. orlistat using HPLC and LC-MS/MS

Schneider, Alex
Wessjohann, Ludger A.
Severi, Juliana A.
Wagner, Vilegas

April 2012

Comparative HPLC-UV and LC-MS/MS studies of impurity profiles of a reference sample (Xenical®, F. Ho...

Comparison of product-related impurities.

Abstract

Extracted data

Comparison of product-related impurities.

Abstract

Extracted data

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