Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s

Bhaskar, Rajveer; Ola, Monika; Agnihotri, Vinit V.; Chavan, Arjun; Girase, Harpalsing

doi:10.22270/jddt.v10i2-s.4040

Cited by 11 publications

(13 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…According to section 211.166(a) (3) of these guidelines, a SIM should be highly precise and capable of quantifying the amount of active ingredient present, whether these types of degradation products occur, as well as other components present in dosage form, without interference under stress. pH, temperature, and oxygen are three stress conditions that are needed for forced degradation studies [13,19].…”

Section: Fda Guidelines (Food and Drug Administration)mentioning

confidence: 99%

“…This guideline gives the knowledge about the If no degradation criterion or contaminants are available, the specificity should be calculated by comparing the data to the results obtained degradation product or contaminants using a different method under the same accelerated conditions [3,19].…”

Section: Usp Pharmacopoeia: Validation Of Compendia Proceduresmentioning

confidence: 99%

“…This guideline notes that the proposed method must be precise in order to classify and detect the amount of analyte present in the sample. Samples may be subjected to stress conditions for comparative studies, and degradation products can be used for further studies if reference standards are not available [19].…”

Section: Japanese Pharmacopoeiamentioning

confidence: 99%

“…It was created with the aim of promoting public health. It also encourages states, districts, and municipalities to promote the Brazilian unified health system's principles in order to enhance overall quality of life [19].…”

Section: Anvisa (National Health Surveillance Agency)mentioning

confidence: 99%

See 3 more Smart Citations

Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

Ambhore¹,

Adhao²,

Cheke³

et al. 2021

GSC Biol. and Pharm. Sci.

View full text Add to dashboard Cite

Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summarizes the current regulatory requirements guidelines for the laboratory performance of forced degradation and its application for the development of stability indicating method. There are number of strategies have been implemented for the quantitative assessment of antiviral drugs. This study will provide detailed literature on stability- indicating HPLC/ RP-HPLC approaches for the development and validation of various antiviral drugs.

show abstract

Section: Fda Guidelines (Food and Drug Administration)mentioning

confidence: 99%

Section: Usp Pharmacopoeia: Validation Of Compendia Proceduresmentioning

confidence: 99%

Section: Japanese Pharmacopoeiamentioning

confidence: 99%

Section: Anvisa (National Health Surveillance Agency)mentioning

confidence: 99%

See 2 more Smart Citations

Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

Ambhore¹,

Adhao²,

Cheke³

et al. 2021

GSC Biol. and Pharm. Sci.

View full text Add to dashboard Cite

show abstract

“…Importance of stability testing [11][12][13][14][15][16] 1. Determining conditions of shelf life and processing for the development of new goods 2.…”

Section: Introductionmentioning

confidence: 99%

A Review on Stability Testing Guidelines of Pharmaceutical Products

Zothanpuii¹,

Rekapalli²,

Selvakumar³

2020

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Stability studies must be carried out according to the guidelines provided by the International Conference of Harmonization, World Health Organization, and other agencies in a scheduled manner. The pharmaceutical product’s stability can be defined as the ability, within its physical, chemical, microbiological, toxicology, protective, and informational requirements of a particular formulation in a specific container-closure system. It also guarantees that the performance, safety, and efficacy are maintained throughout the shelf life of any pharmaceutical product which is considered as pre-requisite for acceptance and approval. Different stability test methods have originated with the need for constant monitoring of drugs and products for their quality and purity. In this review, we have included the types of stability of drugs substances, the relevance of different methods used to test the stability of the pharmaceutical product, guidelines issued to test the stability of pharmaceuticals, stability testing protocols which describes the main components of a well-controlled and regulated stability test and other aspects of stability.

show abstract

Impurity profiling and stability‐indicating method development and validation for the estimation of assay and degradation impurities of midostaurin in softgel capsules using HPLC and LC–MS

Lakka

Kuppan

Ravinathan³

2021

Biomedical Chromatography

View full text Add to dashboard Cite

Midostaurin (MDS) is used for the treatment of acute myeloid leukemia, myelodysplastic syndrome, and advanced systemic mastocytosis. MDS softgel capsule samples were subjected to stress testing per International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for impurity profiling study. MDS underwent extensive degradation under stress testing (acid, alkaline, oxidative, photolytic, thermolytic, and hydrolysis conditions) and formed four degradation products (DPs). MDS and its DPs were separated well from one another with good resolution using reserved-phase HPLC using an Inertsil ODS-3V column (250 Â 4.6 mm, 5 μm) and a mobile phase of ammonium formate (40 mM) and acetonitrile. The stability-indicating characteristic of the newly developed method was proven for the estimation of MDS assay, and its organic impurities were free from interference. The validated method exhibited excellent linearity, accuracy, precision, specificity, detection limit, and quantitation limit within 25 min run time. Stress testing, robustness, and solution stability were performed to ensure the continuous performance of the developed method. The peak fractions of DPs formed under stress testing were isolated and characterized using LC-MS, 1 H and 13 C NMR, IR, and UV-Vis. The structure of the major DPs was predicted as DP1 based on the spectral data. The proposed method is effectively used for MDS in bulk drug and finished formulations in the pharmaceutical industry.

show abstract

Current Trend in Performance of Forced Degradation Studies for Drug Substance and Drug Product’s

Cited by 11 publications

References 2 publications

Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs

A Review on Stability Testing Guidelines of Pharmaceutical Products

Impurity profiling and stability‐indicating method development and validation for the estimation of assay and degradation impurities of midostaurin in softgel capsules using HPLC and LC–MS

Contact Info

Product

Resources

About