Last update 08 Nov 2024
Novast Laboratories Ltd.
Last update 08 Nov 2024
Overview
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A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-Arm, Parallel-Study to Evaluate the Bioequivalence using Clinical Endpoint of generic conjugated estrogens vaginal cream, 0.625 mg/g (Novast Laboratories, Ltd., China) to Premarin® (conjugated estrogens) vaginal cream, 0.625mg/g (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.), in healthy postmenopausal women with symptoms of vulvar and vaginal atrophy. - nil
美沙拉秦肠溶片人体生物等效性研究
[Translation] Study on the bioequivalence of mesalazine enteric-coated tablets in healthy volunteers
丙戊酸钠缓释片（Ⅰ）人体生物等效性研究
[Translation] Bioequivalence study of sodium valproate sustained-release tablets (Ⅰ) in healthy volunteers
100 Clinical Results associated with Novast Laboratories Ltd.
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04 Jan 2024Journal of AOAC International
Quantification of Drospirenone- and Ethinyl Estradiol-Related Impurities in a Combined Pharmaceutical Dosage Form by a Chromatography Method With a QbD Robustness Study
Article
Author: Kowtharapu, Leela Prasad ; Chintala, Vaishnavi ; Ediga, Sasikiran Goud ; Ch, Rajyalakshmi ; Katari, Naresh Kumar ; Nandimalla, Vishnu ; Chinta, Srinivasa Reddy
Abstract:
Background:
The estimation of drugs containing drospirenone (DRSP) and ethinyl estradiol (EE), and their related impurities, in low-dose oral contraceptive drug products is an extremely challenging target. The proposed research sought to develop and validate a stability-indicating method for quantifying drug substances and their related impurities in tablet formulation.
Objective:
To develop and validate a simple, specific, accurate, precise, and stability-indicating reverse-phase (RP)-HPLC method for quantification of DRSP, EE, and their impurities in accordance with International Conference on Harmonisation (ICH) guidelines.
Method:
The separation was achieved using an Agilent Zorbax SB C18 column (4.6 mm × 250 mm, 5 µm) with a detection wavelength of 215 nm and mobile phases A (100% acetonitrile) and B (acetonitrile–water, 1 + 3, v/v) at a flow rate of 1.3 mL/min and a column temperature of 40°C.
Results:
The recovery study of each impurity was conducted in the range of 24 to 72 µg/mL for DRSP-related impurities and 0.2 to 0.6 µg/mL for EE-related impurities with respect to the specification limit. A linearity study was conducted over a range of 1.5 to 90 µg/mL for DRSP and DRSP-related impurities, and 0.125 to 0.75 µg/mL for EE-related impurities. A Quality by Design (QbD) study demonstrated the method’s robustness.
Conclusions:
As per current guidelines, a stability-indicating method has been developed for the determination of impurities in DRSP/EE film-coated tablets. A QbD-based robustness test was performed and the method was found to be robust.
Highlights:
An accurate, precise, stability-indicating, gradient RP-HPLC method has been developed and validated to determine DRSP, EE, and nine related impurities in tablet formulation. A QbD technique was used to establish a robustness study.
01 Jan 2009
Developing Solid Oral Dosage Forms
Author: Geoff Zhang ; Lirong Liu ; Yisheng Chen ; William Porter ; Yihong Qiu
Fundamental of diffusion and dissolution
Author: Chen, Y. ; Wang, J. ; Flanagan, D. R.
This article studies about review of the fundamental theory and the basic equations of diffusion to facilitate the further application of diffusion theory in pharmaceutical sciences.
100 Deals associated with Novast Laboratories Ltd.
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100 Translational Medicine associated with Novast Laboratories Ltd.
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