更新于：2024-11-08
Novast Laboratories Ltd.
更新于：2024-11-08
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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
丙戊酸钠缓释片（Ⅰ）人体生物等效性研究
100 项与 南通联亚药业股份有限公司 相关的临床结果
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2024-01-04Journal 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
作者: Kowtharapu, Leela Prasad ; Chintala, Vaishnavi ; Ediga, Sasikiran Goud ; Katari, Naresh Kumar ; Ch, Rajyalakshmi ; 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.
2009-01-01
Developing Solid Oral Dosage Forms
作者: Geoff Zhang ; Lirong Liu ; Yisheng Chen ; William Porter ; Yihong Qiu
Fundamental of diffusion and dissolution
作者: 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 项与 南通联亚药业股份有限公司 相关的药物交易
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100 项与 南通联亚药业股份有限公司 相关的转化医学
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