China
Africa
Explore chapters and articles related to this topic
Quality Control of Ayurvedic Medicines
Published in D. Suresh Kumar, Ayurveda in the New Millennium, 2020
V. Remya, Maggie Jo Alex, Alex Thomas
Preparation of ariṣṭa and āsava involves fermentation. The purity of raw materials and water, hygienic design of equipment used for production, physical separation of high care areas where critical operations are carried out and in which barriers are raised to prevent the entry of micro-organisms from raw materials, people, air or utensils and effective cleaning and disinfection of equipment and facilities are required to ensure product quality (Baxter and Hughes 2001).
Characterization of Phyto-Constituents
Published in Rohit Dutt, Anil K. Sharma, Raj K. Keservani, Vandana Garg, Promising Drug Molecules of Natural Origin, 2020
Himangini, Faizana Fayaz, Anjali
Purity is closely associated with secure usage of medicines including the factors like contaminants (e.g., foreign particulate present as other herbs), ash values, and heavy metals, etc. But, within the current generation of analytical strategies, improved purity test includes radioactivity, bacterial, and fungal infection, pesticide residues, and aflatoxins (Swatantra et al., 2010). Analysis such as spectroscopic techniques (UV, IR, MS, and NMR), gas chromatography (GC), thin-layer chromatography (TLC), high-performance thin-layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), volumetric, and gravimetric analysis are important for quantitative as well as qualitative characterization of small amounts of foreign matter used for quality control and standardization (Booksh et al., 1994).
Practice exam 5: Answers
Published in Euan Kevelighan, Jeremy Gasson, Makiya Ashraf, Get Through MRCOG Part 2: Short Answer Questions, 2020
Euan Kevelighan, Jeremy Gasson, Makiya Ashraf
The risks include accidental overdose or sudden withdrawal, which can be associated with drugs of inconsistent purity (1). Women drug users often have poor nutrition and malabsorption, leading to iron, folate and vitamin deficiencies (1). If the woman uses needles, cellulitis, phlebitis and superficial thrombosis may develop (1). [Deep venous thrombosis can occur with femoral vein use.] Abscesses and, rarely, necrotizing fasciitis can occur with extravasation of the drug (1). [Systemic infection can develop following these local infections and this may present as septicaemia.] Hepatitis B and C and human immunodeficiency virus (HIV) infection are associated with intravenous drug use (1).
Gene therapy for alpha-1 antitrypsin deficiency: an update
Published in Expert Opinion on Biological Therapy, 2023
Debora Pires Ferreira, Alisha M Gruntman, Terence R Flotte
At present, serum AAT augmentation therapy, which uses protein purified from pooled healthy human plasma, is still the only specific pharmacological intervention available for the treatment of AATD [1]. The AAT protein replacement strategy sufficiently raises the serum and alveolar epithelial lining fluid (ELF) to the U.S. Food and Drug Administration (FDA) and the European regulatory agencies considered protective levels (over 11 mM and 1.2 mM, respectively), for about 4.5 days [8]. However, this form of treatment only reduces symptom severity and is costly, limited in supply, variable in purity and activity, and can also be a burden for patients due to the need for lifetime weekly intravenous (IV) administration to maintain therapeutic concentrations [9]. Moreover, this therapy addresses only AATD-lung manifestations and does not treat the potential liver disease [10].
Development and Clinical Translation Considerations for the Next Wave of Gene Modified Hematopoietic Stem and Progenitor Cells Therapies
Published in Expert Opinion on Biological Therapy, 2022
Matthew Li, Brent Morse, Sadik Kassim
The criticality of gene modification reagents requires the production of these reagents utilizing sufficient controls in order to achieve the desired Quality Target Product Profile (QTPP) and CQAs of the drug product. First and foremost, key safety parameters (sterility, mycoplasma, endotoxin, replication competent virus) should be strictly controlled to minimize risk to the patient. Likewise, other purity parameters associated with the manufacture (e.g. host cell protein and DNA for protein and viral manufacture) should be controlled to minimize the need for testing in the drug product. Content and purity controls should be considered to minimize variability in drug product manufacturing, and in some cases (e.g. single guide RNA manufacture) may play a role in minimizing safety risks from off-target editing. Oftentimes, developers will require custom materials and will need to internally resource accordingly to improve oversight as they apply to specific pipeline programs. Also for consideration is the characterization of in-process usage (e.g. RNP formation) due to impact on product potency. For most, if not all, of these reagents the regulatory expectation is that the manufacturing should be conducted in accordance with cGMP.
The Effects of Vitamin E, Silymarin and Carnitine on the Metabolic Abnormalities Associated with Nonalcoholic Liver Disease
Published in Journal of Dietary Supplements, 2022
John E. Poulos, Peter T. Kalogerinis, Valentin Milanov, Constantine T. Kalogerinis, Emanuel J. Poulos
Authentication and verification of the content and stability of VSC involved Fourier Transform Infrared Spectroscopy, Fourier transform near-infrared spectroscopy, High-performance thin-layer chromatography, and compendial monograph testing for positive identification of all materials. Ultra-Performance Convergence chromatography was utilized for the analysis of vitamin E. All operations and processes in the manufacturing of VSC were conducted in accordance with current Good Manufacturing Practices (cGMPs) as required by the United State Food and Drug Administration under 21 CFR, Part 111 (Dietary Supplements) and Part 117 (Food Safety). Physical testing including USP disintegration, dissolution, physical appearance, and identification. Also, the purity of all finished products was confirmed via testing for heavy metals (inductively coupled plasma mass spectrometry), pesticides (liquid chromatography-mass spectrometry), and residual solvents, as well as microbiological testing. The testing of finished VSC was conducted in comparison to established finished product specifications contained within a controlled database that stipulates the label claims and acceptable ranges for each ingredient. Certificates of Analysis (COA) were issued for each batch of finished product via a state-of-the-art laboratory information system (LIMS) listing the applicable laboratory testing that was conducted and the specifications used.