Active Pharmaceutical Ingredient
Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants
... It is advisable for Active Pharmaceutical Ingredient manufacturing facilities to hold an official Cleaning Validation Policy. Specific department responsibilities should be outlined in this and it ...
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Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants
... the active pharmaceutical ingredient committee (APIC) of ...in active pharmaceutical ingredient manufacturing plants has received a large amount of attention from regulators, ...
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CiteSeerX — A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
... of active pharmaceutical ingredient, that is, L-Cysteine, N, N -1,2- ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality ...
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Palladium Impurity Removal from Active Pharmaceutical Ingredient Process Streams277-286
... **[email protected] In this article, we will look at palladium impurity removal from active pharmaceutical ingredient (API) process streams using metal scavengers and the drivers for the ...
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Kinetics of Active Pharmaceutical Ingredient Solubility in Water with Different Hydrogen Isotopic Content
... of pharmaceutical substances with the purpose of dissolution quantitative evaluation, as well as with the aim of tackling the issue of new active pharmaceutical ingredients' low solubility while ...
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Simultaneous Determination of N Acetyl Cysteine and Taurine by HPTLC Method in Active Pharmaceutical Ingredient and Pharmaceutical Dosage Form
... A. R. Magesh, Magharla Dasaratha Dhanaraju * GIET School of Pharmacy, Rajahmundry, India Abstract Specific, precise and sensitive TLC-Densitometric method was developed and validated for the simultaneous estimation of ...
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Analytical method for piperazine in an active pharmaceutical ingredient using chemical derivatization and HPLC UV
... A method to form a UV-active derivative of piperazine was developed. The method was based on the reaction of piperazine with NBD-Cl (4-chloro-7-nitrobenzofuran), forming a stable derivative, which was ...
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Use of Nanohybrid Material for Formulation, Development and Evaluation of Pharmaceutical Dosage Form Containing the Low Solubility Active Pharmaceutical Ingredient
... Keywords- BCS Class II, Nanohybrids, Solubilization, Enhancement of solubility, Optimized drug dissolution and drug release. Article Info: Received 14 Sep 2019; Review Completed 09 Nov 2019; Accepted 19 Nov 2019; ...
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HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient
... HPLC Method Development and Validation for the Quantification of Related Impurities in Testosterone Cypionate Active Pharmaceutical Ingredient.. Amber Bharti 1,2, *, Ravindra Motiram K[r] ...
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Kit formulation of active pharmaceutical ingredient d,l-HMPAO as a brain perfusion diagnostic system
... synthesis of the active pharmaceutical ingredient (d,l- HMPAO) for the preparation of 99mTc-d,l-HMPAO radiopharmaceutical. In addition, different kit formulations were suggested, with minor ...
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Inventory Modeling for Active Pharmaceutical Ingredient Supply Chains by Audrey Bazerghi B.Eng., Polytechnique Montreal (2015)
... CPFs can help guide future improvements specific to an Active Pharmaceutical Ingredient (API) supply chain. Since not all nodes behave according to the intuitive framework of “everything else being ...
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Vendor qualification: Utilization of solid state characterization “Toolbox” to assess material variability for active pharmaceutical ingredient
... One of the credos for a successful product development, early clinical trial supplies, achieving full-scale manufacturability and speed to the market is the vendor qualification. The focus of this paper is to employ a ...
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Carotenoid and Chlorophyll Profiles in Five Species of Malaysian Seaweed as Potential Halal Active Pharmaceutical Ingredient (API)
... Abstract— Seaweed, also known as macroalgae, consist of various species that have been gaining the interest of researchers due to the presence of functional bioactive compounds that can be extracted from their biomass. ...
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Development and Validation of Genotoxic Impurity in Esomeprazole Magnesium Trihydrate Active Pharmaceutical Ingredient by LC-MS/MS
... Objectives: A rapid, sensitive and selective analytical method has been developed and validated by liquid chromatography tandem Mass spectrometry (LC-MS/MS) for the quantification of traces of Cumene Hydroperoxide in ...
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Development of methods for the chromatographic identification of active pharmaceutical ingredient from group of angiotensin-converting enzyme inhibitors in pharmaceuticals
... Abstract Introduction: Thin-layer chromatography (TLC) is a chromatography used to separate non-volatile mixtures. TLC can be used for monitoring the progress of a reaction, identification compounds present in a given ...
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Crystal structure of pirfenidone (5 methyl 1 phenyl 1H pyridin 2 one): an active pharmaceutical ingredient (API)
... an active pharmaceutical ingredient (API) approved in Europe and Japan for the treatment of Idiopathic pulmonary fibrosis (IPF), is reported here for the first ...
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The Use of Shift Reagents in Ion Mobility-Mass Spectrometry: Studies on the Complexation of an Active Pharmaceutical Ingredient with Polyethylene Glycol Excipients
... an active pharmaceutical ingredient (API), lamivudine, have been carried out using electrospray ionization-ion mobility spectrometry-quadrupole-time-of-flight mass spectrometry (ESI-IMS- ...
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The use of shift reagents in ion mobility-mass spectrometry: studies on the complexation of an active pharmaceutical ingredient with polyethylene glycol excipients
... an active pharmaceutical ingredient in formulations of Combivir™, used to treat Human Immunodeficiency Virus (HIV) infection, PEG 400 and Lamivudine/PEG mixtures were analysed using ESI-IM-MS, ...
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STABILITY TESTING OF ACTIVE PHARMACEUTICAL INGREDIENT [API]
... It is considered good practice to test the stability of drug substances according to the International Conference on Harmonization (ICH) and Committee for Propriet[r] ...
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Equivalence in active pharmaceutical ingredient of generic antihypertensive
... • More than a quarter of some commonly prescribed anti-hypertensive medicines available in Nigeria appear to be of substandard quality (samples had more or less SAPI, than stated in t[r] ...
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