GOOD Manufacturing Practice Guide for Active Pharmaceutical Ingredients

2009 ◽  
pp. Vol 4-48-Vol 4-67
Keyword(s):  
Good Manufacturing Practice ◽  
Active Pharmaceutical Ingredients ◽  
Practice Guide ◽  
Pharmaceutical Ingredients

scholarly journals Determination of the glucose residues on pharmaceutical equipment surfaces by both methods: polarimetry and HPLC

2018 ◽  
pp. 83-89
Author(s):  
A. А. Fedosenko ◽  
Yu. V. Scrypynets ◽  
I. I. Leonenko ◽  
A. V. Yegorova ◽  
S. N. Kashutskуy ◽  
...  
Keyword(s):  
Good Manufacturing Practice ◽  
Oral Solution ◽  
Process Equipment ◽  
Cross Contamination ◽  
Active Pharmaceutical Ingredients ◽  
Rapid Methods ◽  
Membrane Filters ◽  
Pharmaceutical Ingredients

Cleaning of equipment in the production of medicines is an important requirement of good manufacturing practice (GMP). As a rule, the same process equipment is used for the production of a number of different drugs that may result in cross-contamination. In order to prevent the contamination there is need in efficient cleaning of equipment used with the validation methods for each part of equipment. There is need as well to prove and establish acceptable residual limits of active pharmaceutical ingredients (API) on the surface of the equipment after purification (purity acceptance criteria) based on the therapeutic dose of API, toxicity, volume of series, the surface area of the used equipment. The aim of this work is the development of the simple and selective polarimetry and HPLC methods for determining residual amounts of glucose in washings from surfaces of pharmaceutical equipment after production of the drug. The object of the research is glucose, which is a part of the drug Regidron, powder for oral solution of 18.9 g per sachet. The swab Alpha® Sampling Swab TX715; membrane filters 0.20 µm; Minisart RC 15 «Sartorius» (Germany) were used. The polarimetric and HPLC methods for determination of glucose residues in washings from surfaces of pharmaceutical equipment after production the Regidron were developed. The recovery rates of glucose from swabs and pharmaceutical equipment surfaces are more than 90%. The proposed simple and rapid methods are characterized by satisfactory metrological characteristics and can be recommended to determine the residues of glucose in controlling the quality of cleaning pharmaceutical equipment.

Reversed-Phase High Performance Liquid Chromatographic Analysis of Three First Line Anti-Tuberculosis Drugs

2019 ◽  
Vol 69 (12) ◽  
pp. 3590-3592
Author(s):  
Nela Bibire ◽  
Romeo Iulian Olariu ◽  
Luminita Agoroaei ◽  
Madalina Vieriu ◽  
Alina Diana Panainte ◽  
...  
Keyword(s):  
High Performance ◽  
Biological Fluids ◽  
Gradient Elution ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Assay Method ◽  
Active Pharmaceutical Ingredients ◽  
First Line ◽  
Pharmaceutical Ingredients ◽  
Liquid Chromatographic

Active pharmaceutical ingredients such as isoniazid, pyrazinamide and rifampicin are among the most important first-line anti-tuberculosis drugs. A simple, rapid and sensitive reversed phase-high performance liquid chromatographic assay method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin has been developed. Separation of the interest compounds was achieved in a 10 min chromatographic run in gradient elution mode on a Zorbax SB-C18 stainless steel column (150 � 4 mm, 5 mm) using a guard column containing the same stationary phase. The gradient elution was carried out with a mobile phase of 10% CH3CN aqueous solution for channel A and 50% CH3CN in pH = 6.8 phosphate buffer (20 mM), to which 1.5 mL triethylamine were added for channel B. Quantification of the analyzed substances was carried out spectrophotometrically at 269 nm. Detection limits of 0.48 mg/L for isoniazid, 0.52 mg/L for pyrazinamide and 0.48 mg/L for rifampicin were established for the developed assay method. The present work showed that the proposed analysis method was advantageous for simple and rapid analysis of the active pharmaceutical ingredients in pharmaceuticals and biological fluids.

scholarly journals Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins

AMB Express ◽  
2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bach-Ngan Nguyen ◽  
Florian Tieves ◽  
Thomas Rohr ◽  
Hilke Wobst ◽  
Felix S. Schöpf ◽  
...  
Keyword(s):  
Fermentation Broth ◽  
High Titer ◽  
New Technology ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Expression Platform ◽  
Small Proteins ◽  
Production Platform ◽  
Β Amyloid ◽  
Cost Efficient

AbstractThe production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.

scholarly journals Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 610
Author(s):  
Mariann Inga Van Meter ◽  
Salah M. Khan ◽  
Brynne V. Taulbee-Cotton ◽  
Nathan H. Dimmitt ◽  
Nathan D. Hubbard ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Mass Spectrometry Imaging ◽  
Laser Desorption ◽  
Ionization Mass Spectrometry ◽  
Ionization Mass ◽  
Active Pharmaceutical Ingredients ◽  
Laser Desorption Ionization ◽  
Over The Counter ◽  
Pharmaceutical Ingredients ◽  
Desorption Ionization

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

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