Showing 1-30 of 205 results for "usp"
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Elemental Impurities - Certified Reference Materials for ICH Q3D, USP 232, USP 2232, and Ph.Eur. 5.20
Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
Ultrapure Water Elemental Impurities USP
This paper demonstrates the suitability of fresh ultrapure water produced using Milli-Q® water purification systems for analyses of elemental impurities according to General Chapters USP <231>; <232>; and <233>.
USP <921>: Methods for Moisture Determination and Karl Fischer Titration
USP <921>: Methods for Moisture Determination and Karl Fischer Titration
USP HPLC Analysis of L-Methionine on Ascentis® Express OH5
Separation of L-Methionine, Pharmaceutical Secondary Standard; Certified Reference Material
USP HPLC Analysis of Ampicillin Sodium on Ascentis® Express C18
USP HPLC Analysis of Ampicillin Sodium on Ascentis<sup>®</sup> Express C18
An Alternative to the USP and EP Methods for the Analysis of Riboflavin (Vitamin B₂) and Impurities
An MS-compatible alternative to the USP and EP methods, with improved specificity and reduced analysis time.
Sildenafil Citrate USP Method Using HPTLC Plates for the Limit of Imidazole Test
In the present study we demonstrate compliance of silica gel 60 F254 HPTLC plates with USP requirements, and how HPTLC plates are suitable for the Sildenafil citrate-Limit of Imidazole test.
Chloroquine Phosphate HPLC Assay and Impurity Profiling Methods Following the USP Monograph
Under applied conditions, system suitability criteria are met, and the Chloroquine Phosphate HPLC Assay and Impurity Profiling Methods demonstrate good resolution/selectivity, reproducibility, and sensitivity.
Sildenafil Citrate Method (HPLC) following USP Monograph on Ascentis Express C18 with UV detection
Sildenafil Citrate Method (HPLC) following USP Monograph on Ascentis Express C18 with UV detection
USP Dissolution Testing Method (HPLC) for Folic Acid Tablets Using a Monolith Column and UV detection
Folic acid or folate is classified as a B vitamin (B9). Folic acid is synthetically produced, and used in fortified foods and supplements. Folate is converted by humans to dihydrofolate (dihydrofolic acid), tetrahydrofolate (tetrahydrofolic acid), and other derivatives, which have various biological...
Famciclovir Tablets USP Monograph Method Using a Purospher™ STAR RP-8 endcapped HPLC Column and UV Detection
Following the new USP monograph for Famciclovir Tablets, Purospher™ STAR RP-8 endcapped HPLC columns can be used to monitor organic impurities in Famciclovir tablet formulations. Famciclovir is an antiviral drug indicated for the treatment of herpes zoster, herpes simplex virus...
Improving the Current USP Method for the Analysis of Lansoprazole Drug Substance Using HPLC Columns Based on Fused-Core® Particle Technology
Compendial methods from the USP (United States Pharmacopeia) are widely used in pharmaceutical drug product and raw materials testing. However, not all methods in the USP use modern technologies. In chromatographic methods, it is not uncommon that older brands of...
Pharmaceutical Secondary Standards Certificate of Analysis Tracking
From time to time, the Compendial Lots that these Secondary Standards are made traceable to change
Inorganic Elemental Impurity Mix Standards
Browse through our selection of reference materials of inorganic elemental impurity mixes as per ICHQ3D guidelines for your ICP or AAS based tests of drug products in pharmaceutical analysis.
HPLC Analysis of Fexofenadine and Related Compound B on CYCLOBOND® I 2000 Phases
The use of alternative chiral stationary phases to CYCLOBOND I 2000 SP suggested by USP, was studied for the analysis of fexofenadine and related compound B.
Pharmaceutical Secondary Standards
Convenient and cost-effective alternative to primary reference standards, with traceability to USP, BP, EP standards; manufactured to ISO/IEC 17025 and ISO Guide 34.
Identification, Assay and Organic Impurity Profiling Methods for Aripiprazole following the United States Pharmacopeia Monograph
Aripiprazole is an atypical antipsychotic and a partial dopamine agonist. It is primarily used in the treatment of schizophrenia, bipolar disorder, major depressive disorder, tic disorders, and irritability associated with autism. Aripiprazole was first approved by the U.S. Food and...
Biomolecule Formulation
Specifically developed for high-risk biopharmaceutical applications, our high-quality process chemicals and excipients help you to minimize the regulatory and quality-associated risks of biomolecule formulation.
A Fast and Reliable Method for Purity Analysis of Filgrastim
Optimized USP method for filgrastim, a recombinant form of human granulocyte colony stimulating factor (GCSF). Used in different biologics, it is crucial to know the purity of filgrastim.
Biomolecule Formulation
Specifically developed for high-risk biopharmaceutical applications, our high-quality process chemicals and excipients help you to minimize the regulatory and quality-associated risks of biomolecule formulation.
Upstream Process Chemicals
Our portfolio of upstream process chemicals provides biopharmaceutical manufacturers with high-quality raw materials for every stage from research to commercial application, backed by supply chain transparency, reliable sourcing, and best-in-class regulatory support.
GC Column Selection Guide
In 1983, the first special purpose fused silica capillary GC column was introduced. Since then, an impressive list of special purpose fused silica capillary GC columns has followed.
Inorganic elemental impurity mixes according to ICH Q3D guidelines
In 2009, the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients. This approach provides clear regulatory guidance on specification limits for...
Buffers & pH Adjusters
Our broad portfolio of buffer materials manufactured according to GMP guidelines includes excipients specifically for drug formulation and manufacturing, including high-risk applications. Whether your product is a small or large molecule drug, we offer high-quality buffers and pH adjusters with...
Titration Reagents
Our broad range of volumetric solutions make titration results trustful. Sophisticated packaging like the Titripac® and 3S cap and innovative solutions to improve the titration process. Seamless data transfer via RFID tag is available with our SmartChemicals and 3S reagents.
Dexamethasone HPLC Assay and Impurity Profiling Methods Following United States Pharmacopeia Monograph Guidelines Using a Titan C18 Column and UV Detection
A simple, precise and sensitive Reverse-Phase High Pressure Liquid Chromatography gradient method was adapted for traceability, homogeneity and total chromatographic analysis of Dexamethasone. The given experimental conditions follow the USP43-NF38 monograph method for Dexamethasone Assay and Organic Impurity Profiling. Dexamethasone...
Chromolith® HPLC and UHPLC columns
Chromolith® HPLC and UHPLC columns are made from monolithic silica with a bimodal pore structure using sol-gel technology.
Titration & Karl Fischer Titration
Titration is an analytical method to determine an unknown concentration using a solution of known concentration. Karl Fischer titration is a specific and widely used titration method to determine the water content of raw materials and finished products.
Residual Analysis Optimized for Static Headspace GC Applications
Static headspace GC (GC-SH) is a technique used to concentrate volatile analytes prior to analysis. It can improve detection of low level volatile analytes and minimizes matrix interference by eliminating the need to inject the sample directly.

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