| 1 | Assay & Impurity HPLC | assay impurity hplcquality checker | Assay & Impurity HPLC Quality Checker — HPLC Assay and Related Substances Control ℹ️ Utility checks critical parameters of HPLC analysis (USP , Ph. |
| 2 | Automated Liquid Handling QC | automated liquid handling qcquality checker | Automated Liquid Handling QC Quality Checker — Quality Control for Automated Liquid Handling Systems ℹ️ Utility checks critical parameters of automated liquid handlers (Hamilton, Tecan, Eppendorf, etc. |
| 3 | Automated Sterility Detection | automated sterility detection | Automated Sterility Detection Quality Checker — Evaluation of Automated Microbial Detection Systems ℹ️ Utility checks critical parameters of alternative sterility testing methods (USP , Ph. |
| 4 | Bacterial Endotoxins LAL | bacterial endotoxins lalquality checker | Bacterial Endotoxins LAL Quality Checker — Bacterial Endotoxin Testing (LAL Method) ℹ️ Utility checks critical parameters of the Bacterial Endotoxins Test (USP , Ph. |
| 5 | Bacterial Endotoxins Recombinant | bacterial endotoxins recombinant | Bacterial Endotoxins Recombinant Quality Checker — Control of Bacterial Endotoxins (Recombinant Method) ℹ️ Utility checks bacterial endotoxin content using recombinant Factor C (rFC) according to Ph. |
| 6 | Biologic Aggregate Size | biologic aggregate size | Biologic Aggregate Size Quality Checker — Control of Aggregation and Particle Size of Biologics ℹ️ Utility checks critical quality parameters of biological products: • HMW Aggregates (High Molecular Weight): ≤1. |
| 7 | Charge Variant CE | charge variant cequality checker | Charge Variant CE Quality Checker — Analysis of Monoclonal Antibody Charge Variants (CE-cIEF) ℹ️ Utility checks critical parameters of charge variant distribution: • Acidic Variants: ≤15. |
| 8 | Chiral Purity HPLC | chiral purity hplcquality checker | Chiral Purity HPLC Quality Checker — Control of Chiral Purity (HPLC) ℹ️ Utility checks critical parameters of enantiomeric purity: • Enantiomeric Excess (ee): ≥99. |
| 9 | Circular Dichroism Biologic | circular dichroism biologic | Circular Dichroism Biologic Quality Checker — Control of Biologic Structure (CD) ℹ️ Utility checks critical parameters of protein molecule conformation: • Secondary structure (ellipticity at 222 nm): within ±10% of refer… |
| 10 | Content Uniformity | content uniformity | Content Uniformity Quality Checker — Calculation of AV for Uniformity of Dosage Units ℹ️ Utility calculates Acceptance Value (AV) according to USP and Ph. |
| 11 | Delivered Dose Uniformity Inhaler | delivered dose uniformity inhaler | Delivered Dose Uniformity Inhaler Quality Checker — Delivered Dose Uniformity of Inhalers ℹ️ Utility checks critical parameters of Delivered Dose Uniformity (DDU) per USP : • Mean delivered dose: 80–120% of Label Claim (… |
| 12 | Density & Refractive Index | density refractive index | Density & Refractive Index Quality Checker — Control of Density and Refractive Index ℹ️ Utility checks critical physical parameters of liquid substances: • Density: within ±0. |
| 13 | Disintegration Tablet/Capsule | disintegration tablet capsule | Disintegration Tablet/Capsule Quality Checker — Control of Tablet and Capsule Disintegration ℹ️ Utility checks compliance of disintegration time with USP / Ph. |
| 14 | Dissolution Apparatus 1 & 2 | dissolution apparatus12 | Dissolution Apparatus 1 & 2 Quality Checker — Dissolution Testing (Apparatus 1 & 2) ℹ️ Utility assesses dissolution profile of solid dosage forms according to USP using Apparatus 1 (Basket) and Apparatus 2 (Paddle): • Me… |
| 15 | Dissolution Extended Release | dissolution extended release | Dissolution Extended Release Quality Checker — Control of ER Product Dissolution ℹ️ Utility checks dissolution profile compliance for modified-release forms: • Early time point: control of "dose dumping" • Middle time po… |
| 16 | Elemental Impurities ICP | elemental impurities icpquality checker | Elemental Impurities ICP Quality Checker — Control of Elemental Impurities (ICP-MS/OES) ℹ️ Utility checks critical parameters of toxic element content according to ICH Q3D: • Class 1 (Cd, Pb, As, Hg): Strict control due… |
| 17 | ELISA Bioassay | elisabioassay | ELISA Bioassay Quality Checker — Control of ELISA Quality ℹ️ Utility checks critical parameters of ELISA validity: • Calibration Curve Linearity (R²): ≥0. |
| 18 | Endotoxin Biologic Product | endotoxin biologic product | Endotoxin Biologic Product Quality Checker — Control of Bacterial Endotoxins (BET) ℹ️ Utility checks critical parameters of Bacterial Endotoxins Test (USP / Ph. |
| 19 | Environmental Monitoring Cleanroom | environmental monitoring cleanroom | Environmental Monitoring Cleanroom Quality Checker — Cleanroom Monitoring (EU GMP Annex 1) ℹ️ Utility checks environmental parameters compliance with EU GMP Annex 1 requirements: • Cleanliness Grades: A, B, C, D • Airbor… |
| 20 | Filter Integrity Test | filter integrity test | Filter Integrity Test Quality Checker — Control of Sterilizing Filter Integrity ℹ️ Utility checks critical parameters of filter integrity tests (USP / EU GMP Annex 1): • Bubble Point Test: Pressure must be ≥ specified mi… |
| 21 | Fluorescence Spectroscopy | fluorescence spectroscopy | Fluorescence Spectroscopy Quality Checker — Control of Fluorescence Analysis Quality ℹ️ Utility checks critical parameters of fluorescence spectroscopy: • Net Fluorescence Intensity: within specified range • Signal-to-Bl… |
| 22 | FTIR Identity | ftiridentity | FTIR Identity Quality Checker — Substance Identification by IR Spectroscopy ℹ️ Utility checks critical parameters of IR spectral identification (Ph. |
| 23 | GC-MS Screening Volatile Impurities | gcmsscreening volatile impurities | GC-MS Screening Volatile Impurities Quality Checker — Screening of Volatile Impurities (GC-MS) ℹ️ Utility checks critical parameters of volatile organic compound content: • Total volatile impurities: ≤500 ppm (example sc… |
| 24 | Heavy Metals Limit Test | heavy metals limit test | Heavy Metals Limit Test Quality Checker — Limit Test for Heavy Metals ℹ️ Utility checks compliance of heavy metals limit test results with Ph. |
| 25 | Inhalation APSD | inhalation apsdquality checker | Inhalation APSD Quality Checker — Control of Aerodynamic Particle Size Distribution (APSD) ℹ️ Utility checks critical parameters of inhaler aerosol cloud (USP / Ph. |
| 26 | LC-MS Confirmation | lcmsconfirmation | LC-MS Confirmation Quality Checker — Structural Confirmation by LC-MS ℹ️ Utility checks critical parameters of substance identification by High Resolution Mass Spectrometry (HRMS): • Mass Error: ≤5. |
| 27 | Loss On Drying | loss on drying | Loss On Drying Quality Checker — Control of Loss on Drying (LOD) ℹ️ Utility checks compliance of loss on drying with pharmacopoeial requirements (Ph. |
| 28 | Melting Point | melting point | Melting Point Quality Checker — Control of Melting Point ℹ️ Utility checks compliance of melting point with pharmacopoeial requirements (Ph. |
| 29 | Microbial Enumeration (TAMC/TYMC) | microbial enumeration tamctymcquality checker | Microbial Enumeration (TAMC/TYMC) Quality Checker — Control of Microbiological Quality ℹ️ Utility checks compliance of microbiological parameters with USP / Ph. |
| 30 | Microbial Identification System | microbial identification system | Microbial Identification System Quality Checker — Control of Microbial Identification Quality ℹ️ Utility checks reliability of microbial identification results (MALDI-TOF MS / Biochemical Systems): • Log Score (Confidenc… |
| 31 | Microwave Digestion Prep | microwave digestion prep | Microwave Digestion Prep Quality Checker — Control of Microwave Digestion Quality ℹ️ Utility checks critical parameters of sample preparation for elemental analysis: • Temperature: reaching target value (e. |
| 32 | NMR Structure | nmrstructure | NMR Structure Quality Checker — Control of NMR Spectrum Quality ℹ️ Utility checks critical parameters of Nuclear Magnetic Resonance spectra quality (USP / Ph. |
| 33 | Osmolality | osmolality | Osmolality Quality Checker — Control of Solution Osmolality ℹ️ Utility checks compliance of osmolality with specified limits (USP / Ph. |
| 34 | Package Integrity & Leak Test | package integrity leak test | Package Integrity & Leak Test Quality Checker — Control of Package Integrity (CCIT) ℹ️ Utility checks compliance of leak test results with USP requirements: • Measured leak value must be strictly below the established Re… |
| 35 | Particle Count Injection USP <788> | particle count injection usp788 | Particle Count Injection USP Quality Checker — Control of Subvisible Particles in Injections ℹ️ Utility checks compliance of subvisible particle content with USP requirements: • For small volumes ( regulates permissible… |
| 36 | pH & Conductivity Water | p hconductivity water | pH & Conductivity Water Quality Checker — Control of Pharmaceutical Water Quality ℹ️ Utility checks critical parameters of Purified Water (PW) and Water for Injection (WFI): • Conductivity: ≤1. |
| 37 | Potentiometric Titration | potentiometric titration | Potentiometric Titration Quality Checker — Control of Potentiometric Titration Quality ℹ️ Utility calculates and verifies active substance content by potentiometric titration: • Calculation of Assay % based on titrant vo… |
| 38 | Powder Flow | powder flow | Powder Flow Quality Checker — Control of Powder Flowability ℹ️ Utility checks critical flowability parameters according to USP : • Carr's Index: ≤15% (Good flowability) • Hausner Ratio: ≤1. |
| 39 | Preparative LC Fraction | preparative lcfraction | Preparative LC Fraction Quality Checker — Control of Preparative HPLC Fraction Quality ℹ️ Utility checks critical parameters of collected fractions: • Purity (by analytical HPLC): ≥95. |
| 40 | Protein Concentration UV | protein concentration uvquality checker | Protein Concentration UV Quality Checker — Control of Protein Concentration and Purity (UV) ℹ️ Utility checks critical parameters of protein analysis by UV spectrophotometry: • Calculated concentration: within ±10% of ex… |
| 41 | Pyrogen Test (Rabbit & MAT) | pyrogen test rabbit matquality checker | Pyrogen Test (Rabbit & MAT) Quality Checker — Control of Pyrogenicity ℹ️ Utility checks pyrogen test results according to USP and Ph. |
| 42 | Raman Identity | raman identity | Raman Identity Quality Checker — Substance Identification by Raman Spectroscopy ℹ️ Utility checks critical parameters of Raman spectral identification: • Hit Quality Index (HQI / Correlation): ≥0. |
| 43 | Rapid Micro Alternative Method | rapid micro alternative method | Rapid Micro Alternative Method Quality Checker — Control of Rapid Microbiological Methods (RMM) ℹ️ Utility checks critical parameters of alternative microbiological tests (USP ): • Measured value: below threshold (Cut-of… |
| 44 | Residual Solvents GC | residual solvents gcquality checker | Residual Solvents GC Quality Checker — Residual Solvents Control (GC) ℹ️ Utility checks residual solvent content according to ICH Q3C guidelines: • Class 1 (Avoid): Benzene (≤2 ppm) — carcinogen • Class 2 (Limit): Methan… |
| 45 | Sample Prep Homogenization | sample prep homogenization | Sample Prep Homogenization Quality Checker — Homogenization Control for Sample Preparation ℹ️ Utility assesses the homogeneity of pharmaceutical powders and blends before analysis or compression: • RSD (Relative Standard… |
| 46 | Semisolid IVRT | semisolid ivrtquality checker | Semisolid IVRT Quality Checker — In Vitro Release Testing for Semisolid Dosage Forms ℹ️ Utility assesses the release kinetics of drug substances from ointments, creams, and gels according to USP : • Release Rate (must ma… |
| 47 | Specified Microorganisms | specified microorganisms | Specified Microorganisms Quality Checker — Control of Specified Microorganisms ℹ️ Utility checks for the absence of pathogenic microorganisms in non-sterile pharmaceutical products according to Ph. |
| 48 | SPR Binding Affinity | sprbinding affinity | SPR Binding Affinity Quality Checker — Control of Binding Affinity (SPR) ℹ️ Utility assesses the kinetics of interaction of biological products (e. |
| 49 | Stability Condition Monitoring | stability condition monitoring | Stability Condition Monitoring Quality Checker — Stability Storage Condition Monitoring ℹ️ Utility checks compliance of climate chamber parameters with ICH Q1A(R2) requirements for stability studies: • Long Term: 25°C ±… |
| 50 | Sterility Test Membrane Filtration | sterility test membrane filtration | Sterility Test Membrane Filtration Quality Checker — Sterility Testing (Membrane Filtration Method) ℹ️ Utility checks sterility test results of medicinal products by membrane filtration method according to Ph. |
| 51 | Tablet Hardness & Friability | tablet hardness friability | Tablet Hardness & Friability Quality Checker — Control of Tablet Hardness and Friability ℹ️ Utility assesses mechanical strength of tablets according to USP (Hardness) and USP (Friability): • Average Hardness: ≥50 N (New… |
| 52 | Thermal Analysis DSC/TGA | thermal analysis dsc tgaquality checker | Thermal Analysis DSC/TGA Quality Checker — Thermal Analysis (DSC/TGA) ℹ️ Utility assesses thermal properties of pharmaceutical substances using Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA)… |
| 53 | TOC Water | tocwater | TOC Water Quality Checker — Control of Total Organic Carbon in Water ℹ️ Utility checks the quality of Purified Water (PW) and Water for Injection (WFI) according to USP (TOC) and USP (Conductivity): • Total Organic Carbo… |
| 54 | UV-Vis Identity & Assay | uvvis identity assay | UV-Vis Identity & Assay Quality Checker — Control of Identity and Content (UV Spectroscopy) ℹ️ Utility checks identity and quantitative content of active pharmaceutical ingredients by UV spectroscopy according to Pharmac… |
| 55 | Viscosity & Rheology | viscosity rheology | Viscosity & Rheology Quality Checker — Control of Viscosity and Rheology ℹ️ Utility assesses rheological parameters of pharmaceutical liquids, gels, and ointments according to USP : • Dynamic Viscosity (cP or mPa·s) — re… |
| 56 | Water Activity | water activity | Water Activity Quality Checker — Control of Water Activity (Aw) ℹ️ Utility checks Water Activity (Aw) of pharmaceutical products according to Ph. |
| 57 | Water Content KF | water content kfquality checker | Water Content KF Quality Checker — Water Content Control (Karl Fischer Method) ℹ️ Utility checks water content by Karl Fischer titration according to Ph. |
| 58 | Water Microbiology | water microbiology | Water Microbiology Quality Checker — Control of Water Microbiological Purity ℹ️ Utility checks microbiological quality of Purified Water (PW) and Water for Injection (WFI) according to Ph. |
| 59 | Weight Variation Tablet/Capsule | weight variation tablet capsule | Weight Variation Tablet/Capsule Quality Checker — Control of Weight Variation for Tablets and Capsules ℹ️ Utility assesses weight uniformity of dosage forms (tablets and capsules) according to USP (Weight Variation Metho… |
| 60 | XRPD Polymorph | xrpdpolymorph | XRPD Polymorph Quality Checker — Polymorph Control (X-Ray Powder Diffraction) ℹ️ Utility identifies polymorphic form and assesses crystallinity degree of active pharmaceutical ingredients by XRPD: • Form Identification:… |