Article: Gastroenterology QC Suite

QC package for gastroenterology: PPIs, antiemetics, prokinetics, IBD medicines, laxatives, enzymes and GI anti-infectives.

Package purpose

QC package for gastroenterology: PPIs, antiemetics, prokinetics, IBD medicines, laxatives, enzymes and GI anti-infectives.

Utility count: 57. The package is intended for QC laboratories, QA, CSV and LIMS/ELN/MES integration.

Data

Typical flow: instrument or LIMS creates input.csv, the utility performs rule-based checks and returns output.json.

Validation

Each utility is supported by URS/FS and scenarios that can be used for IQ/OQ/PQ preparation.

Licensing

Licensing can be discussed as an as-is legal-entity licence without resale rights, a LIMS/ELN/MES integration module, or a pilot package for a production site/laboratory. Representative contacts are rendered from the portal configuration.

Utilities and checked parameters

#API / productUtilityKey checks
1Actinium225actinium225Actinium-225 Quality Checker — Actinium-225 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of actinium-225: • Specific activity (≥500 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Free actinium (≤5% for co…
2Alverine Citratealverine citrateAlverine Citrate Quality Checker — Alverine citrate quality assessment (BP/Ph.
3BisacodylbisacodylBisacodyl Quality Checker — Bisacodyl quality assessment (BP/Ph.
4CimetidinecimetidineCimetidine Quality Checker — Cimetidine quality assessment (BP/Ph.
5DomperidonedomperidoneDomperidone Quality Checker — Domperidone quality assessment (BP/Ph.
6Enoxaparin Sodiumenoxaparin sodiumEnoxaparin Sodium Quality Checker — Low Molecular Weight Heparin (Ph.
7EsomeprazoleesomeprazoleEsomeprazole Quality Checker — Esomeprazole quality assessment (Ph.
8Gallium68 FAPIgallium68 fapiquality checkerGallium-68 FAPI Quality Checker — ⁶⁸Ga-FAPI for PET imaging of tumor stroma ℹ️ Utility checks quality of FAPI (Fibroblast Activation Protein Inhibitor) radiopharmaceutical: • Specific activity (≥50 GBq/μmol) • Radiochemical purity (≥95%) •…
9Gastrodia Elata Rhizomegastrodia elata rhizomeGastrodia Elata Rhizome Quality Checker — Quality control of Gastrodia elata rhizome ℹ️ The utility checks gastrodin content, loss on drying, total ash, and ash insoluble in HCl.
10Heparin Sodiumheparin sodiumHeparin Sodium Quality Checker — Unfractionated Heparin (Ph.
11LactuloselactuloseLactulose Quality Checker — Osmotic Laxative (Ph. Eur., USP) ℹ️ The utility checks lactulose content, lactose, HMF, osmolality, microbiology. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
12LansoprazolelansoprazoleLansoprazole Quality Checker — Lansoprazole quality assessment (Ph.
13Lead212lead212Lead-212 Quality Checker — Lead-212 for targeted alpha therapy (TAT) ℹ️ Utility checks critical parameters of lead-212: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Daughter nuclides: bismuth-212 (≤5%),…
14LoperamideloperamideLoperamide Quality Checker — Loperamide quality assessment (Ph.
15Lutetium177 DOTATATElutetium177 dotatatequality checkerLutetium-177 DOTATATE Quality Checker — Lutetium-177 DOTATATE solution (Lutathera®) (Ph.
16MesalazinemesalazineMesalazine Quality Checker — Anti-inflammatory Agent (Ph.
17MetoclopramidemetoclopramideMetoclopramide Quality Checker — Prokinetic Agent (Ph.
18MetronidazolemetronidazoleMetronidazole Quality Checker — Metronidazole quality assessment (Ph.
19Neomycin Sulfateneomycin sulfateNeomycin Sulfate Quality Checker — Neomycin sulfate quality assessment (BP/Ph.
20Ofloxacin Ornidazoleofloxacin ornidazoleOfloxacin Ornidazole Quality Checker — Combo Antibiotic/Antiprotozoal ℹ️ The utility checks content of both APIs, nitro-impurities, synchronous dissolution.
21OmeprazoleomeprazoleOmeprazole Quality Checker — Omeprazole quality assessment (BP/Ph.
22Ondansetron Hydrochloride Dihydrateondansetron hydrochloride dihydrateOndansetron Hydrochloride Dihydrate Quality Checker — Ondansetron hydrochloride dihydrate quality assessment (Ph.
23PancreatinpancreatinPancreatin Quality Checker — Enzyme Preparation (Ph.
24PantoprazolepantoprazolePantoprazole Quality Checker — Pantoprazole quality assessment (Ph.
25Pantoprazole Domperidonepantoprazole domperidonePantoprazole Domperidone Quality Checker — Combo Product (GI Tract) ℹ️ The utility checks content of both APIs, pantoprazole degradation, moisture, uniformity.
26Rabeprazole Sodiumrabeprazole sodiumRabeprazole Sodium Quality Checker — Rabeprazole sodium quality assessment (Ph.
27SucralfatesucralfateSucralfate Quality Checker — Gastroprotective Agent (Ph.
28SulfasalazinesulfasalazineSulfasalazine Quality Checker — Sulfasalazine quality assessment (Ph.
29Ursodeoxycholic Acidursodeoxycholic acidUrsodeoxycholic Acid Quality Checker — Bile Acid (Ph.
30Astatine-211astatine211Utility description: Astatine-211 Astatine-211 Quality Checker — Astatine-211 for targeted alpha therapy ℹ️ Utility checks critical parameters of astatine-211: • Radionuclidic purity (≥99.
31Bismuth-213bismuth213Utility description: Bismuth-213 Bismuth-213 Quality Checker — Bismuth-213 for targeted alpha therapy ℹ️ Utility checks critical parameters of bismuth-213: • Radionuclidic purity (≥99.
32Copper-64 ATSMcopper64 atsmCopper-64 ATSM Quality Checker — Copper-64 ATSM for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [64Cu]Cu-ATSM: • Radionuclidic purity (≥99.
33Fluorine-18 FMISOfluorine18 fmisoFluorine-18 FMISO Quality Checker — Fluorine-18 FMISO for PET Hypoxia Imaging ℹ️ Utility checks critical parameters of [18F]FMISO (Fluoromisonidazole): • Radionuclidic purity (≥99.
34Iodine-131 Lipiodoliodine131 lipiodolIodine-131 Lipiodol Quality Checker — Iodine-131 Lipiodol for radioembolization and therapy ℹ️ Utility checks critical parameters of Iodine-131 Lipiodol: • Radionuclidic purity (≥99.
35Lutetium-177 DOTATOClutetium177 dotatocLutetium-177 DOTATOC Quality Checker — Lutetium-177 DOTATOC for Peptide Receptor Radionuclide Therapy (PRRT) ℹ️ Utility checks critical parameters of Lutetium-177 DOTATOC: • Radionuclidic purity (≥99.
36Nitrogen-13 Ammonianitrogen13 ammoniaNitrogen-13 Ammonia Quality Checker — Nitrogen-13 Ammonia for Cardiac PET Imaging ℹ️ Utility checks critical parameters of [13N]Ammonia: • Radionuclidic purity (≥99.
37Tc-99m RBCtechnetium99m red blood cell checkerTc-99m RBC Quality Checker — Technetium-99m Labeled Red Blood Cells for Heart and GI Tract ℹ️ Utility checks critical parameters of Tc-99m RBC: • Labeling efficiency (≥95%) • Free pertechnetate (≤3%) • Colloidal technetium (≤2%) • pH (4.
38Tc-99m Sulfur Colloidtechnetium99m sulfur colloid checkerTc-99m Sulfur Colloid Quality Checker — Technetium-99m Sulfur Colloid ℹ️ Utility checks critical parameters of Tc-99m Sulfur Colloid: • Radiochemical purity (≥92%) • Particle size (depends on application: liver/lymph) • Boiling time (3-6 mi…
39Thallium-201 Chloridethallium201 chlorideThallium-201 Chloride Quality Checker — Thallium-201 Chloride for Cardiology and Oncology ℹ️ Utility checks critical parameters of Thallium-201: • Radionuclidic purity (≥99.
40Zirconium-89 Trastuzumabzirconium89 trastuzumabZirconium-89 Trastuzumab Quality Checker — Zirconium-89 Trastuzumab for HER2-PET ℹ️ Utility checks critical parameters of Zr-89-Trastuzumab: • Immunoreactivity (≥80%) — MAIN PARAMETER!
41AAS/ICP-MS Elemental Impurities Class 2Baas elemental impurities class2 bUtility description: AAS/ICP-MS Elemental Impurities Class 2B AAS/ICP-MS Elemental Impurities Class 2B — Class 2B Elements Control (ICH Q3D) ℹ️ Utility checks 14 Class 2B elements according to ICH Q3D: • Thallium (Tl) ≤0.
42CE Peptide Map Validatorce peptide map validatorUtility description: CE Peptide Map Validator CE Peptide Map Validator — Peptide Mapping Validation (CE/HPLC) ℹ️ Utility compares sample peptide map with reference: • Sequence coverage ≥95.
43Drotaverine Hydrochloride Quality Checkerdrotaverine hydrochloride checkerUtility description: Drotaverine Hydrochloride Quality Checker Drotaverine Hydrochloride Quality Checker — Drotaverine Hydrochloride (No-Spa) ℹ️ Utility checks critical parameters of Drotaverine Hydrochloride API: • Assay (99.
44InfraLUM ID Daclatasvirinfra lum id daclatasvirUtility description: InfraLUM ID Daclatasvir InfraLUM ID Daclatasvir — Daclatasvir Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
45InfraLUM ID Fluconazoleinfra lum id fluconazoleUtility description: InfraLUM ID Fluconazole InfraLUM ID Fluconazole — Fluconazole Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
46InfraLUM ID Omeprazoleinfra lum id omeprazoleUtility description: InfraLUM ID Omeprazole InfraLUM ID Omeprazole — Omeprazole Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
47NIR Blend Uniformity Checkernir blend uniformity checkerUtility description: NIR Blend Uniformity Checker NIR Blend Uniformity Checker — Assessment of Blend Homogeneity via Near-Infrared Spectroscopy ℹ️ Utility checks critical parameters of powder blend homogeneity: • Mean API Content: 95.
48Omeprazole Assay Checkeromeprazole assay checkerUtility description: Omeprazole Assay Checker Omeprazole Assay Checker — Omeprazole Quality Control ℹ️ Utility checks critical quality parameters of omeprazole: • Assay content: 98.
49CE Peptide Map Fingerprintce peptide map fingerprintUtility description: CE Peptide Map Fingerprint CE Peptide Map Fingerprint — Peptide Mapping of Proteins (CE) ℹ️ Utility checks critical parameters of recombinant protein peptide maps: • Peak Count: ≥20 (depends on protein and protease) • S…
50NIR Real-Time Blend Endpointnir real time blend endpointUtility description: NIR Real-Time Blend Endpoint NIR Real-Time Blend Endpoint — Determination of Blending Endpoint in Real-Time (PAT) ℹ️ Utility controls blending process using NIR spectroscopy data: • Homogeneity Metric (e.
51Charge Variant CEcharge variant cequality checkerCharge Variant CE Quality Checker — Analysis of Monoclonal Antibody Charge Variants (CE-cIEF) ℹ️ Utility checks critical parameters of charge variant distribution: • Acidic Variants: ≤15.
52Dissolution Apparatus 1 & 2dissolution apparatus12Dissolution 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): • Mean Dissolution ≥ Q (…
53Powder Flowpowder flowPowder 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.
54Specified Microorganismsspecified microorganismsSpecified Microorganisms Quality Checker — Control of Specified Microorganisms ℹ️ Utility checks for the absence of pathogenic microorganisms in non-sterile pharmaceutical products according to Ph.
55Stability Condition Monitoringstability condition monitoringStability 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 ± 2°C / 60% RH ± 5% RH…
56Tablet Hardness & Friabilitytablet hardness friabilityTablet 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 (Newtons) — ensures inte…
57Viscosity & Rheologyviscosity rheologyViscosity & 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) — resistance to flow • S…