Диабет
Пакет для противодиабетических препаратов: инсулины, метформин, SGLT2/DPP-4/GLP-1 препараты, глюкагон и сопутствующие проверки качества лекарственных форм.
Почему выбирают FUZKK
✓ Меньше Excel-рисков
Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.
🔍 Готовность к аудиту
Готовность к аудиту (IQ/OQ): каждая утилита пакета поставляется с URS/FS, CSV-контрактом, JSON-выходом и структурой данных, пригодной для CSV/CSA, OQ/PQ и QA/QC review.
⏱ Время лаборатории
Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.
🚀 Интеграция
Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.
Схема интеграции
Утилиты в пакете
| Утилита | API / Monograph | Категории | Теги | |
|---|---|---|---|---|
| AcarboseQualityChecker | Acarbose | BP monographs | API assay British Pharmacopoeia impurities | |
| BioburdenChecker | Bioburden | EAEU pharmacopoeia, Sterile liquids | contrast media dialysis dissolution EAEU | |
| BiotinQualityChecker | Biotin | BP monographs, Vitamins and minerals | API assay British Pharmacopoeia heavy metals | |
| CanagliflozinQualityChecker | Canagliflozin | Global API expansion | antivirals API biologics dissolution | |
| CE_Peptide_Map_Fingerprint | CE Peptide Map Fingerprint | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis, Capillary electrophoresis / CE QC | Lumex QC URS & FS input.csv | |
| CE_Recombinant_Protein_Purity | CE Recombinant Protein Purity | Pharmaceutical QC, Lumex, Instrumental analysis, Capillary electrophoresis | Lumex QC URS & FS input.csv | |
| ChromiumChlorideQualityChecker | Chromium Chloride | Vitamins and minerals | assay heavy metals impurities minerals | |
| DapagliflozinQualityChecker | Dapagliflozin | Global API | API assay biosimilars dissolution | |
| DapagliflozinMetforminQualityChecker | Dapagliflozin Metformin | Global API | API assay biosimilars dissolution | |
| DesmopressinQualityChecker | Desmopressin | BP monographs | API assay British Pharmacopoeia impurities | |
| DulaglutideQualityChecker | Dulaglutide | Global API expansion | antivirals API biologics endotoxins | |
| DuloxetineHydrochlorideQualityChecker | Duloxetine Hydrochloride | BP monographs | API assay British Pharmacopoeia impurities | |
| EmpagliflozinQualityChecker | Empagliflozin | Global API | API assay biosimilars dissolution | |
| Excipients_Sugars_Polyols_HPLC | Excipients Sugars Polyols HPLC | Pharmaceutical QC, Lumex, Excipients, General QC, Excipient QC | Lumex QC URS & FS input.csv | |
| ExenatideQualityChecker | Exenatide | Global API expansion | antivirals API biologics endotoxins | |
| Fluorine18DOPAQualityChecker | Fluorine-18 DOPA | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv | |
| Fluorine18FDGQualityChecker | Fluorine18 FDG | Radiopharmaceuticals | decay correction endotoxins heavy metals medical gases | |
| Fluorine18FLTQualityChecker | Fluorine-18 FLT | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv | |
| GliclazideQualityChecker | Gliclazide | Global API | API assay biosimilars dissolution | |
| GlimepirideQualityChecker | Glimepiride | BP monographs | API assay British Pharmacopoeia impurities | |
| GlimepirideMetforminQualityChecker | Glimepiride Metformin | Global API | API assay biologics biosimilars | |
| GlipizideQualityChecker | Glipizide | BP monographs | API assay British Pharmacopoeia impurities | |
| GliquidoneQualityChecker | Gliquidone | BP monographs | API assay British Pharmacopoeia impurities | |
| GlucagonQualityChecker | Glucagon | Global API expansion | antivirals API biologics endotoxins | |
| GlucoseInfusionQualityChecker | Glucose Infusion | Sterile liquids | contrast media dialysis endotoxins infusions | |
| HemodialysisSolutionQualityChecker | Hemodialysis Solution | Sterile liquids | contrast media dialysis endotoxins infusions | |
| HumanInsulinQualityChecker | Human Insulin | Global API | API assay biologics biosimilars | |
| Indium111PentetreotideQualityChecker | Indium-111 Pentetreotide | Radiopharmaceutical QC, Radiopharmaceuticals, PetRad3 | radiopharmaceuticals QC URS & FS input.csv | |
| InfraLUM_ID_Metformin | InfraLUM ID Metformin | Pharmaceutical QC, Lumex, Instrumental analysis, IR identification, Infrared identification | Lumex QC URS & FS input.csv | |
| InsulinQualityChecker | Insulin | BP monographs | API assay biologics British Pharmacopoeia | |
| InsulinAspartQualityChecker | Insulin Aspart | Global API | API assay biologics biosimilars | |
| InsulinGlargineQualityChecker | Insulin Glargine | Global API | API assay biologics biosimilars | |
| InsulinHumanHPLCChecker | Insulin Human HPLC Checker | Pharmaceutical QC, Lumex, Biologics QC, Complex molecules, Biologics / complex molecules | Lumex QC URS & FS input.csv | |
| InsulinHumanPremixQualityChecker | Insulin Human Premix | Global API, Global API expansion | antivirals API assay biologics | |
| InsulinLisproQualityChecker | Insulin Lispro | Global API | API assay biologics biosimilars | |
| IronChecker | Iron | EAEU pharmacopoeia | antibiotics dissolution EAEU impurities | |
| LinagliptinQualityChecker | Linagliptin | Global API expansion | antivirals API biologics dissolution | |
| LiraglutideQualityChecker | Liraglutide | Global API expansion | antivirals API biologics endotoxins | |
| LossOnDryingChecker | Loss On Drying | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MannitolQualityChecker | Mannitol | Global API expansion | antivirals API biologics dissolution | |
| MeltingPointChecker | Melting Point | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| MetforminHydrochlorideQualityChecker | Metformin Hydrochloride | BP monographs | API assay British Pharmacopoeia impurities | |
| MetforminHydrochloridePurityChecker | Metformin Hydrochloride Purity Checker | Pharmaceutical QC, Lumex, API QC, Impurities / assay, API impurities / assay | Lumex QC URS & FS input.csv | |
| NateglinideQualityChecker | Nateglinide | BP monographs | API assay biologics British Pharmacopoeia | |
| PeritonealDialysisSolutionQualityChecker | Peritoneal Dialysis Solution | Sterile liquids | contrast media dialysis endotoxins infusions | |
| PioglitazoneQualityChecker | Pioglitazone | Global API | API assay biologics biosimilars | |
| RepaglinideQualityChecker | Repaglinide | Global API expansion | antivirals API biologics dissolution | |
| SaxagliptinQualityChecker | Saxagliptin | Global API expansion | antivirals API biologics dissolution | |
| SemaglutideQualityChecker | Semaglutide | Global API expansion | antivirals API biologics dissolution | |
| SitagliptinMetforminQualityChecker | Sitagliptin Metformin | Global API | API assay biologics biosimilars | |
| SitagliptinPhosphateMonohydrateQualityChecker | Sitagliptin Phosphate Monohydrate | BP monographs | API assay British Pharmacopoeia impurities | |
| SubstanceSpecificationChecker | Substance Specification | EAEU pharmacopoeia | dissolution EAEU heavy metals impurities | |
| SulfatesChecker | Sulfates | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TabletFriabilityChecker | Tablet Friability | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| TabletHardnessChecker | Tablet Hardness | EAEU pharmacopoeia | dissolution EAEU impurities microbiology | |
| VildagliptinQualityChecker | Vildagliptin | Global API | API assay biosimilars dissolution | |
| VildagliptinMetforminQualityChecker | Vildagliptin Metformin | Global API | API assay biologics biosimilars | |
| WaterContentKFQualityChecker | Water Content KF | Laboratory QC / instrumental methods | LabEx laboratory QC CSV→JSON URS & FS |
Лицензирование и поддержка
Лицензирование и поддержка: пакет поставляется как набор QC-утилит для одной компании или производственной площадки, с возможной поддержкой пилота, LIMS/ELN/MES-интеграции и подготовки к валидации.