Article: Endocrinology QC Suite

QC package for endocrinology: thyroid, pituitary/peptide hormones, corticosteroids, sex hormones and selected metabolic medicines.

Package purpose

QC package for endocrinology: thyroid, pituitary/peptide hormones, corticosteroids, sex hormones and selected metabolic medicines.

Utility count: 105. 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…
2BetamethasonebetamethasoneBetamethasone Quality Checker — Betamethasone quality assessment (BP/Ph.
3CarbimazolecarbimazoleCarbimazole Quality Checker — Carbimazole quality assessment (Ph.
4Chlormadinone Acetatechlormadinone acetateChlormadinone Acetate Quality Checker — Chlormadinone Acetate (Progestogen) (Ph.
5CinacalcetcinacalcetCinacalcet Quality Checker — Calcimimetic (Ph. Eur., USP) ℹ️ The utility checks assay, related impurities, toluene/acetonitrile, dissolution profile, uniformity. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
6Contrast Media Iodinecontrast media iodineContrast Media Iodine Quality Checker — Iodinated contrast media quality assessment (Ph.
7Copper67copper67Copper-67 Quality Checker — Copper-67 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of copper-67: • Specific activity (≥100 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Copper-64 impurity (≤0.
8Cyproterone Acetate Ethinylestradiolcyproterone acetate ethinylestradiolCyproterone Acetate + Ethinylestradiol Quality Checker — Combined Tablets (Diane-35, Androcur) (Ph.
9DesmopressindesmopressinDesmopressin Quality Checker — Desmopressin quality assessment (BP/Ph.
10DesogestreldesogestrelDesogestrel Quality Checker — Desogestrel (Progestogen for Mini-Pills and Implants) (Ph.
11DexamethasonedexamethasoneDexamethasone Quality Checker — Dexamethasone quality assessment (BP/Ph.
12DienogestdienogestDienogest Quality Checker — Dienogest (Progestogen for Endometriosis and COCs) (Ph.
13DrospirenonedrospirenoneDrospirenone Quality Checker — Drospirenone (Anti-Aldosterone Progestogen for COCs) (Ph.
14EstradiolestradiolEstradiol Quality Checker — Estradiol quality assessment (BP/Ph.
15Ethinylestradiol Chlormadinoneethinylestradiol chlormadinoneEthinylestradiol + Chlormadinone Acetate Quality Checker — Combined Tablets (Belara) (Ph.
16Ethinylestradiol Desogestrelethinylestradiol desogestrelEthinylestradiol + Desogestrel Quality Checker — Combined Tablets (Novinet, Mercilon) (Ph.
17Ethinylestradiol Dienogestethinylestradiol dienogestEthinylestradiol + Dienogest Quality Checker — Combined Tablets (Claira, Nata) (Ph.
18Ethinylestradiol Drospirenoneethinylestradiol drospirenoneEthinylestradiol + Drospirenone Quality Checker — Combined Tablets (Yasmin, Jeanine, Drospirenone) (Ph.
19Ethinylestradiol Gestodeneethinylestradiol gestodeneEthinylestradiol + Gestodene Quality Checker — Combined Tablets (Minisiston, Marvelon) (Ph.
20Ethinylestradiol Levonorgestrelethinylestradiol levonorgestrelEthinylestradiol + Levonorgestrel Quality Checker — Combined Tablets (Regulon, Microgynon, Norinyl) (Ph.
21Ethinylestradiol Nomegestrolethinylestradiol nomegestrolEthinylestradiol + Nomegestrol Acetate Quality Checker — Combined Tablets (Zoely) (Ph.
22Ethinylestradiol Norethisteroneethinylestradiol norethisteroneEthinylestradiol + Norethisterone Quality Checker — Combined Tablets (Microgynon 30, Norinyl-1, Ovcon) (Ph.
23Ethinylestradiol Norgestimateethinylestradiol norgestimateEthinylestradiol + Norgestimate Quality Checker — Combined Tablets (Cilest, Sprintec) (Ph.
24Etonogestrel Ethinylestradiol Ringetonogestrel ethinylestradiol ringEtonogestrel + Ethinylestradiol Ring Quality Checker — Vaginal Ring (NuvaRing, Vaginorm) (Ph.
25Fatty Acids Profile Validatorfatty acids profile validatorFatty Acids Profile Validator — Анализ профиля жирных кислот (Ph.
26Gallium68 DOTATATEgallium68 dotatatequality checkerGallium-68 DOTATATE Quality Checker — ⁶⁸Ga-DOTATATE (NETSPOT®) for neuroendocrine tumor PET imaging (Ph.
27Gallium68 Generatorgallium68 generatorGallium-68 Generator Quality Checker — ⁶⁸Ge/⁶⁸Ga generator for PET diagnostics (Ph.
28Glimepiride Metforminglimepiride metforminGlimepiride Metformin Quality Checker — Combo Product (Sulfonylurea + Biguanide) ℹ️ The utility checks content of both APIs, content uniformity (low dose glimepiride), metformin impurities, dissolution.
29GlucagonglucagonGlucagon Quality Checker — Biologic Drug (Peptide Hormone) (Ph.
30Human Insulinhuman insulinHuman Insulin Quality Checker — Biologic Drug (Peptide Hormone) (Ph.
31HydrocortisonehydrocortisoneHydrocortisone Quality Checker — Hydrocortisone quality assessment (Ph.
32I131 Volatility Extendedi131 volatility extended checkerI-131 Volatility Extended Checker — Extended volatile iodine control in iodine-131 capsules ℹ️ Utility performs DEEP analysis of volatile iodine with: • Current value check (≤5.
33InsulininsulinInsulin Quality Checker — Human insulin quality assessment (BP/Ph.
34Insulin Aspartinsulin aspartInsulin Aspart Quality Checker — Biologic Drug (Insulin Analog) (Ph.
35Insulin Glargineinsulin glargineInsulin Glargine Quality Checker — Biologic Drug (Long-acting Insulin Analog) (Ph.
36Insulin Human Premixinsulin human premixInsulin Human Premix Quality Checker — Biologic Drug (NPH+Soluble Mix) (Ph.
37Insulin Lisproinsulin lisproInsulin Lispro Quality Checker — Biologic Drug (Rapid-acting Insulin Analog) (Ph.
38Iodine131 Capsulesiodine131 capsulesIodine-131 Capsules Quality Checker — Iodine-131 Capsules (radiopharmaceutical for thyroid therapy) (Ph.
39IodixanoliodixanolIodixanol Quality Checker — Radiographic Contrast Agent (Ph.
40IopamidoliopamidolIopamidol Quality Checker — Radiographic Contrast Agent (Ph.
41KelpkelpKelp Quality Checker — Quality control of Kelp (Laminaria) ℹ️ The utility checks iodine content, loss on drying, total ash, and ash insoluble in HCl.
42Lead212lead212Lead-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%),…
43Levothyroxine Sodiumlevothyroxine sodiumLevothyroxine Sodium Quality Checker — Thyroid Hormone (Ph.
44Lutetium177 DOTATATElutetium177 dotatatequality checkerLutetium-177 DOTATATE Quality Checker — Lutetium-177 DOTATATE solution (Lutathera®) (Ph.
45MethylprednisolonemethylprednisoloneMethylprednisolone Quality Checker — Methylprednisolone quality assessment (Ph.
46NateglinidenateglinideNateglinide Quality Checker — Nateglinide quality assessment (Ph.
47Nomegestrol Acetatenomegestrol acetateNomegestrol Acetate Quality Checker — Nomegestrol Acetate (Highly Selective Progestogen) (Ph.
48Nonoxynol9nonoxynol9Nonoxynol-9 Quality Checker — Nonoxynol-9 (Spermicidal Surfactant) (Ph.
49Norelgestromin Ethinylestradiol Patchnorelgestromin ethinylestradiol patchNorelgestromin + Ethinylestradiol Patch Quality Checker — Transdermal Patch (Evra) (Ph.
50Oil Parametersoil parameters checkerOil Parameters Checker — Pharmaceutical oil quality verification (Ph.
51PioglitazonepioglitazonePioglitazone Quality Checker — Insulin Sensitizer (Ph.
52Potassium Iodidepotassium iodidePotassium Iodide Quality Checker — Potassium Iodide (Ph.
53PrednisoloneprednisolonePrednisolone Quality Checker — Glucocorticosteroid (Ph.
54PrednisoneprednisonePrednisone Quality Checker — Glucocorticoid (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, DCM, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
55ProgesteroneprogesteroneProgesterone Quality Checker — Hormone (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile/dichloromethane, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only.…
56PropylthiouracilpropylthiouracilPropylthiouracil Quality Checker — Antithyroid Agent (Ph.
57Radiation Dose Calculatorradiation dose calculatorRadiation Dose Calculator — Patient absorbed dose calculator ℹ️ Utility calculates ESTIMATED absorbed dose based on ICRP data (ICRP 106, 128): • Effective dose (mSv) for overall radiation burden assessment • Target organ and critical organ…
58Radiochemical Purityradiochemical purity checkerRadiochemical Purity Checker — Universal utility for radiochemical purity calculation (TLC / HPLC) ℹ️ Utility calculates radiochemical purity as (target peak area / total peak area) × 100% from chromatographic analysis data.
59Sitagliptin Metforminsitagliptin metforminSitagliptin Metformin Quality Checker — Combo Product (Diabetes) ℹ️ The utility checks content of both APIs, NDMA (nitrosamines) in metformin, sitagliptin uniformity.
60Sodium Selenitesodium seleniteSodium Selenite Quality Checker — Sodium Selenite (Ph.
61Technetium99m Generatortechnetium99m generatorTechnetium-99m Generator Quality Checker — Molybdenum-technetium generator (Ph.
62TeriparatideteriparatideTeriparatide Quality Checker — Biologic Drug (Parathyroid Hormone) (Ph.
63TestosteronetestosteroneTestosterone Quality Checker — Testosterone quality assessment (BP/Ph.
64Testosterone Undecanoatetestosterone undecanoateTestosterone Undecanoate Quality Checker — Testosterone Undecanoate (Testosterone Ester for Replacement Therapy) (Ph.
65ThiamazolethiamazoleThiamazole Quality Checker — Thiamazole quality assessment (Ph.
66Ulipristal Acetateulipristal acetateUlipristal Acetate Quality Checker — Ulipristal Acetate (Selective Progesterone Receptor Modulator) (Ph.
67Vildagliptin Metforminvildagliptin metforminVildagliptin Metformin Quality Checker — Combo Product (Diabetes) ℹ️ The utility checks content of both APIs, NDMA (nitrosamines) in metformin, cyanide in vildagliptin.
68Yttrium90yttrium90Yttrium-90 Quality Checker — Yttrium-90 for radionuclide therapy ℹ️ Utility checks critical parameters of yttrium-90: • Specific activity (≥1000 MBq/μmol for conjugates) • Radiochemical purity (≥95%) • Yttrium-88 impurity (≤0.
69Astatine-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.
70Bismuth-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.
71Rhenium-186rhenium186Utility description: Rhenium-186 Rhenium-186 Quality Checker — Radiopharmaceutical (Therapy) (Ph.
72Rhenium-188rhenium188Utility description: Rhenium-188 Rhenium-188 Quality Checker — Radiopharmaceutical (Generator-based) (Ph.
73Terbium-161terbium161Utility description: Terbium-161 Terbium-161 Quality Checker — Terbium-161 for targeted radionuclide therapy ℹ️ Utility checks critical parameters of terbium-161: • Radionuclidic purity (≥99.
74Copper-64 DOTATATEcopper64 dotatateCopper-64 DOTATATE Quality Checker — Copper-64 DOTATATE for PET Imaging of Neuroendocrine Tumors ℹ️ Utility checks critical parameters of [64Cu]Cu-DOTATATE: • Radionuclidic purity (≥99.
75Fluorine-18 DOPAfluorine18 dopaFluorine-18 DOPA Quality Checker — Fluorine-18 DOPA for PET Diagnostics ℹ️ Utility checks critical parameters of [18F]FDOPA: • Radionuclidic purity (≥99.
76Fluorine-18 FESfluorine18 fesFluorine-18 FES Quality Checker — Fluorine-18 FES for PET Imaging of Estrogen Receptors ℹ️ Utility checks critical parameters of [18F]Fluoroestradiol (FES): • Radionuclidic purity (≥99.
77Indium-111 Pentetreotideindium111 pentetreotideIndium-111 Pentetreotide Quality Checker — Indium-111 Pentetreotide (OctreoScan®) ℹ️ Utility checks critical parameters of the somatostatin analog radiopharmaceutical: • Radiochemical purity (≥90%) • Free Indium-111 impurity (≤5%) • Colloid…
78Iodine-123 FP-CITiodine123 fpctIodine-123 FP-CIT Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionuclidic…
79Iodine-123 Ioflupaneiodine123 ioflupaneIodine-123 Ioflupane Quality Checker — Ioflupane I-123 (DaTscan®) ℹ️ Utility checks critical parameters of the radiopharmaceutical for dopamine transporter imaging: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionucli…
80Iodine-123 MIBGiodine123 mibgIodine-123 MIBG Quality Checker — Iodine-123 Metaiodobenzylguanidine ℹ️ Utility checks critical parameters of Iodine-123 MIBG radiopharmaceutical: • Radiochemical purity (≥95%) • Free Iodine-123 impurity (≤5%) • Radionuclidic impurity Iodin…
81Iodine-123 NaIiodine123 na iIodine-123 NaI Quality Checker — Sodium Iodide I-123 ℹ️ Utility checks critical parameters of Sodium Iodide I-123: • Radionuclidic purity (≥99% I-123) • Iodine-124 impurity (≤0.
82Iodine-124 MAbiodine124 mabIodine-124 MAb Quality Checker — Iodine-124 Monoclonal Antibodies (ImmunoPET) ℹ️ Utility checks critical parameters of Iodine-124 labeled monoclonal antibodies: • Radiochemical purity (≥90%) • Free Iodine-124 impurity (≤5%) • Immunoreactive…
83Iodine-131 Hippuraniodine131 hippuranIodine131 Hippuran Quality Checker — radiopharmaceutical QC utility.
84Iodine-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.
85Iodine-131 MIBGiodine131 mibgIodine-131 MIBG Quality Checker — Iodine-131 MIBG for neuroendocrine tumor therapy ℹ️ Utility checks critical parameters of Iodine-131 MIBG: • Radionuclidic purity (≥99.
86Lutetium-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.
87Scandium-43scandium43Scandium-43 Quality Checker — Scandium-43 for PET Imaging (Theranostics) ℹ️ Utility checks critical parameters of Scandium-43: • Radionuclidic purity (≥99.
88Tc-99m HMPAOtc99m hmpaoTc-99m HMPAO Quality Checker — Technetium-99m HMPAO for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤15%) • Free pertechnetate (≤5%) •…
89Tc-99m MAG3tc99m mag3Tc-99m MAG3 Quality Checker — Technetium-99m Mercaptide (MAG3) for Dynamic Renal Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m MAG3: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) • Boil…
90Tc-99m MDPtc99m mdpTc-99m MDP Quality Checker — Technetium-99m MDP for Bone Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m MDP: • Radiochemical purity (≥95%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) • Aluminum content (≤10 ppm) —…
91Tc-99m Sestamibitc99m sestamibiTc-99m Sestamibi Quality Checker — Technetium-99m Sestamibi (MIBI) for Cardiology and Surgery ℹ️ Utility checks critical parameters of Tc-99m Sestamibi: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) •…
92Tc-99m Tetrofosmintc99m tetrofosminTc-99m Tetrofosmin Quality Checker — Technetium-99m Tetrofosmin for Myocardial Scintigraphy ℹ️ Utility checks critical parameters of Tc-99m Tetrofosmin: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) •…
93Tc-99m ECDtechnetium99m ecdTc-99m ECD Quality Checker — Technetium-99m Bicisate (ECD) for Brain SPECT Perfusion ℹ️ Utility checks critical parameters of Tc-99m ECD: • Radiochemical purity (≥95%) • Free pertechnetate (≤2%) • Colloidal technetium (≤3%) • Stability: use…
94Tc-99m Exametazimetechnetium99m exametazimeTc-99m Exametazime Quality Checker — Technetium-99m Exametazime (HMPAO) for Brain and WBCs ℹ️ Utility checks critical parameters of Tc-99m HMPAO: • Radiochemical purity of lipophilic complex (≥80%) • Secondary complex (≤15%) • Free pertechn…
95Tc-99m Glucoheptonatetechnetium99m glucoheptonate checkerTc-99m Glucoheptonate Quality Checker — Technetium-99m Glucoheptonate for Brain and Kidneys ℹ️ Utility checks critical parameters of Tc-99m Glucoheptonate: • Radiochemical purity (≥90%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%…
96Tc-99m PYPtechnetium99m pyrophosphate checkerTc-99m PYP Quality Checker — Technetium-99m Pyrophosphate (PYP) for Bones and Heart ℹ️ Utility checks critical parameters of Tc-99m PYP: • Radiochemical purity (≥95%) • Free pertechnetate (≤5%) • Colloidal technetium (≤5%) • Aluminum conten…
97Tc-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.
98Tc-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…
99Thallium-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.
100AAS Elemental Impurities Class 2Aaas elemental impurities class2 aUtility description: AAS Elemental Impurities Class 2A AAS Elemental Impurities Class 2A — Class 2A Elements Control (ICH Q3D) ℹ️ Utility checks Class 2A elemental impurities according to ICH Q3D: • Cobalt (Co) ≤5.
101AAS Nickel Hydrogenated Oilsaas nickel hydrogenated oilsUtility description: AAS Nickel Hydrogenated Oils AAS Nickel Hydrogenated Oils — Nickel Control in Hydrogenated Oils ℹ️ Utility checks residual nickel content after catalytic hydrogenation: • Nickel (Ni) ≤1.
102CE Recombinant Protein Purityce recombinant protein purityUtility description: CE Recombinant Protein Purity CE Recombinant Protein Purity — Recombinant Protein Purity Control (SDS-CE) ℹ️ Utility checks electrophoretic purity of protein under denaturing conditions: • Main Band ≥95.
103InfraLUM ID Metformininfra lum id metforminUtility description: InfraLUM ID Metformin InfraLUM ID Metformin — Metformin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
104Insulin Human HPLC Checkerinsulin human hplccheckerUtility description: Insulin Human HPLC Checker Insulin Human HPLC Checker — Human Insulin Quality Control via HPLC ℹ️ Utility checks critical parameters of human insulin via HPLC: • Assay content: 95.
105CE 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…